Solifenacin significantly improves all symptoms of overactive bladder syndrome.

Overactive bladder syndrome (OAB) is a chronic condition characterised by urgency, with or without associated urge incontinence. Solifenacin succinate is a once daily, bladder selective antimuscarinic available in two doses (5 and 10 mg). The recommended dose is 5 mg once daily and can be increased to 10 mg once daily if 5 mg is well tolerated. This article presents pooled efficacy and safety data from four large, placebo-controlled, multinational phase III trials of solifenacin succinate with a total enrolment of over 2800 patients. Data from these trials show that solifenacin 5 and 10 mg once daily is significantly more effective than placebo at reducing urgency, incontinence, micturition frequency and nocturia and at increasing volume voided per micturition. Adverse events were mainly mild-to-moderate in all treatment groups. The results of these phase III trials support the use of solifenacin in the treatment of OAB.

Complications of transvaginal silicone-coated polyester synthetic mesh sling.

OBJECTIVES: To report a premarket multicenter trial to test the feasibility of a transvaginal silicone-coated polyester synthetic mesh sling in women with anatomic incontinence. METHODS: Fifty-one patients in four centers underwent transvaginal placement of a silicone-coated polyester synthetic mesh sling (American Medical Systems) during an 8-month period. Of the 51 patients, 31 were part of a prospective institutional review board-approved feasibility trial in three centers funded by American Medical Systems (group 1) and 20 underwent implantation by a single surgeon and their data were retrospectively reviewed (group 2). The studies were done concomitantly, and all slings were fixed transvaginally with bone anchors. All patients in group 1 were followed up at 4 weeks, 6 months, and 1 year (as applicable) with repeat questionnaires, physical examinations, and pad tests. RESULTS: In group 1, 20 patients completed 6 months of follow-up. Ten patients (32%) required a second surgical procedure at an average of 183 days (range 68 to 343) postoperatively. Eight patients (26%) had vaginal extrusion of the mesh, one (3%) required sling lysis, and one (3%) required sling removal because of infection. In group 2, 8 patients (40%) underwent sling removal for vaginal extrusion at a mean of 160 days (range 83 to 214). CONCLUSIONS: Transvaginally placed silicone-coated mesh slings used for the treatment of urinary incontinence demonstrated an unacceptably high vaginal extrusion rate in this study. Once identified, this study was immediately terminated, and this product was not marketed for this application in the United States.

Pubovaginal slings: a review of the technical variables.

The pubovaginal sling, reintroduced in the late 1970s by Maguire and Blaivas, has become the gold standard for managing anatomic incontinence. Newer technology, materials, surgical techniques and even new theories on the mechanism of action are evolving to further reduce the morbidity of these procedures and improve patient satisfaction. In the following review, we will highlight some of the exciting advances we have witnessed over the last year and try to put them into perspective for the reader.

Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study.

PURPOSE: More than 20 million Americans have an overactive bladder, the predominant symptoms being frequency, urgency, urge incontinence and pelvic pain. While the etiology is not completely understood, most investigators believe the causes to be many and the pelvic floor to be intimately related. Whatever the etiology, traditional therapies, including dietary manipulation, bladder drill, medications and physical therapy, are often poorly tolerated and/or ineffective. We report a prospective, multicenter clinical trial that was undertaken to determine the safety and efficacy of percutaneous peripheral afferent nerve stimulation for treatment of refractive overactive bladder and/or pelvic floor dysfunction. MATERIALS AND METHODS: A total of 53 patients with overactive bladders, in whom all traditional therapy failed, were enrolled in 1 of 5 sites within the United States. Patients received weekly percutaneous electrical stimulations via a 34 gauge needle placed near the tibial nerve 3 finger breadths above the ankle. Urodynamic studies, detailed voiding diaries, quality of life surveys, and incontinence impact questionnaires were completed before, during and after the study. RESULTS: Of the patients with a mean age of 57.4 years 89% (47 of 53) completed the 12-week study. A total of 71% of patients were classified as treatment successes by the investigators and were started on long-term treatment. On average patients noticed a 25% reduction in mean daytime and 21% reduction in mean nighttime voiding frequencies (p <0.05). Urge incontinence was reduced by an average of 35% (p <0.05). Statistically significant improvements were noted in selective pain and quality of life indexes. No significant adverse events related to treatment were noted in any patients. CONCLUSIONS: Percutaneous peripheral afferent nerve stimulation offers a safe, minimally invasive and effective treatment for managing refractive overactive bladder and/or pelvic floor dysfunction.

Cadaveric versus autologous fascia lata for the pubovaginal sling: surgical outcome and patient satisfaction.

PURPOSE: We report our initial experience with cadaveric fascia lata in pubovaginal sling procedures. MATERIALS AND METHODS: We compared 121 consecutive women who underwent a sling procedure using cadaveric fascia lata from February 1997 through June 1999 (group 1) with 46 consecutive women who underwent a sling procedure using autologous fascia lata from May 1994 through July 1997 (group 2). RESULTS: Mean followup was longer in group 2 (44 versus 12 months). A total of 104 of the 121 group 1 patients (86%) responded to the questionnaire, of whom 85% were cured of stress incontinence, 83% reported overall improvement in urinary control and 74% had no or minimal leakage not requiring pads. Median catheterization time was 9 days (range 4 to 120). Overall 89% of the women were satisfied with the results and 83% would recommend this surgery. A total of 30 of the 46 group 2 patients (65%) responded to the questionnaire, of whom 90% were cured of stress incontinence, 90% reported overall improvement in urinary control and 73% had no or minimal leakage not requiring pads. Median catheterization time was 14 days (range 6 to 180). Overall 90% of the women were satisfied with the results and 83% would recommend this surgery. CONCLUSIONS: Cadaveric fascia lata pubovaginal slings appear to be safe. Early experience suggests that cadaveric fascia lata may be considered an alternative to autologous fascia. Cadaveric and autologous fascia lata appear to have a high success rate.

Efficacy, safety and patient satisfaction outcomes of the AMS 700CX inflatable penile prosthesis: results of a long-term multicenter study. AMS 700CX Study Group.

PURPOSE: We performed a long-term multicenter study of the AMS 700CX 3-piece inflatable penile prosthesis, focusing on longevity, morbidity and patient satisfaction in men implanted up to 134 months with a median followup of 47.7 months. MATERIALS AND METHODS: We performed a large scale retrospective multicenter study in 2 phases. Phase 1 was a medical record review of 372 men who underwent implantation with the AMS 700CX penile prosthesis from 1987 to 1996 by 7 frequent penile prosthesis implanters. Phase 2 included a structured telephone interview of 207 patients by a neutral observer. RESULTS: For the 372 men in phase 1 mean device mechanical reliability plus or minus standard deviation was 92.1% + or - 3.3% after 3 and 86.2% + or - 4.6% after 5 years. Patient age was 21 to 79 years (mean 57.6 + or - 11.0) at implantation. The etiology of erectile dysfunction was vascular in 27.7% of the cases, Peyronie's disease in 16.9%, diabetes mellitus in 12.9% and radical surgery in 11.6%. Of the men 55.6% received previous treatment for erectile dysfunction. Postoperative infection and device malfunction developed in 3.2% and 17.5% of the cases, respectively. Of the 207 men interviewed in phase 2, 86% still had an AMS 700CX penile prosthesis implanted, including 87.1% with erection suitable for coitus. Currently 79% of those with a device use it at least twice monthly and 88.2% would recommend an implant to a relative or friend. CONCLUSIONS: The AMS 700CX penile implant produced suitable erection and excellent patient satisfaction at long-term followup in the majority of men. Implant reliability is excellent and postoperative morbidity is low.

Modified Pereyra bladder neck suspension in patients with intrinsic sphincter deficiency and bladder neck hypermobility: patient satisfaction with a mean follow-up of 4 years.

OBJECTIVES: To determine the long-term success rate for the modified Pereyra bladder neck suspension and to identify preoperative characteristics that create differences in surgical outcome. We attempted retrospectively to separate those patients with what we now recognize was significant intrinsic sphincter deficiency (ISD) before routine use of Valsalva leak point pressures (VLPPs) was available. METHODS: The charts and videourodynamic reports of 208 patients who underwent a modified Pereyra bladder neck suspension from June 1988 to June 1996 were reviewed, and survey questionnaires were mailed to all patients. All videourodynamic study reports and charts were reviewed to identify those with what we now recognize was significant ISD and compare them with a group that we believed had more pure descent problems. RESULTS: A total of 135 patients or 65% of the population responded. The mean time after surgery was 4.14 years. At the follow-up survey, 14% reported no leakage at all, 42% reported very little or mild leakage, 38% reported moderate leakage, and 6% reported severe leakage. Fifty-three percent of patients continued to wear pads. Seventy-nine percent reported improvement in their leakage compared with the preoperative state, and 69% were satisfied with the results. When patients with preoperative ISD were compared with patients with pure bladder neck hypermobility, the ISD group had more leakage and less improvement after surgery than patients with bladder neck hypermobility. CONCLUSIONS: With an average follow-up of greater than 4 years, most women continued to leak with symptoms of stress urinary incontinence. Even though 79% reported improvement over their preoperative condition and 69% were satisfied, the results were disappointing. Patients with significant ISD had a worse outcome (2.6% dry) than patients with pure bladder neck hypermobility (20% dry). Given the above data, significant ISD is a contraindication for a modified Pereyra transvaginal needle suspension, and these data cast further doubt on the ability of the modified Pereyra needle suspension to consistently cure even anatomic incontinence.

Efficacy and safety of transurethral alprostadil in patients with erectile dysfunction following radical prostatectomy.

PURPOSE: A retrospective analysis of the MUSE clinical trial was performed to evaluate the efficacy and safety of transurethral alprostadil in patients with erectile dysfunction after radical prostatectomy. MATERIALS AND METHODS: Patients received doses of transurethral alprostadil in the clinic and those for whom a suitable dose was determined were treated at home with active drug or placebo for 3 months. Patients had undergone radical prostatectomy no less than 3 months before study entry. RESULTS: Of the 384 patients in whom radical prostatectomy was identified as a cause of erectile dysfunction 70.3% had an erection believed sufficient for intercourse in the clinic and 57.1% on active medication had sexual intercourse at least once at home. The product of clinic and home success rates (70.3 x 57.1%) was an overall success rate (the likelihood of active treatment to lead to intercourse at home) of 40.1%. The frequency of most adverse effects of radical prostatectomy was comparable to that of other organic etiologies of erectile dysfunction (1,127 patients). The percentage of patients with hypotension in the clinic was lower after radical prostatectomy compared to other erectile dysfunction etiologies (0.8 versus 4.2%, p < 0.001) but the percentage of patients with urethral pain/burning was higher (18.3 versus 10.4%, p = 0.027). No urinary tract infection, fibrosis or priapism occurred in the post-radical prostatectomy patients. CONCLUSIONS: Transurethral alprostadil is a well tolerated and efficacious method of treating erectile dysfunction after radical prostatectomy, although psychological changes associated with cancer and surgery may limit home response. The severe neurovascular deficit associated with prostatectomy neither limits the efficacy of transurethral alprostadil nor increases the risks.

Mechanical reliability, surgical complications, and patient and partner satisfaction of the modern three-piece inflatable penile prosthesis.

OBJECTIVES: The modern three-piece inflatable penile prosthesis (IPP) has undergone multiple revisions since its introduction in 1973. We reviewed devices placed since the last major revision by American Medical Systems (AMS) in 1987. METHODS: A retrospective chart review was refined with data from an independent patient and partner survey. RESULTS: Two hundred twelve consecutive penile prosthetic devices placed by a single surgeon over an 8-year period are reviewed. One hundred sixty-nine of the devices were three-piece inflatables with 146 being primary implants. The average device has been in place 36.5 months (range 9 to 102). The infection rate in 146 primary three-piece devices was 2.1%. The infection rate in 46 secondary implants or revisions was 6.5%, excluding seven salvage attempts. Mechanical failure in 122 primary AMS devices placed was 4.1%. Mechanical failure in 24 Mentor devices was 4.2% if one discounts connector failures that were revised in 1990. A surgical complication and revision rate of 1.4% was noted in the 146 primary implants. An independent telephone survey achieved a 57% and 24% response rate in patients and partners with three-piece devices placed. In the group of 86 patients with a primary three-piece device placed and complete follow-up, the probability of having a normally functioning device placed in a single operative procedure was 90.6% at 3 years. On a 1 to 10 scale looking at all primary devices, secondary devices, revisions, and infections, the average and median satisfaction rate was as follows: 8.2, 8.5; 8.4, 9.0; 7.7, 7.75 for the Ultrex patients, CX 700 and Mentor patients, and all partners, respectively. CONCLUSIONS: The modern three-piece IPP is an excellent surgical option offering a very safe, reliable return to sexual activity for our patients.

Osteitis pubis after periurethral collagen injection.

Periurethral collagen injection is a relatively new procedure to treat stress incontinence. Until now, complications and side effects have been minor and transient. We will present the first reported case of osteitis pubis after periurethral collagen injection.

Pubovaginal slings using fascia lata for the treatment of intrinsic sphincter deficiency.

PURPOSE: Various materials and techniques have been used to construct a pubovaginal sling. We believe that fascia lata has several advantages and report our experience. MATERIALS AND METHODS: A total of 32 female patients with urodynamically proved intrinsic sphincter deficiency underwent a pubovaginal sling procedure using fascia lata. An unscarred fascial strip 24 to 28 x 2 cm. was attached to itself over a 3 to 4 cm. bridge of abdominal wall fascia. Results were tabulated by chart review and an independent patient survey. RESULTS: Chart review revealed that 28 of 32 patients (87%) required no pads, and 3 improved and 1 did not. An independent patient survey revealed that 70% of patients (21 of 30) required no pads, 20% required 1 to 3 small pads and 10% required more than 3 small pads per day. Of the patients 80% would undergo the procedure again. CONCLUSIONS: Excellent results can be obtained with fascia lata for the treatment of intrinsic sphincter deficiency. A long, wide strip of fascia attached to itself allows for precise tensioning and good urethral closure, and minimizes the risk of obstruction.

Pubovaginal slings: past, present and future.

Renewed interest in the pubovaginal sling procedure for stress urinary incontinence has occurred in response to recent reports of poor durability and inconsistent efficacy associated with simple cystourethropexy. Many of the failures are felt to represent patients with an unrecognized component of intrinsic sphincteric deficiency. Historically slings have a favourable cure rate, but have been perceived as having unacceptably high rates of prolonged urinary retention and secondary detrusor instability. This article reviews the preoperative evaluation and indications for pubovaginal slings, describes the evolution of the current techniques, and discusses choice of sling material, surgical approach, results and complications. It is hoped that this review will stimulate interest in this versatile but technically challenging procedure.

Back-pressure testing to prevent autoinflation of penile prosthetic devices.

Autoinflation of a penile prosthetic device can be a frustrating experience for the patient and surgeon alike. Although there are many causes of autoinflation, elevated reservoir pressure at the time of surgical placement is one of the more common etiologies. We describe a simple, quick technique to quantitate reservoir pressures and volume, preventing pressures that could lead to autoinflation.

Endocrine screening for sexual dysfunction using free testosterone determinations.

PURPOSE: Controversy exists concerning the need for routine endocrine screening in impotent men. Debate also continues as to what hormonal studies are necessary, the role of the free fraction of testosterone and whether a history of decreased libido or testicular atrophy can predict these endocrinopathies. MATERIALS AND METHODS: We reviewed 508 consecutive men who presented with sexual dysfunction within a 22-month period. Testosterone data were available for 268 patients (53%) and prolactin data were available for 170 (33%). RESULTS: Hypogonadism, defined as 2 abnormal total testosterone levels, was found in 42 of our 268 patients (15.6%). A history of decreased libido by patient questionnaire and/or testicular atrophy on physical examination could not predict these cases. A normal free fraction of testosterone saved further unnecessary endocrine evaluation in 50% of patients with hypogonadism. Hypoprolactinemia was noted in 3 of 170 patients (1.8%). CONCLUSIONS: Routine endocrine screening remains a necessary part of the evaluation for sexual dysfunction. A history of decreased libido and/or testicular atrophy on physical examination cannot predict hypogonadism. Measurement of free fraction of testosterone will further lessen unnecessary endocrine evaluations by 50% and should become standard practice in screening for hypogonadism. Prolactin levels are necessary only in patients with hypogonadism and/or a history of decreased libido.

Timing of penile color flow duplex ultrasonography using a triple drug mixture.

Duplex ultrasonography is an accepted method to assess noninvasively arterial inflow to the penis. Optimal pharmacological agents as well as timing of the scan and stimulation during the scan continue to be debated. In an effort to achieve a more complete smooth muscle relaxation and capture what we perceived was a wide variation in interval to maximum arterial velocity, we revised our duplex protocol in January 1991. We report on 280 consecutive patients evaluated in this manner. Patients received 0.25 or 0.5 cc of a triple drug mixture containing 22.5 mg./cc papaverine, 0.83 mg./cc phentolamine and 8.33 micrograms/cc prostaglandin E1. Scans were performed at 0, 5, 15 and 30 minutes after injection in all patients. Any patient not having a full erection at 15 minutes performed private self-stimulation while in the standing position for at least 5 minutes before the 30-minute scan. If we conservatively define normal arterial inflow as a peak Doppler velocity of 25 cm. per second or greater in the best artery, only 35% of our patients achieved this velocity at 5 minutes. Of the remainder 26% and 22% did not reach normal velocity values until 15 and 30 minutes, respectively, after the injection. By delaying initial measurements of velocity until 5 minutes, could the highest inflow velocity be missed and patients diagnosed incorrectly? The group at risk would be those who had good tumescence at 5 minutes and who had presumably already decreased the inflow velocities. Of the 280 patients 74 (26%) had greater than 10% tumescence at 5 minutes. Only 6 of these 74 patients did not reach velocities of 25 cm. per second or more in the best artery at some time during their study. In conclusion, our study clearly supports delaying the initial scan until 5 minutes, since only 6 of our 280 patients (2.1%) may have been incorrectly diagnosed. The study also strongly argues for additional scans until 30 minutes and self-stimulation when necessary.

Correlation of the cystoscopic appearance and functional integrity of the female urethral sphincteric mechanism.

OBJECTIVES: Urologists in the past, and many today, rely on the cystoscopic appearance of the female urethra as a guide to its functional integrity. To assess the accuracy of this approach better, we compared the cystoscopic appearance of the bladder neck and proximal urethra to the functional integrity of this mechanism during videourodynamic studies. METHODS: One hundred consecutive videourodynamic studies were reviewed on female patients with more complex types of urinary incontinence. Reports of their cystoscopic examinations were reviewed and results compared. RESULTS: Significant dysfunction of the intrinsic mechanism was noted in 36% of the patients (26% moderate dysfunction and 10% severe dysfunction) on video studies. Cystoscopy underestimated these deficits 74% and 44% of the time, respectively, in the moderate and severe dysfunction groups. CONCLUSIONS: We conclude that the cystoscopic appearance of the bladder neck proximal urethra cannot predict the functional integrity of this mechanism.

Oral terbutaline for the treatment of priapism.

The widespread use of penile injections in the management of erectile dysfunction has led to an increased incidence of priapism. It has been suggested that terbutaline, a beta-agonist, might be beneficial in treating priapism in this setting. We randomized 24 patients with prolonged erections to a prospective, double-blind, placebo-controlled trial. We did not find any benefit of oral terbutaline over placebo in these patients.

Experience with triple-drug therapy in a pharmacological erection program.

A group of 170 impotent men achieved usable erections during a 26-month period with a combination of papaverine, phentolamine and prostaglandin E1 (triple-drug therapy) injected intracorporeally. Of the patients 146 elected to enter a pharmacological erection program using this combination. Patient age ranged from 24 to 85 years and the average duration on the program was 11.2 months. Average injection volume was 0.36 cc per injection (range 0.1 to 1). Among those patients managed by our nurse clinician, only 3 episodes of priapism were encountered (1.7%). Scarring was documented in 7 of 170 patients (4.2%) 1 week to 21 months after starting the injections. Pain was encountered in 6 of 170 patients (3.5%). A superior dose response coupled with a low incidence of priapism, pain and scarring have led us to use triple-drug therapy as our agent of choice in the pharmacological management of erectile dysfunction.

Pulsed dye laser fragmentation of ureteral calculi: a review of the first 50 cases performed at Virginia Mason Medical Center.

During the preceding 2 1/2 years 50 patients have undergone laser fragmentation of ureteral calculi at our medical center. Of these 50 patients 48 (96%) became free of stones without the need for an open operation: 44 (88%) were managed in 1 setting and 4 required adjunctive extracorporeal shock wave or ultrasonic lithotripsy, or a repeat session with the laser. Two patients (4%) eventually required an open operation: 1 required ureterolithotomy for a large impacted stone overlying the bony pelvis after a ureteroscope could not be advanced to this level and 1 had a good initial result with the laser but a persistent ureteral stricture developed and he required ureteroureterostomy 4 months later. Both open procedures were necessitated by mid ureteral stones, and the ureteral stricture was believed to be related to ureteroscopy and the impacted nature of the stone, rather than any damage by the laser probe.