Urologists
26 years of experience

6681 Laurel Rd
New Hope, PA 18938
Locations and availability (2)

Education ?

Medical School Score Rankings
Thomas Jefferson University (1984)
  • Currently 3 of 4 apples
Top 50%

Awards & Distinctions ?

Associations
American College of Surgeons
American Board of Urology

Publications & Research

Dr. Rivas has contributed to 72 publications.
Title Low Intrinsic Running Capacity is Associated with Reduced Skeletal Muscle Substrate Oxidation and Lower Mitochondrial Content in White Skeletal Muscle.
Date June 2011
Journal American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
Excerpt

Chronic metabolic diseases develop from the complex interaction of environmental and genetic factors, although the extent to which each contributes to these disorders is unknown. Here, we test the hypothesis that artificial selection for low intrinsic aerobic running capacity is associated with reduced skeletal muscle metabolism and impaired metabolic health. Rat models for low- (LCR) and high- (HCR) intrinsic running capacity were derived from genetically heterogeneous N:NIH stock for 20 generations. Artificial selection produced a 530% difference in running capacity between LCR/HCR, which was associated with significant functional differences in glucose and lipid handling by skeletal muscle, as assessed by hindlimb perfusion. LCR had reduced rates of skeletal muscle glucose uptake (∼30%; P = 0.04), glucose oxidation (∼50%; P = 0.04), and lipid oxidation (∼40%; P = 0.02). Artificial selection for low aerobic capacity was also linked with reduced molecular signaling, decreased muscle glycogen, and triglyceride storage, and a lower mitochondrial content in skeletal muscle, with the most profound changes to these parameters evident in white rather than red muscle. We show that a low intrinsic aerobic running capacity confers reduced insulin sensitivity in skeletal muscle and is associated with impaired markers of metabolic health compared with high intrinsic running capacity. Furthermore, selection for high running capacity, in the absence of exercise training, endows increased skeletal muscle insulin sensitivity and oxidative capacity in specifically white muscle rather than red muscle. These data provide evidence that differences in white muscle may have a role in the divergent aerobic capacity observed in this generation of LCR/HCR.

Title Baseline Characteristics and Treatment Outcomes for Men with Acquired or Lifelong Premature Ejaculation with Mild or No Erectile Dysfunction: Integrated Analyses of Two Phase 3 Dapoxetine Trials.
Date January 2011
Journal The Journal of Sexual Medicine
Excerpt

Premature ejaculation (PE) is classified as an acquired or lifelong condition but data on baseline characteristics and response to treatment of men with acquired or lifelong PE and mild erectile dysfunction (ED) or normal erectile function (EF) is limited.

Title Exercise Training Reverses Impaired Skeletal Muscle Metabolism Induced by Artificial Selection for Low Aerobic Capacity.
Date January 2011
Journal American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
Excerpt

We have used a novel model of genetically imparted endurance exercise capacity and metabolic health to study the genetic and environmental contributions to skeletal muscle glucose and lipid metabolism. We hypothesized that metabolic abnormalities associated with low intrinsic running capacity would be ameliorated by exercise training. Selective breeding for 22 generations resulted in rat models with a fivefold difference in intrinsic aerobic capacity. Low (LCR)- and high (HCR)-capacity runners remained sedentary (SED) or underwent 6 wk of exercise training (EXT). Insulin-stimulated glucose transport, insulin signal transduction, and rates of palmitate oxidation were lower in LCR SED vs. HCR SED (P < 0.05). Decreases in glucose and lipid metabolism were associated with decreased β₂-adrenergic receptor (β₂-AR), and reduced expression of Nur77 target proteins that are critical regulators of muscle glucose and lipid metabolism [uncoupling protein-3 (UCP3), fatty acid transporter (FAT)/CD36; P < 0.01 and P < 0.05, respectively]. EXT reversed the impairments to glucose and lipid metabolism observed in the skeletal muscle of LCR, while increasing the expression of β₂-AR, Nur77, GLUT4, UCP3, and FAT/CD36 (P < 0.05) in this tissue. However, no metabolic improvements were observed following exercise training in HCR. Our results demonstrate that metabolic impairments resulting from genetic factors (low intrinsic aerobic capacity) can be overcome by an environmental intervention (exercise training). Furthermore, we identify Nur77 as a potential mechanism for improved skeletal muscle metabolism in response to EXT.

Title Mtor Function in Skeletal Muscle: a Focal Point for Overnutrition and Exercise.
Date January 2010
Journal Applied Physiology, Nutrition, and Metabolism = Physiologie Appliquée, Nutrition Et Métabolisme
Excerpt

The mammalian target of rapamycin (mTOR) is a highly conserved atypical serine-threonine kinase that controls numerous functions essential for cell homeostasis and adaptation in mammalian cells via 2 distinct protein complex formations. Moreover, mTOR is a key regulatory protein in the insulin signalling cascade and has also been characterized as an insulin-independent nutrient sensor that may represent a critical mediator in obesity-related impairments of insulin action in skeletal muscle. Exercise characterizes a remedial modality that enhances mTOR activity and subsequently promotes beneficial metabolic adaptation in skeletal muscle. Thus, the metabolic effects of nutrients and exercise have the capacity to converge at the mTOR protein complexes and subsequently modify mTOR function. Accordingly, the aim of the present review is to highlight the role of mTOR in the regulation of insulin action in response to overnutrition and the capacity for exercise to enhance mTOR activity in skeletal muscle.

Title Impaired Skeletal Muscle Beta-adrenergic Activation and Lipolysis Are Associated with Whole-body Insulin Resistance in Rats Bred for Low Intrinsic Exercise Capacity.
Date November 2009
Journal Endocrinology
Excerpt

Rats selectively bred for high endurance running capacity (HCR) have higher insulin sensitivity and improved metabolic health compared with those bred for low endurance capacity (LCR). We investigated several skeletal muscle characteristics, in vitro and in vivo, that could contribute to the metabolic phenotypes observed in sedentary LCR and HCR rats. After 16 generations of selective breeding, HCR had approximately 400% higher running capacity (P < 0.001), improved insulin sensitivity (P < 0.001), and lower fasting plasma glucose and triglycerides (P < 0.05) compared with LCR. Skeletal muscle ceramide and diacylglycerol content, basal AMP-activated protein kinase (AMPK) activity, and basal lipolysis were similar between LCR and HCR. However, the stimulation of lipolysis in response to 10 mum isoproterenol was 70% higher in HCR (P = 0.004). Impaired isoproterenol sensitivity in LCR was associated with lower basal triacylglycerol lipase activity, Ser660 phosphorylation of HSL, and beta2-adrenergic receptor protein content in skeletal muscle. Expression of the orphan nuclear receptor Nur77, which is induced by beta-adrenergic signaling and is associated with insulin sensitivity, was lower in LCR (P < 0.05). Muscle protein content of Nur77 target genes, including uncoupling protein 3, fatty acid translocase/CD36, and the AMPK gamma3 subunit were also lower in LCR (P < 0.05). Our investigation associates whole-body insulin resistance with impaired beta-adrenergic response and reduced expression of genes that are critical regulators of glucose and lipid metabolism in skeletal muscle. We identify impaired beta-adrenergic signal transduction as a potential mechanism for impaired metabolic health after artificial selection for low intrinsic exercise capacity.

Title Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized, Double-blind, Placebo-controlled Phase 3 Trial in 22 Countries.
Date October 2009
Journal European Urology
Excerpt

Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy.

Title Glycogen Storage and Muscle Glucose Transporters (glut-4) of Mice Selectively Bred for High Voluntary Wheel Running.
Date March 2009
Journal The Journal of Experimental Biology
Excerpt

To examine the evolution of endurance-exercise behaviour, we have selectively bred four replicate lines of laboratory mice (Mus domesticus) for high voluntary wheel running (;high runner' or HR lines), while also maintaining four non-selected control (C) lines. By generation 16, HR mice ran approximately 2.7-fold more than C mice, mainly by running faster (especially in females), a differential maintained through subsequent generations, suggesting an evolutionary limit of unknown origin. We hypothesized that HR mice would have higher glycogen levels before nightly running, show greater depletion of those depots during their more intense wheel running, and have increased glycogen synthase activity and GLUT-4 protein in skeletal muscle. We sampled females from generation 35 at three times (photophase 07:00 h-19:00 h) during days 5-6 of wheel access, as in the routine selection protocol: Group 1, day 5, 16:00 h-17:30 h, wheels blocked from 13:00 h; Group 2, day 6, 02:00 h-03:30 h (immediately after peak running); and Group 3, day 6, 07:00 h-08:30 h. An additional Group 4, sampled 16:00 h-17:30 h, never had wheels. HR individuals with the mini-muscle phenotype (50% reduced hindlimb muscle mass) were distinguished for statistical analyses comparing C, HR normal, and HR mini. HR mini ran more than HR normal, and at higher speeds, which might explain why they have been favored by the selective-breeding protocol. Plasma glucose was higher in Group 1 than in Group 4, indicating a training effect (phenotypic plasticity). Without wheels, no differences in gastrocnemius GLUT-4 were observed. After 5 days with wheels, all mice showed elevated GLUT-4, but HR normal and mini were 2.5-fold higher than C. At all times and irrespective of wheel access, HR mini showed approximately three-fold higher [glycogen] in gastrocnemius and altered glycogen synthase activity. HR mini also showed elevated glycogen in soleus when sampled during peak running. All mice showed some glycogen depletion during nightly wheel running, in muscles and/or liver, but the magnitude of this depletion was not large and hence does not seem to be limiting to the evolution of even-higher wheel running.

Title Tissue-specific Effects of Rosiglitazone and Exercise in the Treatment of Lipid-induced Insulin Resistance.
Date July 2007
Journal Diabetes
Excerpt

Both pharmacological intervention (i.e., thiazolidinediones [TZDs]) and lifestyle modification (i.e., exercise training) are clinically effective treatments for improving whole-body insulin sensitivity. However, the mechanism(s) by which these therapies reverse lipid-induced insulin resistance in skeletal muscle is unclear. We determined the effects of 4 weeks of rosiglitazone treatment and exercise training and their combined actions (rosiglitazone treatment and exercise training) on lipid and glucose metabolism in high-fat-fed rats. High-fat feeding resulted in decreased muscle insulin sensitivity, which was associated with increased rates of palmitate uptake and the accumulation of the fatty acid metabolites ceramide and diacylglycerol. Impairments in lipid metabolism were accompanied by defects in the Akt/AS160 signaling pathway. Exercise training, but not rosiglitazone treatment, reversed these impairments, resulting in improved insulin-stimulated glucose transport and increased rates of fatty acid oxidation in skeletal muscle. The improvements to glucose and lipid metabolism observed with exercise training were associated with increased AMP-activated protein kinase alpha1 activity; increased expression of Akt1, peroxisome proliferator-activated receptor gamma coactivator 1, and GLUT4; and a decrease in AS160 expression. In contrast, rosiglitazone treatment exacerbated lipid accumulation and decreased insulin-stimulated glucose transport in skeletal muscle. However, rosiglitazone, but not exercise training, increased adipose tissue GLUT4 and acetyl CoA carboxylase expression. Both exercise training and rosiglitazone decreased liver triacylglycerol content. Although both interventions can improve whole-body insulin sensitivity, our results show that they produce divergent effects on protein expression and triglyceride storage in different tissues. Accordingly, exercise training and rosiglitazone may act as complementary therapies for the treatment of insulin resistance.

Title High-fat Feeding Effects on Components of the Cap/cbl Signaling Cascade in Sprague-dawley Rat Skeletal Muscle.
Date March 2006
Journal Metabolism: Clinical and Experimental
Excerpt

The aim of this investigation was to determine whether the CAP (Cbl-associated protein)/Cbl signaling cascade is present and responsive to insulin in skeletal muscle and if high-fat feeding impairs insulin-stimulated activation of this signaling cascade. Sprague-Dawley rats were assigned to either control (n = 16) or high fat-fed (n = 16) dietary groups. After a 12-week dietary period, animals were subjected to hind limb perfusions in the presence (n = 8 per group) or absence (n = 8 per group) of insulin. High-fat feeding reduced rates of insulin-stimulated skeletal muscle phosphatidylinositol 3-kinase activity and 3-O-methylglucose transport. In plasma membrane fractions, neither the high-fat diet nor insulin altered the insulin receptor beta subunit (IR-beta), APS (adaptor protein containing PH and SH2 domains), c-Cbl, or TC10 protein concentration, but high-fat feeding did decrease CAP protein concentration. APS, c-Cbl, CAP, and TC10 messenger RNA were present in the skeletal muscle and reflected the protein concentration of experimental groups. Despite insulin-stimulated plasma membrane IR-beta tyrosine phosphorylation being unaffected by high-fat feeding, c-Cbl tyrosine phosphorylation, the kinase activity of IR-beta toward APS, and glucose transporter 4 protein concentration were all significantly reduced in insulin-stimulated plasma membrane prepared from the skeletal muscle of high fat-fed animals. These findings suggest that the CAP/Cbl signaling cascade is present in skeletal muscle, activated by insulin, and impaired by high-fat feeding.

Title Insulin-stimulated Plasma Membrane Association and Activation of Akt2, Apkc Zeta and Apkc Lambda in High Fat Fed Rodent Skeletal Muscle.
Date August 2005
Journal The Journal of Physiology
Excerpt

Several recent reports using cell lines have suggested that both Akt and atypical protein kinase C (aPKC) zeta/lambda are translocated to the plasma membrane (PM) in response to insulin. However, it has yet to be determined in skeletal muscle whether: (1) insulin increases PM-associated Akt2, aPKC zeta and/or lambda protein concentration, (2) the activity of these kinases is altered by insulin at the PM, and (3) high fat feeding alters the insulin-stimulated PM concentration and/or activity of Akt2 and aPKC zeta/lambda. Sprague-Dawley rats were randomly assigned to either normal (n=16) or high fat (n=16) dietary groups. Following a 12 week dietary period, animals were subjected to hind limb perfusions in the presence (n=8 per group) or absence (n=8 per group) of insulin. In normal skeletal muscle, total PI3-kinase, Akt2 and aPKC zeta/lambda activities were increased by insulin. PM-associated aPKC zeta and lambda, and aPKC zeta/lambda activity, but not Akt2 or Akt2 activity, were increased by insulin in normal muscle. High fat feeding did not alter total skeletal muscle Akt2, aPKC zeta or aPKC lambda protein concentration. Insulin-stimulated total PI3-kinase, Akt2 and aPKC zeta/lambda activities were reduced in the high fat fed animals. Insulin-stimulated PM aPKC zeta, aPKC lambda, aPKC zeta/lambda activity and GLUT4 protein concentration were also reduced in high fat fed animals. These findings suggest that in skeletal muscle, insulin stimulates translocation of aPKC zeta and lambda, but not Akt2, to the PM. In addition, high fat feeding impairs insulin-stimulated activation of total aPKC zeta/lambda and Akt2, as well as PM association and activation of aPKC zeta and lambda.

Title Chronic Aerobic Exercise Enhances Components of the Classical and Novel Insulin Signalling Cascades in Sprague-dawley Rat Skeletal Muscle.
Date July 2005
Journal Acta Physiologica Scandinavica
Excerpt

The aim of this study was to provide a more extensive evaluation of the effects of chronic aerobic exercise on various components of the insulin signalling cascade in normal rodent skeletal muscle because of the limited body of literature that exists in this area of investigation.

Title Intravesical Resiniferatoxin for Refractory Detrusor Hyperreflexia: a Multicenter, Blinded, Randomized, Placebo-controlled Trial.
Date June 2004
Journal The Journal of Spinal Cord Medicine
Excerpt

OBJECTIVE: Resiniferatoxin (RTX) is an analogue of capsaicin with more than 1,000 times its potency in desensitizing C-fiber bladder afferent neurons. This study investigated the safety and efficacy of intravesical RTX in patients with refractory detrusor hyperreflexia (DH). METHODS: Thirty-six (22 males, 14 females) neurologically impaired patients (20 spinal cord injury, 7 multiple sclerosis, 9 other neurologic diseases) with urodynamically verified DH and intractable urinary symptoms despite previous anticholinergic drug use were treated prospectively with intravesical RTX using dose escalation in a double-blind fashion at 4 centers. Patients received a single instillation of 100 mL of placebo (n = 8 patients) or 0.005, 0.025, 0.05, 0.10, 0.2, 0.5, or 1.0 microM of RTX (n = 4 each group). A visual analog pain scale (VAPS) (0-10; 10 = highest level of pain) was used to quantify discomfort of application. Treatment effect was monitored using a bladder diary and cystometric bladder capacity at weeks 1, 3, 6, and 12 posttreatment. RESULTS: Mean VAPS scores revealed minimal to mild discomfort with values of 2.85 and 2.28 for the 0.5-microM and 1.0-microM RTX treatment groups, respectively. Due to the small sample size, there were no statistically significant changes in mean cystometric capacity (MCC) or incontinence episodes in each treatment dose group. However, at 3 weeks, MCC increased by 53% and 48% for the 0.5-microM and 1.0-microM RTX treatment groups, respectively. Patients in the 0.5-microM and 1.0-microM groups with MCC < 300 mL at baseline showed greater improvements in MCC at 120.5% and 48%, respectively. In some patients, MCC increased up to 500% over baseline, despite a low RTX dose. Incontinence episodes decreased by 51.9% and 52.7% for the 0.5-microM and 1.0-microM RTX treatment groups, respectively. There were no long-term complications. CONCLUSION: Intravesical RTX administration, in general, is a well-tolerated new therapy for DH. This patient group was refractory to all previous oral pharmacologic therapy, yet some patients responded with significant improvement in bladder capacity and continence function shortly after RTX administration. Patients at risk for autonomic dysreflexia require careful monitoring during RTX therapy.

Title The Management of Neurogenic Bladder and Sexual Dysfunction After Spinal Cord Injury.
Date March 2002
Journal Spine
Excerpt

STUDY DESIGN: Review article. OBJECTIVES: To review the medical literature and comprehensively discuss the management of bladder and sexual dysfunction after spinal cord injury. SUMMARY OF BACKGROUND DATA: The physiologic alterations that accompany spinal cord injury can lead to significant bladder and sexual dysfunction. Fertility in men is also diminished. Without appropriate intervention, the above conditions can lead to significant morbidity and mortality. METHODS: Structured review of published reports obtained through a MED-LINE search and texts. RESULTS/CONCLUSION: With appropriate surveillance and management, morbidity and mortality from neurogenic bladder dysfunction can be successfully prevented. Current treatment interventions also facilitate the restoration of sexual function and fertility after spinal cord injury.

Title Long-term Effectiveness of Sacral Nerve Stimulation for Refractory Urge Incontinence.
Date June 2001
Journal European Urology
Excerpt

OBJECTIVES: To evaluate the long-term efficacy of sacral nerve stimulation for refractory urinary urge incontinence. STUDY DESIGN AND METHODS: Urge incontinent patients qualified for surgical implantation of a neurostimulator system after trial screening with percutaneous test stimulation. Surgical implantation of the InterStim System (Medtronic Inc., Minneapolis, Minn., USA) was performed in cases where a >50% reduction in incontinence symptoms was documented during the 3- to 7-day test stimulation period. The InterStim System consists of an implantable pulse generator, a transforamenally placed quadripolar lead, and an extension that connects these two devices for unilateral stimulation of the S3 or S4 sacral nerve. Efficacy for 96 implanted patients was based on urinary symptom changes as quantified in voiding diaries collected at baseline and annually after surgical implantation. RESULTS: As compared to baseline, the group of 96 implanted patients demonstrated significant reductions in urge incontinent symptoms at an average of 30.8+/-14.8 (range 12-60) months with respect to the number of urge incontinent episodes per day, severity of leaking, and the number of absorbent pads/diapers replaced per day due to incontinence (all p<0.0001, respectively). Gender, pretreatment variables, and age were not found to be relevant factors that affected these results. 11 of the 96 patients underwent device explant due to lack of efficacy, pain or bowel dysfunction. These data were conservatively included in the efficacy results. No permanent injuries associated with the devices or therapy were reported. CONCLUSION: Sacral nerve stimulation is an effective treatment for refractory urge incontinence with sustained long-term benefit through an average of 30.8 months.

Title Transurethral Microwave Thermotherapy of the Prostate Without Intravenous Sedation: Results of a Single United States Center Using Both Low- and High-energy Protocols. Tjuh Tumt Study Group.
Date May 2001
Journal Techniques in Urology
Excerpt

PURPOSE: Previous studies have indicated that high-energy transurethral microwave thermotherapy (TUMT) requires intravenous (IV) sedation and/or narcotics for patient tolerance. This study was performed to determine tolerability, patient acceptance, and efficacy of TUMT using both low- and high-energy protocols in a single United States university setting. MATERIALS AND METHODS: Between August 11, 1997 and October 28, 1999, 210 men (mean age 64.9 +/- 9.1 years) presenting with symptomatic benign prostatic hyperplasia (BPH) received treatment with a Prostatron TUMT using either the low-energy Prostasoft 2.O or high-energy Prostasoft 2.5 software. Each patient had digital rectal examination and prostate-specific antigen level consistent with BPH, American Urological Association symptom score > or = 15, and Qmax <15 mL/s. Each patient received TUMT with only ibuprofen 400 mg by mouth (PO), lorazepam 1.0 mg PO, and ketorolac 30 mg intramuscularly (IM) prior to TUMT. A few patients who were concerned about limited pain threshold received oxycodone 5 mg/acetaminophen 325 mg PO. Of 210 patients treated, 12-month efficacy data were available for analysis in 80 patients. RESULTS: Forty-eight men (mean age 65 +/- 9.2 years) received low-energy 2.0 software TUMT, and 32 men (mean age 65.1 +/- 9.2 years) were treated with high-energy 2.5 software. Mean prostatic volume was 44.3 +/- 23.9 mL and 60.7 +/- 26.4 mL for the 2.0 and 2.5 groups, respectively. Mean energy delivered was 108.8 +/- 50.4 kJ and 173.1 +/- 41.1 kJ for the 2.0 and 2.5 treatment groups, respectively. International Prostate Symptom Score decreased from 23 pre-TUMT to 8 post-TUMT and 21 pre-TUMT to 10 post-TUMT at 12 months in the 2.0 and 2.5 groups, respectively. Mean peak flow rate improved 31.9% from 9.1 mL/s pre-TUMT to 12.0 mL/s post-TUMT and 45.8% from 9.6 mL/s pre-TUMT to 14.0 mL/s post-TUMT at 12 months in the 2.0 and 2.5 groups, respectively. All but two patients tolerated treatment without IV sedation. One patient experienced intolerable rectal spasm, and treatment was terminated in another patient because of poorly controlled hypertension. CONCLUSIONS: Patients can be treated safely with TUMT using either low or high energy, with almost universal patient tolerance and without the need for IV sedation or narcotics, if they premedicated effectively using a PO/IM regimen. Patients experience significant relief of symptoms whether low- or high-energy TUMT is used; however, high-energy TUMT improves flow rate to a greater extent than does low-energy therapy.

Title Sacral Neuromodulation in the Treatment of Urgency-frequency Symptoms: a Multicenter Study on Efficacy and Safety.
Date June 2000
Journal The Journal of Urology
Excerpt

PURPOSE: Neuromodulation of sacral nerves has shown promising results in correcting voiding dysfunction. We report the results of a multicenter trial designed to assess the efficacy of sacral nerve neuromodulation in patients presenting with refractory urinary urgency-frequency. MATERIALS AND METHODS: A total of 51 patients from 12 centers underwent baseline assessment, including a detailed voiding diary, urodynamic evaluation and percutaneous test stimulation of the sacral nerves at S3 and/or S4. All patients enrolled in the study had undergone prior conventional treatment, such as pharmacotherapy, hydrodistention and surgical intervention, which failed. All patients demonstrated a satisfactory response to trial stimulation and were randomly divided into a stimulation group (25 patients) and a control group (26). A sacral nerve stimulation device was implanted after 6 months in the control group. Patients were followed at 1, 3 and 6 months, and at 6-month intervals for up to 2 years after implantation of a neuroprosthetic InterStim* system. dagger The study variables included the number of voids daily, volume voided per void and degree of urgency before void. RESULTS: Compared to the control group, 6-month voiding diary results demonstrated statistically significant improvements (p <0.0001) in the stimulation group with respect to the number voids daily (16.9 +/- 9.7 to 9.3 +/- 5.1), volume per void (118 +/- 74 to 226 +/- 124 ml.) and degree of urgency (rank 2.2 +/- 0.6 to 1.6 +/- 0.9). Patients in the control group showed no significant changes in voiding parameters at 6 months. Significant improvements in favor of the stimulation group were noted in various parameters with respect to water cystometry and quality of life (SF-36). At 6 months after implant, neurostimulators were turned off in the stimulation group and urinary symptoms returned to baseline values. After reactivation of stimulation sustained efficacy was documented at 12 and 24 months. CONCLUSIONS: Neuromodulation of the sacral nerves is an effective, safe therapy that successfully treats significant symptoms of refractory urgency-frequency.

Title Removal of Urolume Endoprosthesis: Experience of the North American Study Group for Detrusor-sphincter Dyssynergia Application.
Date March 2000
Journal The Journal of Urology
Excerpt

PURPOSE: We present the experience of the North American UroLume Multicenter Study Group with removal of the UroLume endoprosthesis. MATERIALS AND METHODS: A total of 160 neurologically impaired patients were enrolled in the North American UroLume Multicenter Study Group for detrusor external sphincter dyssynergia application. Analysis was performed in 2 groups of patients in which the device was removed during insertion and after implantation, respectively. RESULTS: Device retrieval was required during insertion in 21 patients (13%) mainly due to misplacement or migration in 17. Extraction was done with minimal complications and in all but 2 cases subsequent UroLume implantation was successful. Of 158 men with the device in place 31 (19.6%) required removal. In 34 procedures 44 devices were removed, mainly due to migration. Time from implantation to removal ranged from 4 days to 66 months (mean 22 months). The UroLume was removed en bloc in 20 cases and in parts or wire by wire in 19. The majority of patients had no or minimal complications after extraction. Only 2 patients had serious temporary complications, including bleeding and urethral injury, with no lasting consequences. No malignancy developed as a result of UroLume insertion. CONCLUSIONS: While there is a potential for urethral injury and bleeding, UroLume endoprosthesis removal is largely a simple procedure with minimal complications and consequences.

Title Spermatogenesis in Early and Chronic Phases of Experimental Spinal Cord Injury in the Rodent Model.
Date July 1999
Journal Journal of Andrology
Excerpt

A rodent model was used to study the degree and dynamics of potential spermatogenic alterations during both acute and chronic phases after experimental spinal cord injury (SCI). Sexually mature Sprague-Dawley rats underwent controlled impact SCI by exposure of the thoracic spine, T-10 laminectomy, and intraoperative somatosensory-evoked potential latency and amplitude. A 50 gm-cm SCI was produced in 35 experimental subjects. Sham surgery was performed on 16 control subjects through exposure of the dura without weight drop. SCI was verified by obliteration of the somatosensory-evoked potential following injury and subsequent neurologic assessment (modified hindlimb Tarlov scale) 4 weeks after injury. Flow cytometry with acridine orange as the DNA probe was used to measure potential spermatogenic alterations in testicular cell development and integrity of epididymal sperm chromatin structure between 2 and 20 weeks following SCI. Flow cytometric analysis revealed that nine of the 35 SCI animals demonstrated altered spermatogenesis; it is not clear whether these effects are specific or nonspecific stress related. These responder animals contributed to dramatic differences in relative percent testicular haploid cells (spermatids) and concurrent differences in percent diploid cells at 2, 4, 8, 12, and 16 weeks. Percentages within the three spermatid populations (round, elongating, and elongated) also differed at these time points. The sperm chromatin structure assay (SCSA) revealed significant epididymal sperm nuclear structure differences at 2, 4, and 12 weeks (P < 0.001). These findings are in concordance with our clinical observations of spermatogenesis in spinal cord injured men and suggest that significant spermatogenic deficit may occur, even in the early phase of injury.

Title Sphincteric Stent Versus External Sphincterotomy in Spinal Cord Injured Men: Prospective Randomized Multicenter Trial.
Date June 1999
Journal The Journal of Urology
Excerpt

PURPOSE: In a prospective randomized multicenter trial we compared the treatment results of conventional external sphincterotomy with those of UroLume sphincteric stent prosthesis placement in men with spinal cord injury and external detrusor-sphincter dyssynergia. MATERIALS AND METHODS: We randomized 57 men with spinal cord injury in whom urodynamics verified external detrusor-sphincter dyssynergia into 2 groups to undergo either sphincter defeating procedure. We compared the primary urodynamic parameter of maximum detrusor pressure, and secondary urodynamic parameters of bladder capacity and post-void residual urine volume in men who underwent sphincterotomy or sphincteric stent placement. Parameters were measured preoperatively, and 3, 6, 12 and 24 months postoperatively. Patients completed questionnaires regarding voiding sensation and quality of life issues at each followup visit. RESULTS: Demographic data of the 26 patients treated with sphincterotomy and the 31 treated with sphincteric stent placement were statistically similar. Preoperatively mean maximum detrusor pressure plus or minus standard deviation in sphincterotomy and stent cases was 98.3 +/- 27.6 and 95.7 +/- 27.7 cm. water, respectively (p = 0.73). At 12 months mean maximum detrusor pressure decreased to 48.9 +/- 16.4 and 52.6 +/- 31.6 cm. water in the sphincterotomy and stent groups, respectively (p = 0). Preoperatively mean bladder capacity in sphincterotomy and stent cases was 245 +/- 158 and 251 +/- 145 ml., respectively (p = 0.87). Bladder capacity did not change significantly in either treatment group throughout followup. Preoperatively mean post-void residual urine volume in the sphincterotomy and stent groups was 212 +/- 163 and 168 +/- 114 ml., respectively (p = 0.33). Residual urine volume decreased in each group at some but not all followup evaluations. The duration of hospitalization was greater for sphincterotomy than stenting (p = 0.036). Six stents required explantation. CONCLUSIONS: The UroLume stent is as effective as conventional external sphincterotomy for treating external detrusor-sphincter dyssynergia. However, sphincteric stent placement is advantageous because it involves shorter hospitalization and is potentially reversible.

Title Long-term Followup of the North American Multicenter Urolume Trial for the Treatment of External Detrusor-sphincter Dyssynergia.
Date May 1999
Journal The Journal of Urology
Excerpt

PURPOSE: We determine the long-term efficacy and safety of the UroLume stent as minimally invasive treatment for external detrusor-sphincter dyssynergia in spinal cord injured men. MATERIALS AND METHODS: A total of 160 spinal cord injured men with a mean age plus or minus standard deviation of 36.3 +/- 12.1 years (range 16 to 74) were prospectively treated with an endoprosthesis at 15 centers as part of the North American UroLume trial for external detrusor-sphincter dyssynergia. Urodynamic parameters, including voiding pressure, residual urine volume and bladder capacity, were compared before treatment and at 1, 2, 3, 4 and 5 years after treatment. RESULTS: Mean voiding pressure was 75.1 +/- 28.2 cm. water before treatment in the 160 patients, and 37.4 +/- 23.9 at year 1 in 97, 39.5 +/- 22.2 at year 2 in 84, 42.6 +/- 27.3 at year 3 in 61, 46.3 +/- 33.2 at year 4 in 57 and 44.2 +/- 28.9 cm. at year 5 in 41 after stent insertion (p <0.001). Residual urine volume decreased after stent placement and was maintained throughout the 5-year followup (p <0.001). Mean cystometric capacity remained constant from 269 +/- 155 before insertion to 337 +/- 182 ml. 5 years later (p = 0.17). Hydronephrosis and autonomic dysreflexia improved or stabilized in most patients with functioning stents. Stent explant was necessary in 24 patients (15%), of whom 4 (16.7%) had another stent implanted. CONCLUSIONS: The UroLume stent demonstrates long-term safety and efficacy for the treatment of external detrusor-sphincter dyssynergia. The outcome was similar in men with and without previous sphincterotomy.

Title Molecular Marker for Development of Interstitial Cystitis in Rat Model: Isoactin Gene Expression.
Date October 1998
Journal The Journal of Urology
Excerpt

PURPOSE: To determine whether the differential expression of bladder smooth muscle isoactin can be used as a molecular marker for the development of interstitial cystitis (IC). METHODS: Three groups of five female Sprague-Dawley rats each underwent urethral catheterization and intravesical instillation of 0.5 ml. of 0.4N HCl. One group was sacrificed one, two and four weeks after the application of HCl, and their bladders harvested for histologic examination and evaluation using Northern blot analysis of bladder smooth muscle isoactins. Five control animals were sacrificed and their bladders harvested to establish isoactin gene expression of bladder smooth muscle in the normal state. The bladders of the rats in each group were excised, immediately frozen in liquid nitrogen, pooled, then stored -70 degrees C until needed for RNA isolation. Isoactin cDNA probes have been developed, therefore isoactin specific cDNA insert fragments were isolated and insert DNA was purified by gel electrophoresis. Total cellular RNA was isolated from 1.0 gm. of bladder smooth muscle from each group. After spectrophotometric quantification, Northern Blot analysis was performed using 2% agarose-formaldehyde gels and Biotrans nylon membranes. Two complete Northern Blot series were run on a single gel and blotted to a single membrane to eliminate gel and blotting discrepancies. RESULTS: Microscopic histologic analysis revealed detrusor mastocystosis and eosinophilia as has been noted in humans with chronic interstitial cystitis. Two weeks after the intravesical application of hydrochloric acid, the relative expression of gamma-smooth muscle isoactin was noted to increase by 1.7-fold, while alpha-smooth muscle isoactin expression increased by a factor of 9. These effects were seen to stabilize four weeks after acid application. CONCLUSIONS: The intravesical application of dilute HCl in rats results in a histologic appearance which mimics that seen in humans with interstitial cystitis. The appearance of detrusor mastocytosis and eosinophilia was accompanied by a relative decrease in the expression of gamma- and a relative increase in alpha-smooth muscle isoactin gene expression. This pattern of smooth muscle isoactin expression is consistent with a more immature and possibly synthetic smooth muscle phenotype, which may be responsible for the clinical presentation of those with IC. Northern blot analysis of bladder smooth muscle cells may serve as an effective marker for the development of interstitial cystitis in humans.

Title The Invention of the Modern Uroflowmeter by Willard M. Drake, Jr at Jefferson Medical College.
Date June 1998
Journal Urology
Excerpt

The uroflowmeter is perhaps the most important and certainly the most commonly used urodynamic instrument currently employed in urologic practice. The modern uroflowmeter was invented by Willard M. Drake, Jr., in 1946 at the Jefferson Medical College. The original manuscript, entitled "The uroflometer: an aid to the study of the lower urinary tract," appeared in Journal of Urology in 1948. Drake obtained a US patent for the device, entitled "Uroflometer," in 1953. The flowmeter, originally manufactured by van Beek Industries, was more recently manufactured and distributed by Grewe Plastics. Drake is now retired and living in Nacogdoches, Texas.

Title Early Predictors of Bladder Recovery and Urodynamics After Spinal Cord Injury.
Date March 1998
Journal Neurourology and Urodynamics
Excerpt

Our purpose was to determine if intact perianal (S4-5) pin sensation (PPS) and bulbocavernosus (S2-4) reflex (BCR) shortly after spinal cord injury (SCI) are predictive of bladder function recovery. Twenty-eight SCI patients (aged 18-68 years, Frankel Classification A-D, spinal injury level C4-T12), admitted within 72 hours of injury, underwent evaluation of initial PPS and BCR. The presence of intact PPS and BCR were correlated with the patient's voiding function and urodynamic evaluation results 1 year postinjury. Of the 28 patients within 72 hours of SCI, PPS was intact in 17 (60%) and absent in 11(40%), while 15 patients (54%) demonstrated a positive BCR and 13 (46%) did not. One year after SCI, no patient with absent PPS voided unassisted, while of the 17 patients with preserved PPS, 11 (65%) were voiding spontaneously. Of these 11 patients, urodynamic evaluation revealed detrusor areflexia in 1 (9%), normal detrusor function in 2 (18%), and detrusor hyperreflexia in 8 (73%), with 3 of these 8 patients (38%) also demonstrating detrusor-sphincter dyssynergia. At 1 year postinjury, only 2 of 13 patients (15%) with an absent BCR voided spontaneously, while 9 of 15 patients (60%) with an intact BCR were able to void. Although PPS and BCR are moderately sensitive in predicting the return of spontaneous voiding, they cannot predict detrusor hyperreflexia and sphincter dyssynergia. Therefore, urodynamic study remains an essential component of initial urologic evaluation after SCI.

Title Inguinal Cystoceles: a Previously Overlooked Etiology of Prostatism in Men Without Bladder Outlet Obstruction.
Date March 1998
Journal The Journal of Urology
Excerpt

We determine whether inguinal cystoceles, a type of extraperitoneal herniation of the bladder, are responsible for symptoms consistent with prostatism in men without bladder outlet obstruction.

Title High Incidence of Occult Neurogenic Bladder Dysfunction in Neurologically Intact Patients with Thoracolumbar Spinal Injuries.
Date March 1998
Journal The Journal of Urology
Excerpt

We determine the relationship between lower urinary tract function and somatic neurological status after thoracolumbar fracture.

Title Effect of Intravesical Capsaicin and Vehicle on Bladder Integrity Control and Spinal Cord Injured Rats.
Date March 1998
Journal The Journal of Urology
Excerpt

PURPOSE: To determine the acute effect of intravesical capsaicin on bladder mucosal integrity in normal and spinal cord injured (SCI) rats. MATERIALS AND METHODS: Intravesical reagents were instilled in 5 groups of age and weight matched female rats: 1) control + normal saline solution (NSS), 2) control + ethanol (EtOH), 3) control + capsaicin/EtOH, 4) SCI + NSS, 5) SCI + capsaicin/EtOH. Intravesical instillations were performed 4 weeks after a standard T10 SCI. Intravesical capsaicin (1 mM.) was dissolved in 30% EtOH/NSS. The animals (n = 3 each group) were sacrificed at 30 minutes, 24 hours, 72 hours, and 7 days after intravesical instillation. Whole bladders were harvested, fixed in 10% buffered formalin, and paraffin embedded. Tissue blocks were blind coded and sectioned (5 microns thickness) for histopathological analysis. All sections were initially stained with hematoxylin and eosin (H & E). Specific staining for mucin carbohydrate moieties included periodic acid-Schiff (PAS) and alcian blue. Also, immunohistochemical staining for GP51 (a urinary glycoprotein) was performed. RESULTS: Control and SCI rats exhibited similar bladder mucosal histology by H & E and mucin specific stains. Instillation of saline demonstrated no effect on bladder histology, whereas instillation of intravesical capsaicin induced a profound acute effect of thinning of the epithelium, submucosal edema, and diminished presence of GP51. EtOH produced similar pathological findings, but to a lesser degree than capsaicin. Intravesical capsaicin demonstrated a similar effect in both control and SCI animals. The peak effect was seen after 30 minutes and continued for 24 hours. Partial recovery was noted after 72 hours and complete recovery was evident by 1 week. CONCLUSIONS: The control and SCI rats demonstrated a histologically similar mucosa and glycosaminoglycan layer. The effect of saline instillation on the mucosa was negligible. Intravesical capsaicin dissolved in 30% ethanol/NSS had a profound effect on the bladder urothelium submucosa that was more pronounced than that seen with the ethanol vehicle alone in normal animals.

Title Gracilis Urethral Myoplasty: Preliminary Experience Using an Autologous Urinary Sphincter for Post-prostatectomy Incontinence.
Date October 1997
Journal The Journal of Urology
Excerpt

PURPOSE: We investigated the effect of a neurovascular intact gracilis muscle urethral wrap to restore urinary continence in men with severe stress urinary incontinence after radical retropubic prostatectomy. MATERIALS AND METHODS: Three men with stress incontinence after radical retropubic prostatectomy and external beam radiation therapy for adenocarcinoma of the prostate underwent gracilis urethral myoplasty. Video urodynamic evaluation and cystourethroscopy revealed Valsalva leak point pressure of less than 40 cm. water and a damaged urinary sphincter mechanism in all 3 patients. One man underwent concomitant ileocystoplasty. RESULTS: At 6 to 24-month followup all patients reported improved continence. Mean Valsalva leak point pressure increased from 26.3 +/- 3.2 cm. water before to 83.0 +/- 32.1 cm. water after surgery. The gracilis muscle urethral wrap did not have a deleterious effect on erectile function or ambulation. Complications included 1 wound infection. CONCLUSIONS: An autologous gracilis muscle urinary neosphincter can be constructed in the bulbous urethra in a fashion similar to that of the artificial urinary sphincter with encouraging results in this preliminary series. The gracilis neosphincter may be an alternative to the artificial sphincter, especially in patients at higher risk for complications, such as after radiation and cryotherapy.

Title Gracilis Urethromyoplasty--an Autologous Urinary Sphincter for Neurologically Impaired Patients with Stress Incontinence.
Date October 1997
Journal Spinal Cord
Excerpt

PURPOSE: To investigate the effect of a neurovascularly intact gracilis muscle urethral wrap, to be used to restore urinary continence as a transposed urinary sphincter graft, in patients with neurogenic lower urinary tract dysfunction. METHODS: Five neurologically impaired men with a denervated and damaged urinary sphincter mechanisms were treated. The etiology of sphincteric insufficiency included sphincter denervation in three patients, external sphincterotomy in one, and urethral trauma due to a chronic indwelling catheter in one. All patients underwent gracilis urethromyoplasty sphincter reconstruction. Two patients also underwent concomitant ileocystoplasty and one patient ileocystostomy because of poor bladder compliance and a bladder capacity of < 200 ml. RESULTS: The gracilis urethromyoplasty functioned as a new autologous sphincter with follow-ups ranging from 6-35 months. The surgery was successful in four patients. Three of the four patients were managed with intermittent catheterization, and one managed by ileocystostomy. The fifth patient continued to require an indwelling urethral catheter. CONCLUSION: Gracilis urethromyoplasty achieves compression of the urethra using a neurovascularly intact muscle graft. The functional urethral closure, obtained from the gracilis muscle wrap, assures dryness, and permits intermittent self-catheterization. It also avoids the risks of infection, erosion, or malfunction associated with the artificial urinary sphincter. The potential exists for electrical stimulation of this muscle graft to allow volitional control of the neo-sphincter mechanism, and voluntary voiding.

Title In-vivo Whole Bladder Response to Anticholinergic and Musculotropic Agents in Spinal Cord Injured Rats.
Date July 1997
Journal The Journal of Spinal Cord Medicine
Excerpt

The purpose of this study was to compare the effect on urodynamic parameters of anticholinergic and musculotropic agents in sham injured and spinal cord injured (SCI) rats. A standard rat SCI model induced by impact trauma was employed. Cystometrograms were performed under urethane anesthesia four weeks after SCI. Bladder capacity and voiding pressure were determined at the point of micturition monitored urodynamically and visually. The effect of oxybutynin chloride (0.01-0.1 mg/kg), propantheline bromide (0.05-0.5 mg/kg) and flavoxate hydrochloride (0.1-1.0 mg/kg) were assessed independently in sham injured and SCI rats (n = 10 in each group). Bladder capacities were 0.6 +/- 0.2 and 7.1 +/- 1.6 ml in sham and SCI rats (p < 0.01), respectively. Maximal filling pressure was 17.5 +/- 5 mmHg in sham and 25 +/- 5 mmHg in SCI rats (p < 0.05). Bladder capacity increased with all three medications. Administration of oxybutynin, propantheline and flavoxate in sham rats resulted in bladder capacities of 0.88 +/- 0.3, 0.71 +/- 0.3 and 0.8 +/- 0.2 ml, respectively (p < 0.01). In SCI rats, these drugs resulted in bladder capacities of 9.8 +/- 1.1, 7.9 +/- 1.3 and 8.8 +/- 2.0 ml, respectively (p < 0.01). No significant change in maximum filling pressure occurred. We conclude that anticholinergic and musculotropic agents caused a similar increase in bladder capacity in both sham and SCI rats. Oxybutynin enhanced bladder capacity more than propantheline or flavoxate.

Title Endoluminal Ultrasonographic and Histologic Evaluation of Periurethral Collagen Injection.
Date May 1997
Journal Journal of Endourology / Endourological Society
Excerpt

To determine the acute and chronic ultrasonographic and histologic characteristics of injected glutaraldehyde cross-linked collagen in an animal model in order to enhance the therapeutic efficacy of the delivery of collagen for the treatment of urinary incontinence, three different depths of endoluminal ultrasound-guided injection (submucosal, intramuscular, periadventitial) of collagen into the urethral and bladder walls in two Yucatan mini pigs were investigated. The ultrasonographic characteristics of the injected material were examined 1, 4, 8, and 12 weeks later. A separate set of collagen injections, into the dermis and intramuscular layer of the lateral thigh of the animals, was undertaken with small-parts ultrasound guidance and follow-up. The injected tissues of the bladder, urethra, and thigh were ultrasonographically and histologically examined 3 months post-injection. Acutely injected collagen appeared hypoechoic on ultrasonography, although echogenicity increased over time. Submucosally injected collagen remained contained, forming a discrete collection of the material, whereas periadventitially injected collagen dispersed immediately. The ultrasonographic appearance and size of collagen collections correlated directly with their histologic identification and measurement. Injected collagen generated little inflammatory reaction, although infiltration by histiofibroblasts and neovascularization of the injected collagen occurred. Submucosal collagen injection resulted in superior longevity compared with intramuscular injection. From the results of our study, we hypothesize that durable success with collagen injection for the treatment of urinary incontinence is attributable to histiofibroblast infiltration of the injected collagen. When injected collagen is replaced with a hypertrophic scar, long-lasting clinical success is likely. If the injected collagen is replaced with a contracted scar, however, urethral coaptation may not persist. Endoluminal ultrasonography is helpful in ensuring the accurate submucosal location of collagen injection and in avoiding dispersion of the material and should enhance therapeutic efficacy in the treatment of urinary incontinence.

Title Bladder Autoaugmentation.
Date April 1997
Journal Techniques in Urology
Excerpt

In this article, the short history and reported results of clinical bladder autoaugmentation are reviewed. In addition, the techniques of both bladder myomyotomy and myomectomy are described in detail. Results of animal research are presented to correlate with clinical results. The applicability of autoaugmentation to those practicing general urology and future perspectives are also addressed.

Title Rectus Urethromyoplasty of Radical Prostatectomy Anastomosis Decreases Postoperative Incontinence and Anastomotic Stricture; Technique and Preliminary Results.
Date January 1997
Journal The Journal of Urology
Excerpt

PURPOSE: To investigate the effect of rectus urethromyoplasty on vesicourethral anastomosis healing during radical retropubic prostatectomy (RRP) and in an animal model. MATERIALS AND METHODS: Three groups of 10 female rats were studied. After complete urethral transection, group A animals underwent a primary urethral anastomosis, while rectus urethromyoplasty was used to reinforce the anastomosis of the animals in group B. Group C animals served as controls. All animals underwent urodynamic evaluation one month postoperatively, then were sacrificed for histological analysis. In 3 clinical subjects at the time of RRP, a 2-3 cm x 6-8 cm. strip of rectus muscle was isolated with its blood supply intact, emanating from an inferior epigastric artery pedicle. This muscular band was used to encircle the vesico-urethral anastomosis, suspending it slightly but without tension, and securing it to the pubic symphysis. RESULTS: The micturition pattern, bladder capacity, and leak point pressure of the 3 groups of animals were not significantly different. Histological examination of the rectus sling revealed viable muscle with histofibroblast, collagen, and blood vessel ingrowth from the vascular rectus muscle into the urethra. Three successful clinical rectus urethromyoplasty cases were performed with over 12 months of follow-up. CONCLUSIONS: Reinforcement of the vesico-urethral anastomosis using rectus urethromyoplasty at the time of radical prostatectomy may improve continence by increasing urethral support and mucosal coaptation. This technique may decrease the incidence of stricture formation by augmenting blood supply available for healing of the anastomosis. Rectus urethromyoplasty may be especially beneficial to patients with an increased risk of requiring adjuvant radiation therapy post-prostatectomy.

Title Total Incontinence Secondary to Sphincter Destruction After Prostate Cryotherapy for Recurrent Prostatic Carcinoma.
Date December 1996
Journal International Journal of Urology : Official Journal of the Japanese Urological Association
Excerpt

We report a case of total urinary incontinence secondary to sphincter destruction after prostate cryotherapy for recurrent prostatic carcinoma in a 64-year-old man. Periurethral collagen injection was impossible due to inadequate penetration of the injection needle, because of severe scarring and fibrotic changes of the urethra after cryotherapy.

Title Epidemiology of Current Treatment for Sexual Dysfunction in Spinal Cord Injured Men in the Usa Model Spinal Cord Injury Centers.
Date December 1996
Journal The Journal of Spinal Cord Medicine
Excerpt

This study is a prospective multicenter cooperative survey of the evaluation and treatment of erectile dysfunction in men with spinal cord injury (SCI). Uniform database questionnaires were completed prospectively by patients seeking therapy for erectile dysfunction. Eighty-five SCI men aged 17-68 years (mean age = 26 +/- 17) were enrolled. Mean duration of traumatic SCI was 3 +/- 3.2 years (Range = 0.3-18 years). The level of injury was cervical in 20 patients, thoracic in 31, lumbar in 29 and sacral in five. Patients were fully evaluated and then counseled as to their therapeutic options. Twenty-eight chose to use a vacuum erection device (VED), 26 preferred pharmacological penile injection and five used both intracorporeal therapy and VED. The remainder were managed with marriage and sexual counseling in 10 patients, three underwent penile prosthesis placement and two used topical pharmacotherapy. Four patients used other forms of treatment and in nine no therapy was recommended. Of the patients that used pharmacologic injection only, 74 percent used papaverine as a single agent, 20 percent used papaverine with phentolamine, five percent used prostaglandin E (PGE1) alone and one percent used a mixture. Patients using injection therapy report sexual intercourse a mean of 3 +/- 3.4 times per month as compared with 5 +/- 3.2 times per month in those using VED. Five intracorporeal injection patients developed priapism while two patients using the VED developed subcutaneous bleeding and one developed penile ischemia. We conclude that although a spectrum of erectile dysfunction treatment is present among SCI centers, VED and pharmacological penile injection are by far the two most popular methods of treatment and papaverine is the most common drug. The incidence of complications is small in the model centers.

Title Urologic Manifestation of Spinal Cord Sarcoidosis.
Date December 1996
Journal The Journal of Spinal Cord Medicine
Excerpt

We present the first report of neurogenic lower urinary tract dysfunction associated with neurosarcoidosis. Urodynamic findings of detrusor hyperreflexia with detrusor-sphincter dyssynergia correlate with this patient's magnetic resonance imaging (MRI) examination which found intramedullary involvement at the mid-thoracic level.

Title The Effect of Urinary Tract Reconstruction on Neurologically Impaired Women Previously Treated with an Indwelling Urethral Catheter.
Date December 1996
Journal The Journal of Urology
Excerpt

We investigated the changes in sexuality and quality of life that evolve after lower urinary tract reconstruction in neurologically impaired women previously treated with an indwelling urethral catheter.

Title The Role of Renal Scintigraphy in the Evaluation of Spinal Cord Injury Patients with Presumed Urosepsis.
Date November 1996
Journal The Journal of Urology
Excerpt

PURPOSE: We attempted to differentiate pyelonephritis, defined as upper urinary tract parenchymal infection, from fever due to other sources in patients with spinal cord injury by radioisotope renal scintigraphy. MATERIALS AND METHODS: A total of 13 consecutive spinal cord injury patients 21 to 54 years old (level of injury C4 to cauda equina) was hospitalized with urosepsis. The diagnosis was based on medical history, physical examination and laboratory evaluation, including blood, urine, sputum and wound fluid culture and sensitivity, and a 99mtechnetium glucoheptonate renal scan for pyelonephritis. Renal scan results were compared to 1 or more of several studies performed in each case, including ultrasonography, excretory urography and axial computerized tomography. RESULTS: Glucoheptonate renal scintigraphy accurately diagnosed pyelonephritis in all 7 patients with a scintigraphic B lesion. In 2 patients with a C lesion on scintigraphy, representing a cortical scar, other sources of sepsis were identified. In the 4 patients with negative renal scans pyrexia was attributed to active decubitus wound infection and osteomyelitis. Positive and negative predictive values of renal scanning were each 100%. CONCLUSIONS: Nuclear medicine renal scanning is a valuable adjunct in the evaluation of sepsis and presumed urosepsis in the spinal cord injury population.

Title Gracilis Muscle Dynamic Urethral Sphincter Myoplasty: Rat Model Experience.
Date November 1996
Journal The Journal of Urology
Excerpt

PURPOSE: Dynamic urethral sphincter myoplasty (skeletal muscle urinary sphincter reconstruction) using a neurovascularly intact gracilis muscle was investigated in a rat model. MATERIALS AND METHODS: In female Sprague-Dawley rats, a unilateral gracilis anticus muscle flap was dissected from the medial thigh, preserving the medial muscular insertion, vascular flow, and innervation. This muscle graft was used to completely encircle the urethra and was fixed in position. Urodynamic leak point pressure (LPP) and bladder volume at leakage were measured with cystometry after 1 month, using an 18 gauge catheter placed through the bladder dome with a constant infusion rate of 0.2 ml. per minute. In addition, the effect of electrical stimulation of the gracilis myoplasty (current parameters: 1 to 10 mA, 1 to 60 Hz, 0.05 to 1 msec. duration) on intravesical leak point pressure was noted during cystometry. RESULTS: The gracilis muscle measured 3.8 +/- 0.3 cm. in length, 0.5 +/- 0.1 cm. in width and 0.2 +/- 0.1 cm. in thickness. Blood flow rates to the grafted and contralateral gracilis myoplasty were similar at 43 +/- 26 and 51 +/- 30 g.cm.3, respectively (p = 0.46). The leak point pressure (LPP) of control, unstimulated gracilis myoplasty and gracilis myoplasty with electrical stimulation were 28 +/- 8, 32 +/- 12, and 85 +/- 27 mm.Hg (p < 0.01). Bladder volumes at LPP in the 3 respective groups were 0.5 +/- 0.2, 0.6 +/- 0.3 and 1.2 +/- 0.6 ml (p < 0.01). CONCLUSIONS: Gracilis myoplasty is not obstructive, as substantiated by unchanged leak point pressure and leak point capacity. Myoplasty with low current stimulation, however, significantly increased LPP and leak point capacity.

Title Urodynamics of Spinal Cord Injury.
Date September 1996
Journal The Urologic Clinics of North America
Excerpt

Historically, urologic complications have been the major source of morbidity and mortality among spinal cord injured (SCI) patients. All SCI patients should undergo urodynamic evaluation, with the initial urodynamics study done after the patient is beyond the spinal-shock phase. Management of the urinary tract in SCI individuals should be based on urodynamic principles and findings rather than on the neurologic history.

Title Comparison of Bladder Rupture Pressure After Intestinal Bladder Augmentation (ileocystoplasty) and Myomyotomy (autoaugmentation).
Date August 1996
Journal Urology
Excerpt

OBJECTIVES. To compare the risk of bladder rupture of bladder augmentation using ileocystoplasty versus that of autoaugmentation with myomyotomy in a rat model. METHODS. Bladder rupture pressure and volume of three groups of female Sprague-Dawley rats were determined by cystometry. The first group of 11 rats had undergone ileocystoplasty using a detubularized 1 -cm segment of ileum. A second group of 9 rats had undergone autoaugmentation with myomyotomy. One month after surgery the animals were studied cystometrically to determine the bladder rupture pressure, then killed. A third group, consisting of 10 nonoperated rats, was studied and served as controls. RESULTS. Nonoperated, control rat bladders were able to sustain 154 +/- 43 mm Hg pressure and 2.5 +/- 2.0 mL volume prior to bladder rupture. Conventional ileocystoplasty was noted to increase bladder capacity to 4.0 +/- 1.9 mL, but decrease rupture pressure to 111 +/- 49 mm Hg. Myomyotomy resulted in a mean bladder rupture volume of 1.2 +/- 0.4 mL, with a rupture pressure of 101 +/- 13 mm Hg. The rupture pressure after myomyotomy is significantly lower than that of the native bladder (P < 0.001), whereas the rupture volume after myomyotomy is significantly lower than either after the ileocystoplasty or with the native bladder (P < 0.001). Bladder rupture occurred at the augmented ileal bladder dome in 7 of 11 ileocystoplasty animals and at the anastomotic suture line in 4 animals. Bladder rupture occurred at the area of bladder diverticulum in all 9 myomyotomy animals. Among controls, no specific site pattern of bladder rupture was noted. CONCLUSIONS. Bladder augmentation with myomyotomy increases vulnerability to urinary extravasation, evidenced by a significantly reduced rupture pressure and bladder volume at rupture when compared to the native bladder.

Title Fascial Sling Correction of Kinked Efferent Limb in Patients with Continent Diversion and Catheterization Difficulty.
Date July 1996
Journal The Journal of Urology
Excerpt

PURPOSE: We determined the efficacy of using a rectus fascial sling to revise an angulated efferent limb in patients with continent urinary diversion and difficulty with intermittent catheterization. MATERIALS AND METHODS: Two spinal cord injured women who underwent modified Indiana pouch urinary diversion required revision of each efferent limb because of difficulty with catheterization. A strip section of anterior rectus sheath was harvested and used to fix the efferent limb in position, assuring freedom from angulation and facilitating catheterization. RESULTS: Both patients remained continent for more than 2 years postoperatively and neither had further difficulties with catheterization or required additional surgery. CONCLUSIONS: Use of the rectus fascial sling in continent urinary diversion enables fixation of the efferent limb to facilitate catheterization and enhance continence.

Title Reversible Clinical Outcome After Sphincter Stent Removal.
Date June 1996
Journal The Journal of Urology
Excerpt

PURPOSE: We determined whether the self-expanding sphincter stent, a potential alternative to conventional external sphincterotomy for the treatment of detrusor external sphincter dyssynergia, causes a permanent effect on the lower urinary tract. MATERIALS AND METHODS: Four spinal cord injured men with voiding symptoms of detrusor external sphincter dyssynergia as noted by complete urological evaluation, including a video urodynamic study, were treated with the self-expanding sphincter stent. However, the device was explanted 6 months or longer after insertion in all 4 cases due to stent migration (3) and difficulty with condom catheter urinary drainage (1). RESULTS: All stents were removed completely without damage to the urethra. Mean voiding pressure decreased from 62.5 +/- 39.4 to 20.7 +/- 6.5 cm. water after sphincter stent placement. One year after stent explantation mean voiding pressure remained unchanged from preoperative values of 58.5 +/- 21.5 cm. water. No patient had stress urinary incontinence or endoscopically apparent urethral strictures. CONCLUSIONS: The stent can be removed even after complete epithelialization and an extended interval without damage to external sphincter function or urethral stricture formation. The urinary sphincter stent is an effective, reversible treatment for patients with detrusor external sphincter dyssynergia.

Title Mixed Urinary Incontinence Secondary to Lead Poisoning.
Date June 1996
Journal The Journal of Urology
Title Erectile Response to Topical, Intraurethral and Intracorporal Pharmacotherapy in a Rat Model of Spinal Cord Injury.
Date March 1996
Journal The Journal of Spinal Cord Medicine
Excerpt

In order to compare the erectile response to topical, intraurethral and intracorporal administration of vasoactive substances in neurologically intact and spinal cord injured (SCI) rats, a standard rat model of SCI using impact trauma at the level of T10 was employed, comparing the tumescence of 24 SCI and 25 control rats. Four weeks after SCI, the effect of vasoactive substances on erectile function was evaluated. Under ketamine anesthesia, the penis was exposed and intracorporal pressure (ICP) was monitored using saline infusion cavernosometry through a 24-gauge catheter inserted into one corpus cavernosum. Changes in ICP were recorded in response to the topical and intraurethral (IU) application of minoxidil (0.1 ml, 2% solution) and 2% nitroglycerin (NTG) ointment (0.1 gm), as well as the intracorporal (IC) administration of papaverine (0.0001-0.10 mg/kg). Results indicated that the mean baseline ICP was 8 +/- 5 mmHg for SCI and 9 +/- 4 mmHg for control rats. No response to topical therapy onto the undegloved penis was noted in either SCI or control rats. IU application of minoxidil to the degloved phallus developed ICP greater than that achieved with topical minoxidil; the topical application of NTG was less effective. In SCI rats, IC papaverine injection achieved an ICP of 56.9 +/- 24.3 mmHg, whereas papaverine in control rats generated an ICP of 43.5 +/- 38.8 mmHg. A greater increase in ICP at lower doses of each agent occurred in SCI than in control rats. We conclude that only the degloved phallus responded to topical vasoactive pharmacotherapy. Although both topical and IU applications of NTG and minoxidil increase ICP, tumescence was significantly less than that achieved with IC injection of papaverine. The IU application of minoxidil demonstrated significantly greater activity than other topical therapies. SCI rats displayed a supersensitive response to all modes of pharmacologic erectile therapy.

Title Urological Symptomatology in Patients with Reflex Sympathetic Dystrophy.
Date February 1996
Journal The Journal of Urology
Excerpt

PURPOSE: We determined the effect of reflex sympathetic dystrophy on lower urinary tract function. MATERIALS AND METHODS: A total of 20 consecutive patients (16 women and 4 men) with neurologically verified reflex sympathetic dystrophy was referred for voiding symptoms, including urgency, frequency, incontinence and urinary retention. No patient had had voiding symptoms before the initial trauma that induced reflex sympathetic dystrophy. Evaluation included medical history, physical examination, video urodynamic testing and cystoscopy. RESULTS: Mean patient age was 43.4 +/- 10.2 years (range 28 to 58) and mean duration of urological symptoms was 4.9 +/- 3.6 years (range 1 to 14). Urodynamic study demonstrated a mean cystometric bladder capacity of 417 +/- 182 ml. (range 120 to 700). The urodynamic diagnoses included detrusor hyperreflexia in 8 patients, detrusor areflexia in 8, sensory urgency in 3 and detrusor hyperreflexia with detrusor-external sphincter dyssynergia in 1. In 4 women genuine stress urinary incontinence was also documented urodynamically. CONCLUSIONS: Reflex sympathetic dystrophy may have a profound effect on detrusor and sphincter function.

Title Cutaneous Ileocystostomy (a Bladder Chimney) for the Treatment of Severe Neurogenic Vesical Dysfunction.
Date January 1996
Journal Paraplegia
Excerpt

The aim of this study was to investigate the efficacy and morbidity of cutaneous ileocystostomy, as an alternative to cystectomy and ileal conduit urinary diversion, for patients with end-stage neurogenic vesical dysfunction. Three male and eight female patients, mean age 41 years (range 28-59), with a mean duration of a neuropathic bladder of 8 years (range 4-17 years) underwent evaluation for ileocystostomy urinary diversion. Indications for the procedure included a bladder capacity < or = 200 ml (10 patients), recurrent febrile urinary tract infection (nine patients), and urinary incontinence despite an indwelling urethral catheter (all eight women). Each was felt to be a poor candidate for, or refused, continent urinary diversion or bladder augmentation cystoplasty. All eight females required concomitant pubovaginal sling urethral compression to eliminate urinary leakage from a patulous, non-functional urethra. Two patients required bilateral ureteral reimplantation for grade III-IV/V reflux. Effective low-pressure urinary stomal drainage was achieved without the need for chronic catheterization in all of the patients with a mean duration of follow-up of 24 months (range 6-60 months). No patient has developed pyelonephritis since the procedure. Urethral urinary leakage was eliminated in all of the female patients, whilst vesicoureteral reflux resolved in those with reflux preoperatively.

Title Management of Sphincter Dyssynergia Using the Sphincter Stent Prosthesis in Chronically Catheterized Sci Men.
Date September 1995
Journal The Journal of Spinal Cord Medicine
Excerpt

This effort represents a subset analysis of the long-term Multicenter North American Trial of the UroLume sphincter stent prosthesis to determine the effect of the sphincter stent prosthesis in SCI men afflicted with detrusor-external sphincter dyssynergia (DESD) and chronically managed with an indwelling urinary catheter. Forty-one of 153 male patients in this study were evaluated urodynamically before and after placement of the sphincter stent prosthesis. Of the 41 patients, 34 (81 percent) suffered cervical-level injury while 10 patients (25 percent) had been treated previously with external sphincterotomy. Forty patients (98 percent) were troubled with recurrent urinary tract infections (UTI), with a mean of 4.6 +/- 3 episodes of UTI per year. Seven patients (17 percent) demonstrated hydronephrosis prior to stent placement. Follow-up ranged from six to 44 months. Voiding pressures decreased from a mean of 77 +/- 23 cmH2O preoperatively to 35 +/- 18 cmH2O at 12 months (n = 34) and 33 +/- 20 cmH2O at 24 months (n = 22) after stent insertion (p = 0.001). Post-void residual urinary volume decreased from 202 +/- 187 ml preinsertion to 64 +/- 69 ml at 24 months (p = 0.001) postinsertion. Maximum cystometric capacity remained constant at 201 +/- 144 ml preinsertion to 203 +/- 79 ml at 24 months (p = 0.75) postinsertion. No significant changes in any of the urodynamic parameters occurred after 24 months of follow-up between patients with (n = 10) and without (n = 31) previous external sphincterotomy. Neither hemorrhage requiring blood transfusion, obstructive hyperplastic epithelial overgrowth, stent encrustation or stone formation, nor soft tissue erosion occurred in any patient.(ABSTRACT TRUNCATED AT 250 WORDS)

Title Neurogenic Vesical Dysfunction.
Date September 1995
Journal The Urologic Clinics of North America
Excerpt

Women with neurogenic vesical dysfunction are prone to the development of urologic complications. These patients require diagnostic evaluation including the use of urodynamic study, imaging, and often endoscopy. These studies ultimately determine whether medical management or surgical intervention will minimize the long term risk of urologic complications. Proper definitive treatment of this patient group effectively enhances quality of life and patient satisfaction.

Title Contact Laser Vaporization Techniques for Benign Prostatic Hyperplasia.
Date September 1995
Journal Journal of Endourology / Endourological Society
Excerpt

Contact laser applications for the relief of bladder outlet obstruction caused by an enlarged prostate are different from the noncontact Nd:YAG laser methods. The noncontact techniques rely on coagulation necrosis or high power-density vaporization. The pure contact Nd:YAG laser allows cutting, coagulation, and vaporization of tissue with minimal penetration beyond the contact surface. In the contact laser prostatectomy technique, the laser probe directly touches and vaporizes the prostatic tissue. This results in immediate removal of the obstructing tissue, in a manner similar to the standard electrosurgical transurethral resection (TURP), and offers the patient the potential for decreased catheter time and a more rapid resolution of symptoms. Our initial experience suggests that the contact technique (contact laser ablation of the prostate or CLAP) may be better suited for the smaller prostate gland (i.e., less than 20-30 g). For prostates larger than 30 g, a newly described procedure known as coagulation and hemostatic resection of the prostate (CHRP) can be used. This method combines initial noncontact coagulation of the prostate with vaporization of a channel. The goal of CHRP is to allow more rapid removal of the catheter with a continued improvement in urine flow secondary to the coagulation effects. The contact laser is specifically designed to vaporize tissue such as the prostate and allows immediate observation of a TUR defect. Improvements in the delivery system and in the size of the contact laser probes have made CLAP a useful modality for the treatment of symptomatic benign prostatic hyperplasia.

Title Improved Quality of Life and Sexuality with Continent Urinary Diversion in Quadriplegic Women with Umbilical Stoma.
Date September 1995
Journal Archives of Physical Medicine and Rehabilitation
Excerpt

Quality of life issues prompted us to offer continent urinary diversion to quadriplegic women who required cystectomy for end-stage neurogenic vesical dysfunction complicated by urethral destruction as a result of chronic indwelling catheterization. Three women with spinal cord injury (SCI) and resultant quadriplegia of 5 to 15 years duration underwent continent urinary diversion. Preoperative evaluation and urodynamic studies in each showed a bladder capacity of less than 150mL, bilateral vesicoureteral reflux, recurrent febrile urinary tract infections, an incompetent urethral sphincter, and incontinence around an indwelling catheter in all three patients. Although highly motivated, these women showed minimal dexterity and were unable to perform urethral self-catheterization. Each was opposed to having an incontinent abdominal urinary stoma. The urinary reservoir was created from 30cm of detubularized right colon. The continence mechanism used an intussuscepted and imbricated ileocecal valve. The umbilicus was chosen as the urostomy site because of cosmetic appearance and ease of catheterization for a patient with minimal dexterity. Follow-up ranged from 18 to 30 months. Reservoir capacity ranged from 550 to 800mL without evidence of reflux or stomal leakage. The incidence of symptomatic autonomic dysreflexia and urinary tract infection decreased postoperatively in all patients. Of the two women who were sexually active, the frequency of activity increased from 8 to 15 episodes per month in one and 3 to 4 episodes per month in the other. Both reported improved sexual enjoyment. Body image and satisfaction with urologic management increased in all three patients. In conclusion, continent urinary diversion in selected quadriplegic patients is a reasonable alterative to incontinent intestinal urinary diversion. The umbilical stoma provides an excellent cosmetic result which patients with minimal dexterity are able to catheterize easily. Continent urinary diversion in women results in improved self-image, quality of life, and enables greater sexual satisfaction.

Title Contact Neodymium:yttrium-aluminum-garnet Laser Ablation of the External Sphincter in Spinal Cord Injured Men with Detrusor Sphincter Dyssynergia.
Date June 1995
Journal Urology
Excerpt

OBJECTIVES. The purpose of this study was to determine the efficacy and safety of contact neodymium:yttrium-aluminum-garnet (Nd:YAG) laser external sphincterotomy as an alternative treatment of detrusor-external sphincter dyssynergia (DESD). METHODS. Twenty-two spinal cord injured men with video-urodynamically verified DESD underwent external urinary sphincter ablation using the contact Nd:YAG laser. Three patients with bladder neck obstruction required concurrent contact laser bladder neck incision. Preoperative urodynamic parameters of voiding pressure, bladder capacity, and residual urine were compared with those obtained 1 year postoperatively. RESULTS. Each procedure was performed with the Nd:YAG contact laser set at 40 to 50 W, with a total accumulated energy of 23,800 to 60,000 J for each patient. The mean duration of surgery was 45 +/- 21 minutes. Bladder voiding pressure decreased from 87 +/- 23 preoperatively to 47 +/- 11 cm H2O at 12 months (P < 0.01). Residual urine volume decreased significantly, from 122 +/- 77 to 33 +/- 19 mL at 12 months (P < 0.01), and bladder capacity remained unchanged at 174 +/- 84 and 230 +/- 92 mL (P = 0.57). Three patients were found to have recurrent sphincter obstruction 1 year after laser sphincterotomy. Two patients experienced complications associated with condom catheter urinary drainage and returned to the use of an indwelling catheter. One patient experienced diminished reflex erectile function postoperatively. No patient required blood transfusion. No deleterious effects on renal function or symptoms of autonomic dysreflexia were noted. CONCLUSIONS. External urinary sphincter ablation using the contact Nd:YAG laser compares favorably with electrosurgical techniques.

Title Ddavp in the Urological Management of the Difficult Neurogenic Bladder in Spinal Cord Injury: Preliminary Report.
Date March 1995
Journal The Journal of the American Paraplegia Society
Excerpt

The purpose of this study is to determine the efficacy of desmopressin (DDAVP), a synthetic analogue of antidiuretic hormone, as an alternative therapy in the management of spinal cord injured (SCI) patients with neurogenic bladder dysfunction unresponsive to conventional therapy. Seven SCI patients (three men and four women) were treated with DDAVP after urodynamic evaluation. Despite treatment with anticholinergic agents, urodynamic evaluation demonstrated uninhibited detrusor contractions exceeding 30 cm H2O pressure at less than 300 ml cystometric capacity in all seven patients. Three patients had been managed with intermittent self-catheterization, but had socially unacceptable short intervals between catheterizations. Two women with incomplete injury were afflicted with significant nocturia (> 3 episodes/night). The remaining two patients managed with intermittent self-catheterization were troubled with nocturnal enuresis. The patients received 10 micrograms intranasal DDAVP once every 24 hours. Prior to DDAVP administration, the four patients who used DDAVP nightly experienced a median of four episodes of nocturia. After one month of DDAVP treatment, two patients had only one episode of nocturia per night and in the other two patients, nocturnal enuresis was completely eliminated. Three patients used daytime DDAVP administration at work to avoid frequent catheterization. The median period between bladder catheterizations increased from 2.5 hours before DDAVP to 6 hours while using DDAVP. Symptomatic improvement persisted during the follow-up period of 6-20 months (mean = 12). Side effects were infrequent; only one patient complained of transient headaches. Neither hyponatremia nor serum electrolyte abnormalities occurred. Our preliminary results suggest that DDAVP is safe and effective in the symptomatic management of complicated neurogenic bladder dysfunction in selected SCI patients.

Title Detrusor-myoplasty, Innervated Rectus Muscle Transposition Study, and Functional Effect on the Spinal Cord Injury Rat Model.
Date February 1995
Journal Neurourology and Urodynamics
Excerpt

The purpose of this investigation was to determine the feasibility of striated muscular augmentation of the urinary bladder (detrusor-myoplasty, DMP). Initial studies, transposition, and bladder wrap using several distinct muscle groups was attempted in laboratory rats, goats, and fresh human cadavers. The rectus abdominus muscle was found to be best suited to completely encompass the bladder with an intact neural and vascular supply. The technique was then applied in a rat model of spinal cord injury (SCI). Modified Tarlov ratings were employed to assess neurologic function 30 days after SCI. The median final neurological score of SCI rats with and without DMP was 4 and 5, respectively. Sham-operated SCI (control) rats, with and without DMP, both had normal final Tarlov scores of 12 (P < 0.05). Muscle blood flow values for the flap and the contralateral undissected rectus muscles were not significantly different (97 +/- 34 and 105 +/- 40 ml/100 g tissue/min, respectively, P = 0.47). Postoperatively, no bowel or abdominal wall functional deficits were apparent. The rotated muscular flap remained innervated and vascularized. Analysis of 24 hr micturition patterns demonstrated no differences in oral fluid intake/24hr, voided volume/24hr, and ratio of number of micturitions during the night vs. day among the four groups: (1) control (neither SCI nor DMP), (2) DMP only, (3) SCI only, and (4) SCI with DMP. Spinal cord injured rats with and without detrusor-myoplasty demonstrated a significant decrease in the number of micturitions/24hr, an increased volume per micturition, and greater largest and smallest micturition volumes (P < 0.05) when compared to controls. The micturition patterns among SCI rats with and without DMP were similar, as were non-SCI animals with and without DMP. This is the first report of the principle and technique of detrusor-myoplasty. Dissection of rats, goats, and human cadavers revealed that a vascularized and innervated rectus muscle flap can be rotated into the pelvis and wrapped around the bladder without tension. Significant loss of bladder capacity did not occur with skeletal muscle adaptation. Detrusor-myoplasty may be applicable for patients with an areflexic detrusor and non-intact sacral motor roots who are not candidates for sacral anterior root neurostimulation.

Title Intraoperative Endo-luminal Ultrasound Evaluation of Urethral Diverticula.
Date December 1994
Journal The Journal of Urology
Excerpt

The imaging accuracy of a catheter-based endo-luminal ultrasound system was compared to traditional imaging techniques for surgical treatment of urethral diverticula in 7 women and 1 man. At surgical repair the urethra was catheterized directly with a 6.2F or 9F (12.5 or 20 MHz.) catheter-based ultrasound transducer, generating a 360-degree transaxial real-time image. The endo-luminal ultrasound images were compared with preoperative voiding cystourethrography (7 patients), transvaginal ultrasound examinations (3) and double balloon urethrograms (2). Surgical diverticulectomy was then done with endo-luminal ultrasound monitoring. Intraoperatively, all diverticula were well visualized by endo-luminal ultrasound, which demonstrated improved identification of the size and orientation of urethral diverticula, sludge within the diverticula, the extent of periurethral inflammation, diverticular wall thickness, and the distance between the diverticular wall and urethral lumen. In 3 patients the urethral connections of the diverticula were exceptionally well visualized. Comparison with traditional imaging revealed 2 false-negative and 1 false-positive voiding cystourethrograms, 1 false-negative transvaginal ultrasound study and 1 false-negative double balloon urethrogram. Intraoperative monitoring of the urethra enabled precise anatomical dissection, eliminated all diverticular components, and prevented inadvertent urethral and bladder neck injury. Urethral endo-luminal ultrasound is a valuable new adjunct in the evaluation of a variety of urethral abnormalities. This new ultrasound application permits visualization of the precise size, location, orientation and characteristics of urethral diverticula and surrounding tissues. Through enhanced imaging, surgical repair is facilitated. Further application of this technique should increase the diagnostic accuracy of urethral imaging beyond radiographic techniques currently available.

Title Complications Associated with the Use of Vacuum Constriction Devices for Erectile Dysfunction in the Spinal Cord Injured Population.
Date December 1994
Journal The Journal of the American Paraplegia Society
Excerpt

The vacuum constriction device has generally been regarded as a safe and effective alternative to pharmacologic intracorporal injections or surgical placement of a penile prosthesis for the treatment of erectile dysfunction. This paper serves to exemplify the potential complications of the device when used to treat erectile dysfunction in the spinal cord-injured (SCI) population. Two cases of subcutaneous penile hemorrhage in patients using anticoagulant therapy (one treated with subcutaneous heparin and one with coumadin) and one case of penile gangrene occurred in three different SCI males. Physicians managing erectile dysfunction in SCI patients should be aware of these potential serious morbidities. The management and means of prevention of these complications are presented.

Title Latex Allergy Manifested in Urological Surgery and Care of Adult Spinal Cord Injured Patients.
Date December 1994
Journal Archives of Physical Medicine and Rehabilitation
Excerpt

This report exemplifies the cases of two male and one female spinal cord injury (SCI) patients with latex allergy, two of whom had life threatening episodes of intraoperative cardiovascular collapse. The three patients were extensively exposed to latex products as a result of urinary management programs, and two developed marked hypotension immediately upon abdominal exploration during reconstructive urological surgery. The third case represents the development in a male of latex allergy to over 12 types of latex condoms manifest as penile dermatitis. In each of these cases, allergy and immunology consultation confirmed the latex allergy. The diagnosis of latex allergy was established using both Radioallergosorbert (RAST) testing and a skin test to the latex antigen. The two patients who experienced intraoperative cardiovascular collapse required resuscitation with intravenous fluids, epinephrine, and antihistamines. Because each episode of hypotension occurred during bowel manipulation with latex gloves, they were suspected of inducing anaphylaxis. In the third patient, latex allergy was suspected after the immediate resolution of allergic symptoms upon replacing latex condom catheters with those made of silicone. This is the first report of a life-threatening reaction to latex allergy in the SCI population. Measures instituted to prevent further latex-associated morbidity included the use of medical alert bracelets, self-administration epinephrine injection kits, and nonlatex appliances, including gloves, condoms, and urethral catheters. It is recommended that precautions against the development of anaphylaxis be undertaken in SCI patients with chronic exposure to latex-containing products.

Title Flexible Cystoscopy in Spinal Cord Injury. Review Article.
Date November 1994
Journal Paraplegia
Excerpt

Endoscopy of the urinary tract remains the cornerstone of urological therapy. Over the years, continued refinement of the endoscopic instruments has permitted a progressive increase in the number and methods of their application. The development of the smaller diameter, flexible endoscopes represents the greatest advance in urological endoscopy. Their characteristics permit greater versatility with less traumatic procedures, increasing patient comfort and minimizing iatrogenic injury. Spinal cord injury (SCI) patients are a select group, which require special attention when undergoing endoscopic procedures. Often a contracted bladder or poorly controlled muscle spasms make the SCI patient difficult to endoscopic using conventional rigid instruments. Furthermore, autonomic dysreflexia is a significant concern during traumatic urinary tract instrumentation. This communication will discuss the applications of flexible cystoscopy, including novel techniques, which can be useful in SCI patients.

Title Similarity of the American Urological Association Symptom Index Among Men with Benign Prostate Hyperplasia (bph), Urethral Obstruction Not Due to Bph and Detrusor Hyperreflexia Without Outlet Obstruction.
Date October 1994
Journal British Journal of Urology
Excerpt

OBJECTIVE: To compare the specificity of the American Urological Association (AUA) Symptom Index for benign prostatic hyperplasia (BPH) versus other urodynamically verified micturitional dysfunction in men. PATIENTS AND METHODS: Fifty-seven consecutive men who had been referred for video-urodynamic evaluation of voiding symptoms were evaluated. The patients were divided into three groups: (i) BPH group (n = 24); (ii) non-BPH obstructed group (n = 20; nine bladder neck obstruction, 11 bulbous urethral stricture); and (iii) detrusor hyper-reflexia group: detrusor hyper-reflexia without outlet obstruction (n = 13). RESULTS: The mean AUA symptom score for the BPH group was 18.9 (range 7-28). The mean score for the 20 non-BPH obstructed group was 17.6 (range 4-28) and the mean score for the 13 men with detrusor hyper-reflexia was 20.5 (range 12-27). There was no statistical difference in the AUA symptom score among the three groups. CONCLUSION: The AUA Symptom Index does not specifically identify BPH or bladder outlet obstruction. The index cannot differentiate the site of obstruction as noted by the similar scores among men with BPH from those with bladder neck obstruction and urethral strictures. Moreover, The AUA Symptom Index scores are similar between men with voiding symptoms secondary to bladder dysfunction and bladder outlet obstruction.

Title Cystoscopic Autogenous Fat Injection Treatment of Vesicoureteral Reflux in Spinal Cord Injury.
Date September 1994
Journal The Journal of the American Paraplegia Society
Excerpt

The purpose of this investigation was to determine the safety and efficacy of subtrigonal, periureteral injections of autogenous fat grafts for the treatment of vesicoureteral reflux. Seven patients (12 renal units) with vesicoureteral reflux were treated with subtrigonal autogenous fat injection. Fat harvesting was obtained from abdominal and thigh subcutaneous tissue. Approximately 2 ml of fat was injected beneath each ureteral orifice with a modified 10 Fr needle through a 23.5 Fr rigid cystoscope. Two of the seven patients experienced durable (six months) resolution of reflux. In three patients, reflux resolved but recurred within three months and another developed recurrent reflux within six months. In one patient with a periureteral diverticulum, proper positioning of the needle tip for effective fat injection was not possible, resulting in persistent reflux. Two of the five patients with persistent reflux demonstrated a diminished grade of reflux on follow-up cystography. Neither complications nor ureteral obstruction have been encountered. The subtrigonal injection technique can be used with autogenous adipose tissue to treat vesicoureteral reflux. Anatomic variation may determine those patients less likely to enjoy durable results. Clinical success and reabsorption of the fat cannot be predicted or controlled at the present time. The ideal periureteral bulking agent for the treatment of vesicoureteral reflux remains to be determined.

Title Prospective Comparison of External Sphincter Prosthesis Placement and External Sphincterotomy in Men with Spinal Cord Injury.
Date September 1994
Journal Journal of Endourology / Endourological Society
Excerpt

The effectiveness and complications of the treatment of detrusor-external sphincter dyssynergia (DESD) and voiding pressure > 60 mm H2O using an endoluminal urethral sphincter prosthesis (Urolume) were compared with those of conventional external sphincterotomy in 46 men with spinal cord injury (SCI) (mean age 34 years; range 18-58 years). Twenty-six patients elected the Urolume, and 20 chose sphincterotomy. The age and level and duration of SCI were similar in the two groups. Follow-up ranged from 6 to 20 months. After prosthesis placement, voiding pressure dropped from 88 +/- 29 cm H2O to 38 +/- 22 cm H2O at 6 months (n = 23) and 35 +/- 16 cm H2O at 12 months (n = 18) (P < 0.001). The residual urine volume fell from 180 +/- 145 mL preoperatively to 85 +/- 125 mL at 12 months (P < 0.001), while the maximum cystometric capacity remained constant (P = 0.75). External sphincterotomy achieved similar statistically significant decreases in voiding pressure and residual urine volume, and bladder capacity was maintained. The preoperative and follow-up urodynamic measures were similar in the two groups. Prosthesis placement was associated with a significantly shorter operation (P = 0.001) and length of hospitalization (P = 0.01), a lower hospitalization cost (P = 0.01), and less bleeding (change in hemoglobin concentration) (P = 0.01) than external sphincterotomy. The complications of stent insertion were device migration (n = 4) and secondary bladder neck obstruction (n = 2). One patient with continuing reflux required bilateral ureteral implantation. The complications of sphincterotomy were bleeding necessitating transfusion (n = 2), recurrent obstruction (n = 2), and erectile dysfunction (n = 1). The sphincter prosthesis is as effective as sphincterotomy in the treatment of DESD, while being technically easier, less morbid, and less expensive.

Title Multicenter Trial in North America of Urolume Urinary Sphincter Prosthesis.
Date September 1994
Journal The Journal of Urology
Excerpt

We investigated the effectiveness and associated complications of treatment with an endoluminal urethral sphincter prosthesis in 153 spinal cord injury men (mean age 36 years, range 16 to 74 years) with urodynamically diagnosed detrusor-external sphincter dyssynergia. These patients were prospectively treated with a urethral sphincter stent at 15 centers in North America. Followup ranged from 2 to 33 months. Voiding pressures averaged 76 +/- 28, 42 +/- 21, 44 +/- 38, 35 +/- 18 and 32 +/- 20 cm. water, respectively, before prosthesis insertion in 153 patients and at 3 months in 123, 6 months in 114, 12 months in 98 and 24 months in 22. A significant decrease in voiding pressure was noted in the 22 patients at 24 months compared with matched preoperative data (80 +/- 25 cm. water, p = 0.03). The residual urine decreased from 181 +/- 154 ml. before insertion to 82 +/- 93 ml. at 24 months (p = 0.01). Maximum cystometric capacity remained constant, with a mean of 195 +/- 158 ml. before insertion to 248 +/- 122 ml. at 24 months (p = 0.17). No significant differences were apparent after 24 months of followup in any of the urodynamic parameters between 44 patients with and 109 without previous external sphincterotomy. Hemorrhage requiring blood transfusion, obstructive hyperplastic epithelial overgrowth and soft tissue erosion did not occur. No deleterious effects were observed on renal or erectile function. Of the patients 43 (28.1%) required 2 prostheses to bridge the external sphincter completely. Stent removal was required in 10 patients. Seven explantations were required for prosthesis migration, 1 for pain and urethral edema, 1 for inability to maintain a condom catheter, and 1 for nonepithelialization and secondary bladder neck obstruction. A total of 13 patients (8.5%) required a subsequent operation for bladder neck obstruction. Therefore, the sphincter prosthesis is an attractive modality for the treatment of external sphincter dyssynergia in patients with and without previous external sphincterotomy because of its ease of deployment and minimal associated morbidity.

Title Functional Urethral Closure with Pubovaginal Sling for Destroyed Female Urethra After Long-term Urethral Catheterization.
Date May 1994
Journal Urology
Excerpt

OBJECTIVE. To assess the pubovaginal sling as therapy for correction of the destroyed female urethra secondary to long-term indwelling Foley catheter management of neurogenic vesical dysfunction. METHODS. Fourteen women with neurologic disease and a patulous and nonfunctioning urethra underwent pubovaginal sling functional urethral closure. The purpose of the procedure is to achieve a dry perineum. Greater tension is applied to the sling suspension for urethral closure than is normally used to ensure continence for patients exhibiting intrinsic sphincter dysfunction without neurogenic vesical dysfunction. RESULTS. Two patients with adequate bladder capacity and compliance underwent only a pubovaginal sling suspension. They were subsequently managed with intermittent catheterization. In 5 patients, a sling operation in conjunction with enterocystoplasty was accomplished. In 5 patients, a sling procedure with an ileocystostomy and a cutaneous urostomy (bladder chimney) was utilized. In 2 patients, suprapubic tube drainage was established at the time of pubovaginal sling placement. All patients have achieved continence, without the need for absorbent pads, with follow-up time of six to sixty months (mean, 24 months). Abdominal wall herniation has not developed in any patient. CONCLUSIONS. The pubovaginal sling cured incontinence and has resulted in a dry perineum with few problems. The sling procedure may be superior to transabdominal or transvaginal bladder neck closure without the risk of fistula formation.

Title Prospective Comparison of Topical Minoxidil to Vacuum Constriction Device and Intracorporeal Papaverine Injection in Treatment of Erectile Dysfunction Due to Spinal Cord Injury.
Date April 1994
Journal Urology
Excerpt

OBJECTIVE. To compare the effectiveness of topically applied 2% minoxidil to that of intracorporeal injection therapy and vacuum constriction devices for the treatment of erectile dysfunction in the spinal cord injured (SCI) male. METHODS. Eighteen SCI men, aged nineteen to sixty-five years (median age, 29), and level of injury C7 to L3 (15 thoracic level) were prospectively evaluated. All patients were able to achieve only a poorly sustained reflex erection that was inadequate for satisfactory intercourse. No patient had suffered erectile dysfunction prior to his SCI. In each patient, 1 mL of a 2% minoxidil solution was applied as an aerosol spray to the glans penis. The erectile response was compared to that obtained with a vacuum constriction device (VCD) and intracorporeal papaverine injection. In each case, the subjective assessment by both the patient and the physician, as well as objective results of penile base rigidity as measured by the RigiScan DT Monitor Device, were recorded. RESULTS. Papaverine increased rigidity at the base of the penis by a median 77 percent (range, 30-100%). The VCD increased rigidity by a median 57 percent (range, 30-80%). Minoxidil induced no change in rigidity (range, 0-15%). No complications were observed for any method of inducing tumescence. CONCLUSIONS. Papaverine and VCD proved to be effective means of establishing penile erection in male SCI patients. Both subjective and objective erectile responses to minoxidil were poor. Nevertheless, the principle of topical therapy is an attractive alternative to existing modalities. Further investigation is warranted.

Title Flexible Cystoscopy During Urodynamic Evaluation of Spinal Cord-injured Patients.
Date April 1994
Journal Journal of Endourology / Endourological Society
Excerpt

Eighty-one consecutive flexible cystoscopic examinations were performed on 69 patients with spinal cord injury (SCI) at the time of their urodynamic study. The indications for cystoscopy included hematuria, recurrent urinary tract infections, symptoms of bladder outlet obstruction, the presence of an intraurethral sphincter stent requiring evaluation, neurogenic vesical dysfunction requiring endourodynamic study (cystometrogram through the working port of the flexible cystoscope), or bladder calculi. Flexible cystoscopy was accomplished in all patients, whether lying supine or seated in a wheelchair (N = 16). Only 6 of 39 patients with previous episodes of autonomic dysreflexia became hypertensive during cystoscopy. When a urodynamic catheter could not be inserted, the flexible cystoscope was particularly useful in defining the urethral anatomy or obstruction and in performing endourodynamic evaluation. The only complication was the development of febrile urinary tract infection in four patients. The flexible cystoscope is a valuable tool in the urodynamic laboratory caring for patients with SCI and is effective for use in endourodynamics, especially when patient positioning or catheter placement is difficult. The procedure is well tolerated, causes minimal stimulation leading to the development of autonomic dysreflexia, and provides accurate cystometric data.

Title Prospective Comparison of External Sphincter Balloon Dilatation and Prosthesis Placement with External Sphincterotomy in Spinal Cord Injured Men.
Date April 1994
Journal Archives of Physical Medicine and Rehabilitation
Excerpt

The purpose of our investigation was to compare external sphincterotomy, the traditional method of treatment of detrusor-external sphincter dyssynergia (DESD), with two newer methods, balloon dilatation or internal stenting of the external sphincter. Sixty-one spinal cord injured (SCI) men were prospectively evaluated. The indications for treatment were DESD and voiding pressure greater than 60 cmH2O demonstrated during video-urodynamic study. Twenty patients were treated with balloon dilatation of the external sphincter, 26 with an internal stent prosthesis, and 15 with traditional external sphincterotomy. Age and duration of SCI were similar among the three treatment groups. A significant decrease in both voiding pressure and residual urine from presurgery levels persisted during the follow-up period of 3 to 26 months (mean, 15 months) in all three groups. Bladder capacity remained constant, renal function improved or stabilized, and autonomic dysreflexia (AD) improved in all three groups. Balloon dilatation and prosthesis placement are associated with a significantly shorter length of surgery (p = 0.045), length of hospitalization (p = 0.005), decrease in hospitalization cost (p = 0.01), and decrease in hemoglobin postoperatively (p = 0.046) when compared to external sphincterotomy. Complications of stent insertion included device migration (three patients) and secondary bladder neck obstruction (two patients). In the balloon dilatation group, three recurrent sphincter obstructions, one case of bleeding requiring transfusion, and one case of bulbous urethral stricture occurred. After external sphincterotomy, two patients developed recurrent obstruction, two required blood transfusion, and 1 patient noted erectile dysfunction. Balloon dilatation and prosthesis placement both proved to be as effective as external sphincterotomy in the treatment of DESD.(ABSTRACT TRUNCATED AT 250 WORDS)

Title Detrusor-myoplasty to Restore Micturition.
Date March 1994
Journal Lancet
Title Clinical Effect of Alpha-1 Antagonism by Terazosin on External and Internal Urinary Sphincter Function.
Date February 1994
Journal The Journal of the American Paraplegia Society
Excerpt

The purpose of this investigation was to determine the effectiveness of alpha-1 blockade in the treatment of bladder outlet obstruction in the spinal cord injured (SCI) patient. We evaluated terazosin, a selective alpha-1 blocker, in 15 normotensive SCI patients. Detrusor-external sphincter dyssynergia (DESD), without obstruction of the bladder neck or prostate, was documented in all patients using video-urodynamic evaluation. Urodynamic testing was performed both before and during treatment with terazosin (5 mg nightly). Voiding pressure before and during terazosin therapy averaged 92 +/- 17 and 88 +/- 27 cm H2O, respectively (p = 0.48). After subsequent external sphincterotomy or sphincter stent placement, the voiding pressure was reduced to 38 +/- 15 cm H2O (p < 0.001). Nine other patients suffered from persistent difficulty voiding after previous sphincterotomy. Each was subsequently treated with oral terazosin. In five patients who improved with this treatment, urodynamic parameters demonstrated obstruction only at the bladder neck, with no evidence of obstruction at the level of the external sphincter. The four patients who failed to improve were documented to have an open bladder neck but obstruction at the level of the external sphincter. Our data show that alpha-1 sympathetic blockade has no effect on external sphincter function and does not significantly relieve functional obstruction caused by DESD. It was also noted that terazosin is helpful in diagnosing and treating internal sphincter (bladder neck and prostate) obstruction especially in patients who have persistent difficulty voiding after external sphincterotomy.

Title Micturition Patterns After Spinal Trauma As a Measure of Autonomic Functional Recovery.
Date January 1994
Journal The Journal of Urology
Excerpt

The purpose of these experiments was to determine whether experimental spinal trauma would result in urological dysfunction similar to that seen clinically and whether recovery of normal micturition can be correlated with motor functional recovery. A standard rat model of spinal impact trauma was employed. Neurologic evaluation included a modified 7 point hindlimb Tarlov scale applied weekly for 4 weeks after injury. Micturition measurement was accomplished by placing the animal in a metabolic cage for 24-hour periods and collecting urine on an electronic scale connected to Lotus Measure data acquisition software. All assessments were performed in a blinded fashion. Animals were categorized as normal control (N = 10), sham injured (N = 11), spinal cord injury (SCI) without (N = 11) and with locomotor recovery (N = 11). There were no differences in total micturition volume among the 4 groups, while the number of micturitions per 24 hours was significantly less for SCI without locomotor recovery (10.4 +/- 5.9) than for control (21.3 +/- 4.5). The volume per micturition was significantly greater for SCI (2.0 +/- 0.7 ml.) than for control (0.8 +/- 0.2 ml.). There were no differences among groups in the ratio of number of micturitions night/day. The SCI group had significantly greater largest and smallest micturitional volumes. Results clearly show alterations in micturition patterns induced by SCI. These were proportional to, but did not correlate fully with, the severity of injury and degree of motor recovery. Thus, recovery of a normal micturition pattern did not occur to the same extent as did motor functional recovery. This difference underscores the potential value of autonomic measures of SCI for distinguishing outcome categories after experimental SCI.

Title Neurological Manifestations of Baclofen Withdrawal.
Date December 1993
Journal The Journal of Urology
Excerpt

Baclofen is a central nervous system agent that is commonly used for the treatment of muscle spasticity in spinal cord injury patients. Acute withdrawal of this medication can induce the development of neurological symptoms, including seizure disorder, psychosis, hallucinations and visual disturbances. We report 3 cases of acute central nervous system symptoms that developed in spinal cord injury patients. Each patient had been chronically maintained on a baclofen regimen to control muscle spasticity. Symptoms developed shortly after baclofen therapy was interrupted following genitourinary surgery. It is important that urologists become familiar with the symptomatology of baclofen withdrawal, the methods of its prevention and the appropriate therapy should the syndrome develop.

Title American Urological Association Symptom Index for Women with Voiding Symptoms: Lack of Index Specificity for Benign Prostate Hyperplasia.
Date November 1993
Journal The Journal of Urology
Excerpt

An evaluation of the American Urological Association (AUA) symptom index was recently published as a valid symptom score for benign prostatic hyperplasia (BPH). To determine the specificity prospectively of the index for BPH and bladder outlet obstruction, we chose to administer the index to 38 consecutive women with voiding symptoms who were previously scheduled for video urodynamic evaluation. In each case the index was self-administered before the urodynamic study. Index determination was then repeated 1 to 4 months after the institution of therapy. Only 3 of the 38 women demonstrated true urethral obstruction. One patient exhibited urethral compression after a pubovaginal sling urethral suspension, 1 with multiple sclerosis demonstrated detrusor external sphincter dyssynergia and 1 suffered bladder neck obstruction caused by a leiomyoma. The AUA symptom index for the 35 nonobstructed women ranged from 4 to 33 (mean 17.6) Of the women 15 scored between 8 and 18, while 14 had a score of greater than 18. The mean score decreased to 9.4 after the institution of therapy, which included bladder suspension surgery, anticholinergics, timed voiding and pelvic floor exercises. Of the 3 women with bladder outlet obstruction the mean score was 22.7 before and 11.0 after therapy. A greater decrease in the AUA symptom index occurred among the obstructed group after urological therapy compared to the nonobstructed group. Our results indicate that the AUA symptom index is not specific for BPH. The index score for the women in our study rivaled the scores reported for men with BPH.

Title Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials.
Date
Journal The Journal of Sexual Medicine
Excerpt

Introduction.  Dapoxetine has been evaluated for the on-demand treatment of premature ejaculation (PE) in five phase 3 studies in various populations worldwide and has recently been approved in several countries. Aim.  To present integrated efficacy and safety data from phase 3 trials of dapoxetine. Methods.  Data were from five randomized, multicenter, double-blind, placebo-controlled studies conducted in over 25 countries. Men (N = 6,081) ≥18 years who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE; four studies required a baseline intravaginal ejaculatory latency time (IELT) of ≤2 minutes. Dapoxetine 30 and 60 mg on demand (prn; 1-3 hours before intercourse) were evaluated for either 12 or 24 weeks in four studies; one study evaluated dapoxetine 60 mg daily (qd; included in safety assessments only) or prn for 9 weeks. Main Outcome Measures.  End points included stopwatch-measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs). Results.  Average IELT (mean [standard deviation], geometric mean [standard error]) increased from baseline (across groups, 0.9 [0.49] minutes, 0.8 [1.01] minutes) to a significantly greater extent with dapoxetine 30 (3.1 [3.91] minutes, 2.0 [1.03] minutes) and 60 mg (3.6 [3.85] minutes, 2.3 [1.03] minutes) vs. placebo (1.9 [2.43] minutes, 1.3 [1.02] minutes; P < 0.001 for all) at week 12 (geometric mean fold increase, 2.5, 3.0, and 1.6, respectively). All PEP items and CGIC improved significantly with both doses of dapoxetine vs. placebo (P < 0.001 for all). The most common AEs included nausea, dizziness, and headache, and evaluation of validated instruments demonstrated no anxiety, akathisia, suicidality, or changes in mood with dapoxetine use and no discontinuation syndrome following abrupt withdrawal. Conclusions.  In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: Integrated analysis of results from five phase 3 trials. J Sex Med 2011;8:524-539.


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