Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy.

INTRODUCTION AND OBJECTIVE: Patient perception of overactive bladder (OAB) treatment outcomes can be a useful indicator of benefit and may help drive persistence on treatment, which is known to be poor in OAB. It remains unclear whether OAB patients dissatisfied with one antimuscarinic can achieve satisfaction with another and supporting data are limited. This study investigated patient-reported outcomes and clinical parameters during darifenacin treatment in OAB patients who expressed dissatisfaction with prior extended-release (ER) oxybutynin or tolterodine therapy (administered for >or= 1 week within the past year). METHODS: This open-label study was conducted in darifenacin-naïve OAB patients. Patients received 7.5 mg darifenacin once daily with the possibility of up-titrating to 15 mg after 2 weeks, for up to 12 weeks. Efficacy parameters included the Patient's Perception of Bladder Condition (PPBC), patient satisfaction with treatment, micturition frequency and number of urgency and urge urinary incontinence (UUI) episodes. Adverse events (AEs) were also recorded. RESULTS: In total, 497 patients were treated (84.1% women). Darifenacin treatment resulted in statistically significant improvements in PPBC scores, micturition frequency, urgency and UUI episodes from baseline at 12 weeks. The improvements were similar for patients previously treated with oxybutynin ER or tolterodine ER. More than 85% of patients expressed satisfaction with darifenacin. As noted in other studies, the most common AEs were dry mouth and constipation, but these infrequently resulted in treatment discontinuation, which was low overall. CONCLUSIONS: In this study, PPBC score and OAB symptoms were significantly improved, and satisfaction was high during treatment with darifenacin (7.5/15 mg) in patients who were dissatisfied with the previous antimuscarinic treatment.

Female stress urinary incontinence: review of the current literature.

Urinary incontinence is a prevalent problem that affects women of all ages. We reviewed the pathophysiology, evaluation, and treatment of stress urinary incontinence. We performed a comprehensive review of the literature using MEDLINE and resources cited in those peer-reviewed manuscripts. The results are presented. Stress urinary incontinence is defined as leakage of urine that occurs with a sudden increase in intra-abdominal pressure, such as that seen with physical activity, without concomitant rise in detrusor (bladder-generated) pressure. It is a prevalent and costly problem that affects women worldwide. Proper and thorough evaluation is imperative in order to provide patients with appropriate treatment options and accurate counseling regarding the risks, benefits, and alternatives to the available therapies. Numerous new techniques have been developed in the treatment of stress incontinence, and the approaches continue to evolve. With the increasing number of patients seeking treatment for stress incontinence, it is essential to stay current with the latest concepts in the mechanism of stress incontinence and the techniques available for its treatment. An overview of the latest literature and principles is presented.

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.

Vaginal repair of large cystoceles.

Repair of cystoceles requires a complete understanding of the pelvic anatomy. While smaller defects are relatively straightforward, greater degrees of prolapse can be among the most challenging surgeries in pelvic floor reconstruction. This article reviews current transvaginal techniques used for repair of large cystoceles.

A new technique for cystocele repair and transvaginal sling: the cadaveric prolapse repair and sling (CAPS).

A new technique using cadaveric fascia lata for the simultaneous repair of a cystocele and placement of a pubovaginal sling by means of a transvaginal approach is described, and our early results are reported. We refer to this as the cadaveric prolapse repair with sling (CaPS). Fifty patients, ages 37 to 90 years, underwent a new technique for simultaneous cystocele repair and transvaginal pubovaginal sling using a single piece of cadaveric fascia. Maximum follow-up was 6 months (range 1 to 6). A 6 x 8 cm segment of cadaveric fascia lata is placed transvaginally to repair the defect through which the bladder herniates into the vagina and to provide sling support at the bladder neck/proximal urethra. The sling is anchored to the pubic bone with transvaginal bone anchors. The remainder of the fascia is then secured to the medial edge of the levator muscles/pubocervical fascia bilaterally and at the vaginal cuff or cervix with absorbable sutures to reduce the cystocele. Patients are being evaluated with preoperative and postoperative stress, emptying, anatomy, protection, instability (SEAPI) scores as well as with grading of the prolapse based on a 3-grade anatomic classification system. Presenting symptoms have included stress urinary incontinence (SUI) in 13 (26%), urge incontinence in 4 (8%), mixed incontinence in 6 (12%), and pelvic prolapse in 20 (40%). These symptoms are not mutually exclusive; some patients presented with a combination of symptoms. The mean SEAPI scores were 5.51 preoperatively and 0.63 postoperatively, representing a significant improvement (P <0.001). Of the 40 patients whose prolapse was quantified, 1 patient (2.5%) had a minimal cystocele, 16 (40.0%) had moderate cystoceles, and 23 (57.5%) had large cystoceles. After the CaPS, 36 (72%) were completely dry, 3 (6%) had persistent SUI, 1 (2%) had de novo urinary incontinence (UI), 3 (6%) had persistent UI, and 1 (2%) had mixed incontinence. No patient had permanent urinary retention. Transvaginal placement of cadaveric fascia for concomitant sling and cystocele repair provides material of excellent strength for the repair without relying on the inherently weak tissues in the patient with pelvic prolapse. Thus far, the early results with CaPS are extremely encouraging. Long-term follow-up is underway to evaluate the efficacy of this procedure.

Pelvic prolapse.

PURPOSE: Pelvic prolapse is a common problem affecting women of all ages. We reviewed the pathophysiology, presentation, evaluation and treatment of pelvic prolapse. MATERIALS AND METHODS: We comprehensively reviewed the literature using MEDLINE, resources cited in those peer reviewed articles and abstracts from recent international meetings. RESULTS: Pelvic prolapse involves the herniation of various portions of the vaginal wall. Symptoms vary according to the area of the vagina affected. Proper evaluation is imperative for providing proper treatment. Various surgical approaches to repair have been developed and techniques continue to evolve. CONCLUSIONS: With the increasing involvement of urologists in the treatment of pelvic prolapse it is essential for us to become familiar with the anatomy, and the evaluation and management options available. We provide an overview of the care of patients with pelvic prolapse.

Undiagnosed urethral carcinoma: an unusual cause of female urinary retention.

Female urinary retention is extremely rare. Two cases of female urethral carcinoma that presented as urinary retention are reviewed and discussed.

Erosion of woven polyester pubovaginal sling.

PURPOSE: Various materials have been used for pubovaginal slings to correct female stress urinary incontinence. Use of synthetic materials provides a theoretical advantage in that no graft harvesting is necessary. Major risks of synthetic material use are erosion and infection of the sling. We report on erosion of woven polyester slings treated with pressure injected bovine collagen (ProteGen) which required removal. MATERIALS AND METHODS: Office records of patients who had ProteGen slings removed at 5 centers during the last 24 months were retrospectively reviewed. Presenting symptoms, interval between sling placement and removal, subsequent procedures and continence status following sling removal were evaluated. RESULTS: A total of 34 women required removal of the polyester sling secondary to erosion, infection or pain. The most common presenting complaints were delayed vaginal discharge in 21 patients (62%), vaginal pain or pressure in 21 (62%), suprapubic pain in 11 (32%) and recurrent urinary tract infection in 5 (15%) at a mean of 7.95 months (range 1 to 22) after sling placement. Of the patients 17 (50%) had vaginal erosion only, 7 (20%) isolated urethral erosion and 6 (17%) urethrovaginal fistulas. In 4 patients no erosion was obvious but slings were removed secondary to vaginal pain. Before sling removal 16 patients (47%) were totally dry, 13 (38%) had some degree of urinary incontinence and 3 (8%) had retention. Following sling removal 7 patients (20%) remained dry, 25 (74%) had mild to severe stress urinary incontinence with or without urgency and urge incontinence, and 2 (6%) are pending followup. CONCLUSIONS: Woven polyester slings treated with pressure injected bovine collagen are prone to erosion. Although the ProteGen sling was recalled in January 1999, patients who have had the sling placed must be followed closely.

Stress urinary incontinence.

New techniques for the treatment of female stress urinary incontinence are constantly being developed. In assessing treatment modalities, one must consider many variables including patient satisfaction and quality of life, cure or improvement rate, patient selection, and long-term durability of results. In 1998, many papers comparing and examining the outcomes of various new and old techniques were published.

Retroperitoneal laparoscopic nephrectomy in children.

PURPOSE: We report our experience with retroperitoneal laparoscopic nephrectomy and nephroureterectomy in children, and describe our surgical technique. MATERIALS AND METHODS: Five and 15 children 9 months to 17 years old underwent nephrectomy with cystoscopy plus intravesical ureteral stump fulguration for ureteral ablation and nephrectomy only, respectively. Surgical indications were unilateral multicystic dysplastic kidney in 8 cases (parental preference for surgery), a refluxing, chronic pyelonephritic kidney in 5, renal vascular hypertension in 2, and hydronephrosis and chronic pyelonephritis in 5, including 3 in whom a nephrostomy tube was placed percutaneously before laparoscopic nephrectomy. Access was obtained by a 10 mm. incision made posterior to the anterosuperior iliac spine with dissection into the retroperitoneal space and trochar placement. Two and sometimes 3 additional 5 mm. ports were placed retroperitoneally. RESULTS: Average operative time was 1 hour 42 minutes. The most recent cases were performed in less than 1 hour and in 3 nephrectomy only required 30 minutes. All but 1 procedure were completed laparoscopically. One case was converted to open surgery secondary to obscured visibility due to bleeding. Blood loss in all cases was less than 30 cc (average 5 to 10). A total of 13 children were discharged home immediately postoperatively. Five children underwent concomitant procedures, including contralateral ureteroneocystotomy in 4, circumcision in 1 and cystoscopic fulguration of the ureteral stump in 5. Those who underwent ureteral reimplantation were hospitalized for 48 hours. One patient remained hospitalized for 3 days due to fever of unknown origin and 2 were admitted to the hospital for 23-hour observation. All children returned to full activity within 1 week of surgery. Analgesia consisted of 1 dose of ketorolac, bupivacaine injections at the incisional sites at the completion of the procedure, and acetaminophen postoperatively. CONCLUSIONS: As confirmed by parent questionnaire, patient satisfaction was excellent.