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AIMS This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). METHODS The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. RESULTS Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P

Purpose/Objective: The primary objective of this FDA study is to evaluate the safety and efficacy of the ACT device (Adjustable Continence Therapy) in the treatment of female recurrent Stress Urinary Incontinence (SUI). The secondary objective is to evaluate the difficulty of placement and aspects of device adjustability. Materials and Methods: The Adjustable Continence Therapy (ACT) system (Uromedica, Inc., Plymouth, MN) consists of two silicone balloons providing urethral coaption and bladder neck support. Each balloon is attached to a titanium port buried in the labia allowing for post-operative adjustment of volume. Females with recurrent SUI with or without urethral hypermobility were evaluated at baseline and follow-up periods of 6 weeks, 3, 6, 9, 12 months and annually thereafter including urinalysis, a 3-day voiding diary, provocative pad weight test, direct visual stress test, Stamey score and validated questionnaires to assess severity of incontinence, voiding dysfunction, sexual function and quality of life. Results: During a 5 years period (2002-2007), 162 patients were implanted (mean age 67.6, range 31 - 94 years). Of these 162 patients 142, 90, 80, 56 and 31 patients completed the 1, 2, 3, 4 and 5 years follow-up respectively. One hundred and thirty five (83%) had failed at least one surgery for incontinence and 44% had failed 2 or more procedures prior to ACT implantation. Difficulty of ACT placement was rated mild in 62%, moderate in 30% and severe in 9%. Improvement in Stamey score of >1 grade was achieved in 75% (107/142) at 1 year, 76% (68/90) at 2 years, 86% (62/78) at 3 years, 93% (50/54) at 4 years and 83% (25/30) at 5 years. Dry rate (provocative pad weight 2 gms) was 51%, 62% , 76%, 76% and 76% at 1 through 5 years, and >50% improvement was achieved in 83%, 86%, 86%, 90% and 93%,respectively. IQoL improved from 37 at baseline to 71, 71, 75, 77 and 74 during the study, and optimal continence was achieved with a mean of 4 adjustments, and mean balloon volumes of 4.0 ml (1.0 - 11.5 ml). Complications including bladder perforation, erosion, migration, pain and urinary retention were reported in 25% (38/155) at 12 months, and 9% (10/109), 3% (3/91) , 6% (5/79) and 4% (3/69) respectively, and of these, the majority were mild to moderate. At 5 years, 33 patients had undergone permanent explants of both devices, 48 were lost to follow-up and 6 had died of unrelated causes. Conclusions: Five years data suggest that ACT is, a safe and effective, minimally invasive treatment for recurrent SUI, which is easy to place and adjust to optimize urinary control without impairing bladder emptying.

We present the rapid implementation of a robot-assisted surgery program by one of the largest health maintenance organizations (HMOs) in the United States.A core group of 10 urologists were offered access to a new da Vinci S surgical system. A core group of five ancillary staff was assembled and trained at an Intuitive Surgical-designated training site. An experienced robotic surgeon acted as a proctor. Data regarding patient demographics, preoperative parameters, operative times, pathologic outcomes, and EPIC-26 quality-of-life questionnaires were collected prospectively and reviewed. All procedures were recorded on digital video disc as part of a quality assurance protocol. The core group reviewed complications monthly and received feedback on surgical techniques and pathologic outcomes.A total of 100 robot-assisted laparoscopic radical prostatectomies were performed from August to October 2008. The patient demographics, preoperative parameters, operative times, and pathologic outcomes of these first 100 procedures are outlined.We demonstrate the rapid implementation of an efficient multisurgeon HMO-based robot-assisted prostatectomy program with promising initial outcomes.

Stress urinary incontinence (SUI) is a major health issue that affects millions of patients each year. Traditionally, surgical procedures such as slings or bladder neck suspension were the only options to treat this condition. In recent years, multiple minimally invasive options to treat SUI were introduced into the market. These include bulking agents, injection of stem cells into the rhabdosphincter, and adjustable continence therapy devices. These procedures are simple, minimally invasive, and well tolerated by patients. This article reviews the benefits, efficiency, side effects, and complications of these minimally invasive methods for treatment of SUI.

We determined the efficacy, safety, adjustability and technical feasibility of the adjustable continence therapy device (Uromedica, Plymouth, Minnesota) for the treatment of recurrent female stress urinary incontinence.Female patients with recurrent stress urinary incontinence were enrolled in the study and a defined set of exclusionary criteria were followed. Baseline and regular followup tests to determine eligibility, and to measure subjective and objective improvement were performed. A trocar was passed fluoroscopically and with digital vaginal guidance to the urethrovesical junction through small incisions between the labia majora and minora. The adjustable continence therapy device was delivered and the balloons were filled with isotonic contrast. The injection ports for balloon inflation were placed in a subcutaneous pocket in each labia majora. Device adjustments were performed percutaneously in the clinic postoperatively. An approved investigational device exemption Food and Drug Administration protocol was followed to record all adverse events.A total of 162 subjects underwent implantation with 1 year of data available on 140. Mean Stamey score improved by 1 grade or more in 76.4% (107 of 140) of subjects. Improvement in the mean incontinence quality of life questionnaire score was noted at 36.5 to 70.7 (p0.001). Reductions in mean Urogenital Distress Inventory (60.3 to 33.4) and Incontinence Impact Questionnaire (54.4 to 23.4) scores also occurred (p0.001). Mean provocative pad weight decreased from 49.6 to 11.2 gm (p0.001). Of the patients 52% (67 of 130) were dry at 1 year (less than 2 gm on provocative pad weight testing) and 80% (102 of 126) were improved (greater than 50% reduction on provocative pad weight testing). Complications occurred in 24.4% (38 of 156) of patients. Explantation was required in 18.3% (28 of 153) of the patients during 1 year. In terms of the complications 96.0% were considered to be mild or moderate.The Uromedica adjustable continence therapy device is an effective, simple, safe and minimally invasive treatment for recurrent female stress urinary incontinence. It can be easily adjusted percutaneously to enhance efficacy and complications are usually easily manageable. Explantation does not preclude later repeat implantation.

Nocturia is common in the elderly population and, aside from being a nuisance, it is associated with morbidity and mortality. Nocturia results from the complex interactions of several factors: changes in the urinary system and renal function with aging, the effects of sleep on renal function, changes in sleeping patterns associated with aging, and the presence of concurrent diseases and medications. Nocturia in the elderly can be caused by many conditions; a common cause is the syndrome of nocturnal polyuria. Although the pathophysiology of nocturnal polyuria remains obscure, some investigators believe that low night-time levels of antidiuretic hormone are involved. Proper management of nocturia requires identification of the specific underlying causes. This Review provides an overview of the mechanisms, evaluation and treatment of nocturia for the practicing nephrologist.

Rectourethral fistula is a potentially devastating disease for the patient and difficult management problem for the physician. We report a case of radiation and salvage cryoablation-induced rectourethral fistula for treatment of prostate cancer successfully repaired with a combined endorectal advancement flap with Alloderm® graft. The surgical technique is described in detail. The patient is now one year post-repair with no evidence of recurrence.

OBJECTIVES To demonstrate the efficacy of sacral neuromodulation and compare voiding-related health care utilization costs before and after receiving an implant. METHODS A retrospective review of patients receiving InterStim therapy (Medtronic Neurological, Minneapolis, Minn) was completed. Health care utilization was determined for the year before and the year after implantation, and included hospital and clinic visits, diagnostic and therapeutic procedures, and prescriptions. Utilization costs were derived from Medicare CPT coding and reimbursement data. Drug costs were derived from the actual pharmacy costs. Efficacy was assessed subjectively by patient-reported questionnaire and objectively by voiding diary, pad usage, and number of catheterizations. RESULTS Sixty-five patients received InterStim therapy. Outpatient visits for urinary symptoms decreased in the 12 months after implantation with a mean decrease of 2.2 visits (P

The purpose of this study is to report the outcomes of an algorithm-based multidisciplinary treatment approach to rectourethral fistula. This study is a retrospective review of a prospectively collected database at a tertiary center of all consecutive patients treated between 2003 and 2013. Thirty males (mean age 63 years) were reviewed. Prostate cancer treatment was the most common fistula etiology (97 %). Urinary drainage consisted of urethral catheter in all patients and suprapubic catheter in 14 (47 %). The rate of fecal diversion was 67 %. During a mean follow-up of 72 months, healing rate was 90 % and recurrence rate 0 %. Spontaneous healing was achieved in 14 patients (47 %): 8 (27 %) without fecal diversion and 6 (20 %) following fecal diversion. Thirteen patients (43 %) required definitive intervention. The majority of operated patients underwent transanal or transperineal flap (endorectal, dartos, or gracilis) successfully. Only 2 patients (7 %) required an abdominal approach (positive oncologic margins or non-functioning bladder). Fifteen out of the 20 patients (75 %) who underwent fecal diversion had stoma closure with an overall permanent stoma rate of 17 %. Long-term urinary incontinence was noted in 11 patients (37 %). Six patients (20 %) required permanent urinary diversion or drainage catheters. Algorithm-based treatment approach for rectourethral fistula is useful in the management of this rare condition. Selective fecal diversion is possible, and majority of patients who require definitive intervention can be treated with a transanal or transperineal approach. The rate of permanent stoma is low, but long-term urinary dysfunction is frequent.

Objectives To report on the technique of using autologous rectus fascia graft for corporeal and tunica reconstruction during placement of an inflatable penile prosthesis. Reconstructing the corpora cavernosa and closing the tunica albuginea over an inflatable penile prosthesis can be challenging when severe fibrosis is encountered. Methods Fifteen patients with severe fibrosis of the corpora or tunica were included in this study. Eight patients had severe corporeal fibrosis secondary to an infected or malfunctioned penile prosthesis that had been previously removed, and seven had severe penile curvature secondary to tunical fibrosis with concomitant erectile dysfunction. All patients underwent corporeal or tunica reconstruction using autologous rectus fascia after placement of an inflatable penile prosthesis. Postoperatively, patients were evaluated at 1, 6, 12, and 24 months. Data on patient satisfaction, graft function, and complications were recorded. Results At a mean follow-up of 18 months (range 12 to 64), augmentation of the tunica or corporeal defect using autologous rectus fascia graft was successful in all patients. The penile prostheses were functioning properly with no evidence of graft infection, erosion, or abdominal wall hematoma. Patients demonstrated good results, with return to sexual intercourse at a mean of 9 weeks postoperatively (range 8 to 10). Conclusions Use of an autologous rectus fascia graft for coverage of a tunical or corporeal defect during penile prosthesis placement in patients with corporeal or tunica fibrosis is surgically feasible, safe, and efficacious. Long-term follow-up of this reconstructive technique has demonstrated excellent clinical results with no morbidity related to the rectus fascia graft harvesting.

Purpose: We evaluated the long-term outcome, effectiveness and patient satisfaction of corporeal plication for the correction of congenital penile curvature.Materials and Methods: A total of 25 patients with congenital penile curvature were included in the study. Mean age was 39 years (range 15 to 45). Patients with Peyronie’s disease, and/or chordee associated with hypospadias or evidence of erectile dysfunction were excluded from analysis. All procedures were done on an outpatient basis using local anesthesia. The technique of corporeal plication consists of placing longitudinal plication sutures of 2-zero braided polyester on the opposing side of curvature until it is corrected during artificially induced erection. A standardized questionnaire was then completed via telephone interview to assess results as well as the patient satisfaction rate.Results: A total of 22 patients were available for evaluation. Successful results at up to 3½ years (range 1 to 42 months, mean 18) of followup were achi...

Objective To determine the long-term efficacy and complications of sacral nerve stimulation as an alternative therapy for functional unobstructive urinary retention, often considered to be psychogenic and effectively treated by clean intermittent catheterization, but for which pelvic floor dysfunction has been recognized as a possible cause. Patients and methods Twenty patients (17 women and three men, mean age 48 years) with idiopathic, unobstructive functional urinary retention and in whom other forms of therapy had failed, had a pulse generator implanted (Medtronic, Minneapolis, MN, USA) and a sacral nerve implant. Their mean duration of symptoms was 68 months; 13 patients had chronic pelvic and perineal pain associated with their obstructive voiding symptoms. All patients were managed with clean intermittent catheterization and pharmacological therapy (α-blockers) before the procedure. All patients had a percutaneous nerve evaluation before the permanent implant, which showed> 50% improvement in their symptoms. All patients were evaluated at 1, 6 12, 18 and 24 months, then yearly thereafter. The results were assessed both subjectively by patient's symptoms and objectively by checking the postvoid residual volume (PVR) and voided volume. Results Eighteen patients were able to void spontaneously with a mean increase in voided volume from 48 to 198 mL, and a significant decrease in PVR from 315 to 60 mL. Eighteen of the patients had a ≥ 50% improvement in their symptoms and said they would recommend the therapy to a friend or relative. Complications occurred in six patients. Conclusion Sacral nerve stimulation is an effective and durable new approach to functional urinary retention, with few associated complications. Test stimulation provides a valuable tool for selecting patients.

A comparative study evaluating the results of three surgical procedures for stress urinary incontinence (SUI) with urethral hypermobility. This is a retrospective study of 189 patients, evaluating the outcomes of the percutaneous needle suspension using bone anchors (PNS), abdominal suspension (AS), and pubovaginal sling (PVS). The mean follow-up was 30.5 months. In our results, the patients were divided into three groups: PNS (49), AS (34), and PVS (106). No differences were found preoperatively. Intraoperatively, PNS had the shortest operative time and lowest estimated blood loss, and it is the only outpatient procedure. However, it had the highest complication rate. PNS had the lowest satisfactory rate (16.7%). This was followed by AS (78%), PVS with cadaveric fascia (90%), and PVS with autologous fascia (94%). In conclusion, PNS is a simple outpatient procedure, but the long-term results are disappointing. Both AS and PVS gave good results. PVS was superior to AS in shorter hospitalization, early recovery and overall patient satisfaction.

Objectives. To determine the long-term efficacy and complications of sacral nerve stimulation as an alternative therapy for pelvic floor dysfunction. Pelvic floor dysfunction is a complex problem that can be refractory to current treatment modalities. Conservative therapy rarely results in a durable cure of patients, and various surgical procedures have significant side effects and less than optimal results. Methods. Sixty-four patients, 54 women and 10 men, with various forms of voiding dysfunction for whom other forms of therapy had failed underwent placement of the Medtronic Implantable Pulse Generator sacral nerve implant. The mean age was 47 years. The presenting complaint was frequency, urgency, and urge incontinence in 44 patients and chronic nonobstructive urinary retention requiring self-catheterization in 20 patients. Forty-one patients also had chronic pelvic and perineal pain associated with their voiding symptoms. The mean duration of symptoms was 69 months. All patients underwent percutaneous nerve evaluation before the permanent implant and demonstrated more than 50% improvement in their symptoms. All patients were evaluated at 1, 3, 6, 12, and 24 months, and yearly thereafter. The assessment of the voiding symptoms was done both subjectively by patient symptoms and objectively using voiding diaries recorded for 3 days. A validated verbal rating pain scale was used to evaluate pain levels. Results. Eighty percent of the patients had 50% or greater improvement in their presenting symptoms and quality of life after the procedure, with a mean follow-up of 24 months. Patients with frequency-urgency showed a reduction in the number of voids per day with a significant increase in voided volumes. Patients with urge incontinence showed a reduction in leaking episodes from 6.4 to 2.0/24 hr, with a decrease in the number of pads used from 3.5 to 1.2/day. Sixteen of 20 patients with urinary retention were able to void with a residual volume of less than 100 mL. Patients with chronic pelvic pain showed a decrease in the severity of pain from a score of 5.8 to 3.7. Complications were minimal and encountered in 18.7% of the patients. Conclusions. Sacral nerve stimulation is an effective and durable new approach to pelvic floor dysfunction with minimal complications. Test stimulation provides a valuable tool for patient selection.

Purpose: We assess the effect of sildenafil in a subgroup of patients after prostatectomy with erectile dysfunction and determine whether nerve preservation improves sildenafil response in this subgroup.Materials and Methods: Between April 1998 and January 1999, 53 patients who had undergone radical retropubic prostatectomy and were prescribed oral sildenafil were surveyed using a confidential mail questionnaire. Of the patients 21 underwent bilateral and 15 unilateral neurovascular bundle sparing procedures, while in 17 a nonnerve sparing procedure was performed. All patients received 25 to 100 mg. sildenafil in a flexible dose escalation manner. Response, satisfaction and side effects were assessed using a modified, self-administered International Index of Erectile Function questionnaire. Response was defined as erection sufficient for intercourse. Preoperative and postoperative/pretreatment erectile functions were assessed for baseline comparison in each patient, and partner overall satisfaction with s...

The objective of this study was to determine whether neonatal rat seminal vesicle mesenchyme (rSVM) can reprogram epithelial differentiation in a fully differentiated adult human bladder epithelium. For this purpose neonatal rSVM was isolated from newborn (0-day) Sprague-Dawley rats, and normal adult human bladder epithelium (hBLE) was isolated from radical cystoprostatectomy specimens to prepare rSVM+hBLE tissue recombinants in vitro. After overnight culture the tissue recombinants were grafted beneath the renal capsule of male athymic rodent hosts and allowed to grow in vivo for 6 months. As controls, rSVM and hBLE were grafted separately and allowed to grow for the same period. Tissue recombinants and control tissue grafts were harvested, and secretions were collected for biochemical studies. Tissues were fixed both for histologic as well as immunohistochemical staining. Neonatal rSVM induced normal adult human bladder urothelium to form glandular structures resembling prostate. The induced prostatic acini were filled with secretions that expressed human prostate-specific secretory proteins. These findings demonstrate that adult human urothelial cells retain a responsiveness to neonatal prostatic mesenchymal inductors. Change in urothelial histodifferentiation was associated with change in functional activity. The ability of the neonatal rat mesenchymal tissues to induce morphologic as well as biochemical changes in normal adult human urothelium provides a basis for human tissue engineering and organ reconstruction.

We review the long-term outcome of colpocystourethropexy for persistent or recurrent stress urinary incontinence after suspension procedure failure.Medical records and preoperative studies were reviewed of 60 patients (mean age 60.8 years) who had undergone colpocystourethropexy after at least 1 suspension procedure (range 1 to 8, mean 2.7). Patient responses to a standardized questionnaire regarding overall health, degree of satisfaction with colpocystourethropexy, presence or absence of leakage, and pattern and degree of leakage were elicited by telephone or mail and compared with preoperative status. Results were graded according to the degree of satisfaction and number of pads used daily. Patients with persistent incontinence were reevaluated with video urodynamic studies.Mean interval since colpocystourethropexy was 6.9 years. Successful results (greater than 80% satisfaction and the use of 1 or no pad daily) were reported by 41 patients (69%), who were significantly younger at the time of surgery than those with unsatisfactory results. In the latter group significant urge incontinence was present in 61% before the repair and in 63% postoperatively, suggesting an additional nonanatomical cause, which was confirmed by postoperative video urodynamic studies.When colpocystourethropexy was used for persistent urinary incontinence after previous surgical repair two-thirds of the patients had excellent long-term results. In patients with less satisfactory results a nonanatomical cause of urinary incontinence was a major factor.

We present 2 unusual cases of severe urgency and urge in-continence resistant to conservative therapy. Detailed work-up revealed unusual bladder pathology.

We undertook this study to evaluate the mechanism of continence in women who underwent modified radical cystectomy and creation of an ileal neobladder. Our surgical technique was modified in accordance with detailed anatomic dissection of female pelvises with attention to the innervation of the pelvic musculature and urethral sphincter. Ten women aged 41-71 years (mean 64.3 years) underwent nerve-sparing radical cystectomy and creation of an orthotopic neobladder with detubularized ileum. Videourodynamic evaluation was performed 6 months postoperatively to evaluate sphincteric and reservoir function. Seven of the ten patients were totally continent after the procedure, requiring no protective pad. Of these, one requires intermittent self-catheterization. Videourodynamic evaluation revealed a low-pressure reservoir with a mean capacity of 467 ml, and leakage did not occur during Valsalva maneuver. Three patients reported significant incontinence (more than one pad per day) after orthotopic reconstruction. These patients demonstrated intrinsic sphincteric deficiency with a low mean abdominal leak-point pressure of 48.3 cmH2O. Two of these women had stress incontinence preoperatively. In conclusion, continence can be preserved in most women after modified radical cystectomy and orthotopic bladder replacement. Success results from preservation of the intrinsic sphincteric mechanism and the creation of a low-pressure, compliant reservoir. A history of stress incontinence preoperatively appears to predispose to sphincteric weakness postoperatively.

Bladder enlargement or substitution using various segments of the gastrointestinal tract has been associated with significant metabolic and nutritional complications. Extensive research for other alternative materials, both synthetic and autologous, has revealed some difficulties including rejection, infection and stone formation. Most investigators believe that any material used for bladder augmentation must serve as a scaffold for the progressive ingrowth of all host bladder wall components, without infection or rejection. Recently, acellular matrix has been successfully utilized in experimental models for bladder substitution and appeared to satisfy many of these prerequisites.

Purpose: A neuroanatomical study was initiated to gain better insight into the continence mechanism of the isolated urethra in women.Materials and Methods: We performed a detailed gross and histological neuroanatomical study to identify the intrapelvic somatic pathway from the sacral spinal cord to the female urethral sphincter. Gross anatomical dissection was performed in 5 formalin fixed female adult pelvises by tracing the autonomic nerves from the pelvic plexus and the spinal somatic nerves from S2-S4 to the urethral sphincter. Immunohistochemical staining of urethral step sections with a neuropeptide specific antibody was performed to demonstrate the course of the periurethral somatic nerves in relation to the vaginal wall.Results: Our study demonstrated an intrapelvic somatic pathway derived from the S2, S3 and S4 sacral roots, distinct from the peripheral pudendal nerve, supplying the levator ani and the urethra. The somatic nerves travel beneath the endopelvic fascia in close relation to t...

BACKGROUND AND METHODS To assess the effect of retinoids on prostatic ductal branching morphogenesis, anterior prostates from newborn rats were cultured under serum-free conditions for 6 days in the presence of testosterone (10(-8) mM) plus 13-cis-retinoic acid (13-cis-RA), all-trans-retinoic acid (at-RA), or N-4-hydroxyphenyl-retinamide (4-HPR). Measures of morphologic complexity were computed and compared between specimens of different treatment groups. RESULTS Prostatic ductal growth and branching were inhibited in a dose-dependent fashion by both 13-cis-RA and at-RA, but not by 4-HPR. This inhibitory effect of 13-cis-RA was reversible, as the prostatic ducts resumed branching and growth after removal of retinoic acid from the culture medium. Using reverse transcription polymerase chain reaction, we then investigated the expression of nuclear receptor genes for retinoic acid. CONCLUSIONS This showed the presence of RAR-beta and RAR-gamma in the 0-day prostate, suggesting that the effects of these retinoids on ductal morphogenesis may be via these receptors.

Purpose: We evaluated the efficacy of collagen injections in the treatment of male urinary incontinence due to intrinsic sphincteric deficiency.Materials and Methods: A total of 88 men (mean age 68 years) with mild to severe intrinsic sphincter deficiency underwent a mean of 3.5 transurethral injections of collagen (mean total volume injected 25 ml.). Patients were subdivided into 2 groups based on use of more than 3 or 3 or fewer pads per day. Patient age, pad use before treatment, duration of leakage, number of injections, volume of collagen used and etiology of incontinence were compared for the 2 groups.Results: Of the patients 42 became nearly completely dry, 19 had substantial improvement but still required 1 to 3 pads per day, 14 consistently used fewer pads but still more than 3 per day and 13 showed no improvement. Most injections were performed with the patient under local anesthesia and no significant morbidity occurred.Conclusions: In select patients collagen injections appear to be ef...

Urinary incontinence continues to be a significant problem for patients after radical prostatectomy. The male perineal sling is emerging as a safe and effective treatment option for postprostatectomy stress urinary incontinence. We compare the efficacy of porcine dermal collagen and silicone mesh as the sling material.Of 36 patients with postprostatectomy stress urinary incontinence a porcine dermal collagen sling was placed in 20 and a silicone mesh sling was placed in 16. The sling was placed at the bulbar urethra and secured to 3 titanium bone screws anchored into the medial aspect of bilateral inferior pubic rami.Results at 12 months were compared. In the dermis group 9 (56%) patients were cured of incontinence (no pads daily), 5 (31%) had significant improvement (decrease of 50% or more in pads daily) and 2 (13%) had no change in symptoms. In the silicone mesh group 14 (87%) patients were cured of incontinence and 2 (13%) were significantly improved. Results showed that a previously placed artificial urinary sphincter led to poorer outcomes but a history of radiation therapy did not affect results. The most common complication was temporary urinary retention observed in 1 (5%) patient in the dermis group and 2 (12%) in the silicone mesh group.Early results demonstrate that the male sling is a safe and efficacious treatment option for postprostatectomy urinary incontinence. This study demonstrates superior outcomes with the synthetic silicone mesh sling compared to the porcine dermal collagen.

Purpose: We evaluated the safety, efficacy, failure and complications of 2 techniques of laser prostatectomy for benign prostatic hyperplasia (BPH): transurethral evaporation of the prostate (evaporation) versus visual laser ablation of the prostate (coagulation) in a randomized trial.Materials and Methods: A total of 64 consecutive patients with symptomatic BPH was randomized to undergo evaporation (32) or coagulation (32). American Urological Association symptom score, peak urinary flow rate and post-void residual urine volume were measured at baseline, and at 1, 3, 6 and 12 months. Other parameters evaluated included prostate volume by transrectal ultrasound, total laser energy per patient and per cc volume of the prostate, number of laser fibers per prostate, duration of catheterization and hospitalization, need for re-catheterization, and failure and complication rates.Results: Our main findings were that patients undergoing laser prostatectomy using the coagulation technique (visual laser ab...

Objective To investigate the relationship between the detection of prostatic intra-epithelial neoplasia (PIN) on initial prostate biopsy and subsequent invasive prostatic adenocarcinoma. Patients and methods Thirty-six men (mean age 67 years, range 52–82) with PIN underwent digital rectal examination (DRE), serum prostate-specific antigen (PSA) measurement and transrectal ultrasonography (TRUS) before the initial biopsy and documentation of PIN. They were followed up with serial PSA, TRUS and a repeat biopsy every 6 months until either invasive carcinoma was identified or 2 years had elapsed. Results The initial biopsy revealed Grade I PIN in 33%, Grade II in 22%, and Grade III in 45% of the men. The repeat biopsy showed evidence of invasive carcinoma in 21 patients (58%; Group I), while 15 (42%) showed persistence of PIN (Group II). In Group I, 19 had had high-grade PIN (Grade II/III) on initial biopsy compared with one in Group II. The findings on DRE, and age, were not significantly different between groups. TRUS revealed a hypoechoic lesion in 15/21 patients in Group I compared with 7/15 patients in Group II. There was an increase in PSA level in 18 patients in Group I (from 8.4 to 11.6 ng/mL). Conclusions PIN and invasive adenocarcinoma of the prostate were closely associated, and the likelihood for coexistence was higher in patients with high-grade PIN, increasing PSA level or positive findings on TRUS. We recommend that all patients who show high-grade PIN on prostate biopsy be followed very closely with serial PSA measurements and repeat biopsies from both the area of PIN and other areas of the prostate.

Preoperative evaluation of voiding patterns and detailed urodynamic evaluation before radical retropubic prostatectomy was carried out in an attempt to identify patients at higher risk of developing urinary incontinence postoperatively. Ninety-two men, mean age 64 years (range 54-72), who completed 1 year of follow-up after radical retropubic prostatectomy for clinically localized adenocarcinoma of the prostate were included in the study. According to the preoperative urodynamic findings, patients were divided into two main groups: group 1 (n = 64) patients with normal urodynamic findings, and group 2 (n = 28) patients with abnormal urodynamic findings. The latter group was further subdivided according to the abnormality: detrusor instability (n = 12), weak sphincter mechanism (n = 9), and detrusor and sphincter instability (n = 7). The degree and incidence of urinary incontinence were evaluated in both groups at the 1-year follow-up visit. There was a substantial difference in the incidence of urinary incontinence between the two main groups with only 2 patients with incontinence in group 1 (3%) versus 11 patients in group 2 (39%). In addition, the incidence of incontinence in group 2 differed depending on the type of abnormality: the lower incidence occurred in patients with detrusor instability (17%) and the higher incidence in patients with both detrusor and sphincter instability (71%). Identification of sphincteric and bladder dysfunction preoperatively may indicate a high risk of urinary incontinence after radical prostatectomy.

We report a series of 14 patients with 19 self-inflicted genital injuries during a period of 10 years. Of the patients 65% were psychotic and 35% were not psychotic. Repeated attempts at genital self-mutilation occurred in 31% of the cases, mainly in the psychotic group. A history of alcohol and/or drug abuse was present in 55% of the cases. Injuries varied from simple laceration of penile or scrotal skin to actual amputation of the penis or testis. The degree of injury did not differ between the psychotic and nonpsychotic patients. Surgical management and outcome varied according to the severity of the injury, the delay in presentation for treatment, and the degree of alteration in the mental status and behavior. Followup of 9 patients showed good cosmetic results with no immediate or delayed complications related to the injury. The functional results in patients with penile replantation were satisfactory. In 1 patient a urethral stricture developed that was successfully managed endoscopically. Erectile function was difficult to assess because of the marked diversity of sexual behavior in this group.

We report 2 patients with DIDMOAD syndrome (diabetes insipidus, diabetes mellitus, optic atrophy and neural deafness), with emphasis on the urological aspects and their management. Both patients underwent thorough radiological endoscopic and urodynamic evaluation, in addition to detailed evaluation of other systems involved. Each had the characteristic hyper-reflexive neurogenic bladder with sphincteric dyssynergia, which resulted in severe urinary tract dilation. One patient was diagnosed at this institution and managed conservatively with clean intermittent catheterisation and anticholinergic medication; the second patient was referred to us after several attempts at surgical correction. The presentation, details of the urological evaluation with special emphasis on the urodynamic findings, and the outcome of different means of management are discussed.

Prostaglandin E1 (PGE1) has been shown to relax the muscles of the corpora cavernosa and inhibit spontaneous activity, and clinical trials have proved its safety and effectivenes

Purpose: We evaluated the long-term results of percutaneous needle suspension using bone anchor devices for treating stress urinary incontinence in women. Materials and Methods: We retrospectively evaluated the long-term results of percutaneous bladder neck needle suspension performed at our institution. None of the women had undergone any anti-incontinence surgery before percutaneous needle suspension. A telephone survey was done for all available patients. Subjective cure was defined as no evidence of incontinence, significant improvement as 0 to 1 protective pad soaked daily and patient satisfaction with incontinence level, and failure as more than 1 pad used daily, lack of patient satisfaction or a secondary procedure required to treat stress urinary incontinence. In cases considered failures a detailed video urodynamic study was performed when possible before any secondary procedure. Results: In 1996 and 1997, 49 patients underwent percutaneous needle bladder neck suspension with bone anchors, of whom 42 (86%) were available for telephone interview. Mean patient age was 57 years (range 31 to 77) and mean followup was 29 months (range 16 to 52). As defined, subjective outcome in the 42 women was cure in 2 (5%), significant improvement in 5 (12%) and failure in 35 (83%). Of the 35 patients with treatment failure who did not undergo a secondary procedure 25 were asked to present for video urodynamics and 18 were evaluated. Urodynamics revealed demonstrable urinary incontinence, urethral hypermobility in 16 (88%), intrinsic sphincter deficiency in 1 (6%) and detrusor instability in 1 (6%). In 2 cases x-ray revealed that a bone anchor had dislodged and migrated into the pelvis. Serious osteomyelitis at the bone anchor site in 1 case required surgical debridement and 6 weeks of intravenous antibiotics. Conclusions: Percutaneous needle suspension is associated with poor long-term results in women with stress urinary incontinence. Other procedures should be considered.

Treatment of recurrent stress incontinence after a failed surgical procedure is more complicated, and repeat surgeries have higher rates of complications and limited efficacy. We determined the technical feasibility, efficacy, adjustability, and safety of adjustable continence therapy device for treatment of moderate to severe recurrent urinary incontinence after failed surgical procedure. Female patients with moderate to severe recurrent stress urinary incontinence who had at least one prior surgical procedure for incontinence were enrolled. All patients underwent percutaneous placement of adjustable continence therapy (ACT) device (Uromedica, Plymouth, Minnesota). Baseline and regular follow-up tests to determine subjective and objective improvement were performed. A total of 89 patients have undergone implantation with 1–3 years of follow-up. Data are available on 77 patients at 1 year. Of the patients, 47% were dry at 1 year and 92% improved after 1-year follow-up. Stamey score improved from 2.25 to 0.94 at 1 year (P

The understanding and management of Peyronie's disease (PD) has improved but elucidating the exact etiology of the disease has yet to be achieved. In this paper, we review the historical and clinical aspects of PD. We focus on the evolution of surgical management for PD and review recent published articles that compare popular surgical techniques such as plication and plaque incision with vein graft. These two techniques have been reported to be equivalent with respect to patient satisfaction; however, each technique has its own advantages and disadvantages.

Purpose: Retrospective evaluation of a series of patients presenting with genitourinary foreign objects. Patients and Methods: From 1997 to 2007, 11 men and 2 women were treated for a variety of foreign objects in the genitourinary tract. Medical records were reviewed for presentation, diagnosis, mental status, drug dependency, treatment, and follow-up. Results: 13 patients were seen for removal of the foreign objects or for treatment of the sequela. These objects were intentionally self-inflicted, accidentally introduced or iatrogenic in nature. Intentional objects included: safety pins, screwdriver, marbles, pen cap, pencils, straw, cocaine, stiff metal wire and part of a pizza mixer. Accidental objects included: magnets, female catheter, urinary incontinence devices and part of a Foley catheter. The iatrogenic object was a reservoir from an inflatable penile implant. Smaller noninjurious objects were retrieved cystoscopically or at the bedside; larger objects or objects associated with trauma to the urethra needed open and reconstructive operations. Conclusions: Generally thought to be self-inflicted for personal gratification, the source of genitourinary objects can also be accidental or iatrogenic. The most traumatic injuries are purposely self-inflicted and found in patients who remove the objects themselves. These patients are at higher risk of permanent urethral damage needing complex surgical treatment and follow-up.

We evaluated the long-term success rate of an abdominovaginal approach using a rotational bladder flap to repair giant vesicovaginal fistula.A total of 35 patients were included in this study. Of these patients 28 had a large vesicovaginal fistula and 7 had complete loss of the urethral floor. Fistula etiology was secondary to obstructed labor in 25 patients, the result of iatrogenic surgical injuries in 5, sling erosion in 3 and pelvic irradiation in 2. Using combined abdominal and vaginal approaches the bladder was bisected sagittally, and a bladder flap was rotated downward and medially to fill the extensive fistula defect. An additional vascularized flap was interposed in 23 patients including gracilis muscle flap in 13, omental flap in 5, peritoneal flap in 2 and Martius flap in 3.Fistulas were successfully repaired in 31 of 35 patients (88%). The remaining 4 patients underwent surgical correction with a second, more limited repair. This group included 2 patients with fistula from obstructed labor, 1 due to sling erosion and 1 due to irradiation.A combined abdominovaginal approach with the use of a generous rotational bladder flap for repair of a complex vesicovaginal fistula allowed for excellent results. There was a high success rate on the first attempt due to the excellent exposure and healthy, well vascularized tissue used for repair.

We evaluated the rabbit as an animal model for the elucidation of the neurophysiology of erection, ejaculation, and bladder function. In 24 rabbits, stimulation of the hypogastric nerves resulted in penile tumescence and contraction of the seminal vesicles and vasa deferentia. Stimulation of the sympathetic trunks induced contraction of the penis, seminal vesicles, and vasa deferentia. Cavernous nerve stimulation induced penile erection with a mean intracavernous pressure of 113 cm H2O. Pelvic nerve stimulation elicited bladder contraction, but the intraluminal pressure was low (mean, 9.6 cm H2O) in comparison with that in other species. Our results indicate that the rabbit may be an appropriate, relatively inexpensive, and readily available model for the study of ejaculatory and erectile systems in man. However, because of anatomic variations, the rabbit bladder appears to be unsuitable for comparative studies in humans.

We designed an animal model to elucidate the effect of venous leakage and arterial insufficiency on erectile function. In 10 dogs, electrodes were implanted around the cavernous nerves for electroerection and blood flow in the internal pudendal artery was recorded. Venous leakage was mimicked by inserting needles of varying gauges (30 to 16G) into the corpus cavernosum and the erectile response to neurostimulation was recorded before and after the creation of the leak. The relationship between the size and the amount of the venous leakage, the changes in the intracavernous pressure (peak and drop), and the changes in the peak and maintenance arterial blood flow were documented. Arterial blood flow was then reduced by 25 and 50 per cent by means of a screw clamp on the terminal aorta. The erectile response to neurostimulation was again determined, with the same electrical parameters, first with reduced blood flow alone, then in combination with leakage of varying size. Our results showed that minor cavernous vein leakage in the presence of normal arterial flow and a healthy sinusoidal system had a minimal effect on erectile function owing to a compensatory increase in penile blood flow. However, when reduction of arterial blood flow was superimposed on venous leakage, even of a minor degree, the erectile response to neurostimulation was markedly impaired.

We designed acute and chronic animal models to evaluate a new procedure of arterialization of the cavernous vein. In the acute study, arteriogenic impotence was induced in 6 dogs by bilateral ligation of the penile arteries just proximal to the crus of the penis. The cavernous vein and penile artery were anastomosed proximal to the site of ligation, and the pudendal vein was ligated proximally to prevent the diversion of arterial blood away from the penis. Erection was induced either by electrostimulation of the cavernous nerves or by intracavernous injection of papaverine, and the erectile response was studied before and after cavernous vein arterialization. Four dogs were followed up for two months to evaluate the long-term effects of the procedure. Shortly after arterialization of the cavernous vein, the basal flow rate in the internal pudendal artery increased dramatically to almost six times the control rate, and the erectile response to neurostimulation was approximately 85 percent of control. Selective pudendal arteriography at two months confirmed the patency of all arteriovenous anastomoses. However, scanning electron microscopy and histologic examination revealed sinusoidal damage most probably consequent to the chronically elevated arterial flow.

OBJECTIVES To compare patient-perceived outcomes of corporeal plication to plaque incision with saphenous vein grafting for the correction of Peyronie's disease. METHODS Patients with stable Peyronie's disease deemed to be good operative candidates for both tunical plication and plaque incision with saphenous vein graft were counseled on both procedures and chose which operation they would undergo. At 1 year, the records were reviewed and the patients were contacted. The variables included age, operative time, and outcome ("satisfactorily straight," loss of rigidity, loss of sensation, new use of erectile aids, ability to have intercourse, palpable nodules, erectile pain, penile shortening, and being "completely satisfied"). RESULTS Of the 67 patients, 35 underwent tunical plication and 32 underwent plaque incision with vein grafting. No differences were present in patient age between the two groups. The average operative time was shorter for the plication group (P = 0.0001). No differences were found regarding satisfactory straightness (P = 0.13), satisfaction with the operation (P = 0.71), new use of erectile aids (P = 0.06), erectile pain (P = 0.12), or subjective penile shortening (P = 0.41). Patients who underwent plaque incision with grafting were more likely to experience loss of rigidity (P = 0.03), inability to have intercourse (P = 0.05), and loss of sensation (P = 0.0045). Patients who underwent plication were more likely to experience palpable nodules (P = 0.03). CONCLUSIONS The results of our study have shown that both procedures are effective surgical options for the correction of Peyronie's disease. Plication is a simple procedure with less morbidity. Shortening is a common complaint, regardless of the type of operation done.

Objectives To report on a treatment algorithm for the management of rectal injures. Rectal injuries during laparoscopic radical prostatectomy (LRP) are rare. In the first 200 cases of LRP performed at our institution, 2 (1%) rectal injuries occurred. Our experience prompted collaboration with our colorectal surgery colleagues to develop a treatment algorithm for the management of such injuries. Methods We report on the management of rectal injuries sustained during LRP at our institution. We describe the intraoperative laparoscopic repair of a rectal tear using a 2-layer interrupted closure with absorbable suture. The conservative, nonoperative, management of a rectourethral fistula in a patient who presented after LRP is also described. Collaboration with our colorectal surgery colleagues resulted in the formulation of a treatment algorithm for intraoperative and postoperative presentations of rectal injury during LRP. The algorithm is presented. Results Of the first 200 cases of LRP at our institution 2 (1%) were complicated by rectal injury. Injuries recognized intraoperatively should be managed laparoscopically if the operating surgeon is adept at intracorporeal suturing. Small rectourethral fistulas can be managed conservatively with urinary catheterization or diversion and antibiotics as needed. Rarely, rectal injuries sustained during LRP will require fecal diversion; injuries that fail to heal despite fecal diversion require operative repair. Conclusions Rectal injuries incurred during LRP are rare but must be managed successfully to minimize morbidity. Rectal tears recognized intraoperatively can be managed laparoscopically. The development of a rectourethral fistula is a potential complication of LRP. Most fistulas can be managed conservatively with urinary catheterization or diversion. Rarely, rectal injuries that occur during LRP require fecal diversion or definitive operative repair.

OBJECTIVE To report our experience of high-dose interleukin-2 immunotherapy for patients with metastatic renal cell carcinoma (RCC) on haemodialysis. PATIENTS AND METHODS Two anephric patients with metastatic RCC on haemodialysis received interleukin-2 (600 000 IU/kg) every 8 h for a maximum of 14 doses. The patients rested for 9 days and cycles were repeated as tolerated. A nephrologist followed the patients during treatment and they received nearly daily haemodialysis. RESULTS These two cases were treated with high-dose interleukin-2 and had no unusual toxicity or adverse events. The first patient tolerated five, five, four, four and one dose of interleukin-2 over five cycles. He had a partial response to treatment with a decrease in size of a mediastinal mass, but ultimately developed progressive disease and died 32 months later. The second patient had four cycles of interleukin-2 (13, 13, 14 and nine doses). He initially maintained stable disease throughout treatment, but the disease ultimately progressed and he died 19 months later. CONCLUSIONS We recommend considering high-dose interleukin-2 immunotherapy in highly selected dialysis patients with metastatic RCC. Further study is required to determine the safety, efficacy and optimum dosing in this group.