A randomized, controlled clinical trial of a novel intravesical pressure attenuation device for the treatment of stress urinary incontinence.

PURPOSE: In this clinical trial we evaluated the efficacy, safety and tolerability of a novel pressure attenuation device for the reduction or elimination of female stress urinary incontinence using a prospective, randomized, single-blind, multicenter design. MATERIALS AND METHODS: A total of 166 female patients with stress urinary incontinence were randomized 2:1 to treatment with an intravesical pressure attenuation device (112) or sham procedure (54). In the treatment arm the device was replaced every 90 days and in the sham arm device replacement was simulated every 90 days. The primary outcome measure was Stamey score improvement of 1 or more at 6 months. An additional outcome measure evaluated at 6 months was a composite score combining data from a provocative pad test and patient impression of symptom improvement. RESULTS: In the treatment arm 40.9% of women achieved the primary end point, compared to only 22.4% in the sham arm (p=0.046 in per protocol analysis). In an intent to treat analysis, 28.6% of women in the treatment arm reached the primary end point vs 22.2% of women in the sham arm (p=0.455). 50.8% of women in the treatment arm reached the composite end point compared to 16.3% of women in the control arm (p<0.001, intent to treat analysis). Three-day voiding diaries revealed a mean reduction in total daily leakage events after 6 months from 4.4 per day to 2.5 per day (43.2%) in the treatment group vs 5.4 per day to 4.1 per day (24.1% reduction) in the control group (p<0.001). CONCLUSIONS: Minimally invasive treatment for female stress urinary incontinence with a first-generation intravesical pressure attenuation device was safe and effective when evaluated by a composite end point. For those patients that can tolerate the device, the concept of pressure attenuation as a therapy for stress urinary incontinence is valid and feasible. Further modifications are anticipated for this device potentially resulting in improved outcomes.

Role of invasive urodynamic testing in benign prostatic hyperplasia and male lower urinary tract symptoms.

The role of urodynamics in the evaluation of lower urinary tract symptoms in men with benign prostatic hyperplasia is controversial despite the additional information regarding bladder function and outlet obstruction it provides. This controversy is primarily based on outcome studies that suggest men without proved bladder outlet obstruction may benefit from outlet reduction with medication or surgical resection. The aim of this article is to describe the role of urodynamic studies in the evaluation of benign prostatic hyperplasia, including illustration of existing urodynamic techniques, reviewing best practice guidelines and current literature, and providing recommendations for use of urodynamics in clinical practice.

Current evaluation and management of female urethral diverticula.

The identification of female urethral diverticula remains a challenging problem for many clinicians. Many of these patients are often undiagnosed or misdiagnosed due to a clinical presentation that frequently mimics other pathologic processes. There can be significant variation in the urethral diverticular anatomy in terms of size, location, and configuration. This update provides a succinct and comprehensive review of the clinical presentation, evaluation, and treatment options for female urethral diverticula.

Initial experience with rectocele repair using nonfrozen cadaveric fascia lata interposition.

OBJECTIVES: To describe a rectocele repair reinforced with solvent-dehydrated, gamma-irradiated, human fascia lata and report our early results with a technique we are confident will have a greater, more durable success rate, with a lower incidence of dyspareunia, than the classic repair. METHODS: A total of 73 patients, aged 31 to 86 years, with symptomatic (stool trapping and/or vaginal/perineal splinting or postural modifications to facilitate stool evacuation) rectoceles underwent a site-specific repair reinforced with cadaveric fascia. Perioperative questionnaires, retrospective chart review, and telephone interview by a blinded third-party reviewer and physical examination was conducted. Issues thought to be relevant to the rectocele repair were assessed. RESULTS: Of the 73 patients, 62 responded to the postoperative questionnaire and 50 underwent physical examination. The mean follow-up was 13.7 months (range 6 to 23). Of the 62 patients, 52 (93.6%) denied postoperative stool trapping requiring vaginal/perineal splinting. Of the 39 sexually active patients, 4 (10.3%) experienced de novo dyspareunia. Minor complications were seen in 15 patients (24%). One developed a symptomatic enterocele. CONCLUSIONS: Interposition of cadaveric fascia lata avoids dependence on weakened native rectovaginal support to facilitate the rectocele repair. Our technique uses fascial interposition, rather than obliteration of the defect, preventing vaginal narrowing, and should thereby decrease the incidence of dyspareunia. Patient symptom improvement and satisfaction rates were competitive with those after traditional rectocele repair. Follow-up is ongoing with the hope that the fascial reinforcement will translate into more durable results.

Cadaveric prolapse repair with sling: intermediate outcomes with 6 months to 5 years of followup.

PURPOSE: We present the prospective, intermediate-term results for cadaveric prolapse repair with sling as combined treatment of stress urinary incontinence and cystocele. MATERIALS AND METHODS: A total of 251 of 295 (85%) patients undergoing cadaveric prolapse repair with sling (CaPS) had at least 6 months of questionnaire and pelvic examination followup. All patients had objectively demonstrated stress urinary incontinence and grade 2 to 4 cystocele before surgery. Followup outcome measures included a validated subjective continence and patient satisfaction questionnaire, SEAPI (stress incontinence, emptying, anatomy, protection, inhibition) scores, pelvic examination for prolapse recurrence and complications, and quality of life scores. RESULTS: The overall patient reported subjective incontinence cured/dry rate (no incontinence episodes of any type) was 114 of 251 (45%), the cured/improved rate (50% improvement or greater) was 192 of 251 (76%) and the failed rate (less than 50% improvement) was 59 of 251 (24%). When considering stress urinary incontinence the cured/dry rate was 141 of 251 (56%), cured/improved rate was 207 of 251 (82%) and failed rate was 44 of 251 (17.5%), with 17 of the 44 (39%) cases having mixed urinary incontinence. Of the 59 failures 33 (56%) occurred after 12 months of followup. Of 153 patients 13 (8.5%) experienced de novo urge incontinence. The symptomatic cystocele recurrence rate was 18 of 251 (7%). There were statistically significant improvements in SEAPI and prolapse quality of life scores. Of 251 patients 200 (80%) were at least 50% satisfied and of 251 193 (77%) stated they would undergo the CaPS procedure again. CONCLUSIONS: With a maximum followup of 5 years in patients undergoing CaPS, we have seen excellent, durable cystocele repair results. While our subjective continence rates have decreased with an increasing number of late failures, we continue to observe significant improvement in SEAPI scores and quality of life with good patient satisfaction and low morbidity.

Osseous complications after transvaginal bone anchor fixation in female pelvic reconstructive surgery: report from single largest prospective series and literature review.

OBJECTIVES: To report, from our prospective database and review of published studies (including primary reported patient series and case reports for osseous complications after transvaginal bone anchor fixation in female pelvic reconstructive surgery), our results and those from previously reported patient series to determine the incidence of osteitis pubis and osteomyelitis. METHODS: A total of 440 patients from our database of cadaveric transvaginal sling (n = 127) and cadaveric prolapse repair with sling (n = 313) procedures had at least 3 months of examination follow-up and were included in this report. We found 15 primary reported patient series involving transvaginal bone anchor fixation in published studies, for a total of 788 patients. The combined patient population of 1228 was assessed for the incidence of osteitis pubis and osteomyelitis. RESULTS: Of our 440 patients included in this study, 2 developed osteitis pubis (0.45%), and none had osteomyelitis (0%). In the published studies we reviewed, no case of osteitis pubis and 1 case of osteomyelitis (1 of 788, 0.13%) were reported. One additional case of osteomyelitis with transvaginal bone anchor fixation was reported. The combined incidence of osteitis pubis was 2 (0.16%) of 1228, and the combined incidence of osteomyelitis was 1 (0.08%) of 1228. CONCLUSIONS: In procedures using transvaginal bone anchor fixation in female pelvic reconstructive surgery, the combined incidence, from our experience and that reported in published studies, of osteitis pubis and osteomyelitis was 2 (0.16%) and 1 (0.08%) of 1228, respectively. The infectious osseous complication rate associated with transvaginal pubic bone anchor fixation appears to be less than that previously reported for suprapubic bone anchor placement. In our experience, when using careful surgical technique and proper prophylactic precautions, infectious osseous complications have not been encountered.

Abdominal sacral colpopexy for repair of neovaginal prolapse in male-to-female transsexuals.

Penectomy, bilateral orchiectomy, and penoscrotal flap vaginoplasty are procedures that increase the psychosocial well-being and enhance body acceptance of male-to-female transsexuals. The incidence of neovaginal prolapse is not known but is believed to be relatively rare. We report 2 cases of neovaginal prolapse that were successfully treated with abdominal sacral colpopexy at our institution.

Transvaginal surgery in the octogenarian using cadaveric fascia for pelvic prolapse and stress incontinence: minimal one-year results compared to younger patients.

OBJECTIVES: To evaluate prospectively our transvaginal surgery experience in octogenarian women and compare the results with those in younger patients. As our population has aged, the treatment of incontinence and prolapse in women older than 80 years, known as octogenarians, has become a significant clinical issue. METHODS: To date, our prospective database includes 455 women who have undergone transvaginal sling surgery using nonfrozen cadaveric fascia lata with or without concurrent prolapse repair. Of these, 51 (11%) were at least 80 years old at surgery. Complete follow-up was defined as pelvic examination findings, validated questionnaire responses (incontinence and quality of life), and SEAPI (Stress, Emptying, Anatomy, Protection, and Instability) score. The outcomes analysis was focused on the 31 octogenarian women with a minimum of 1 year of complete follow-up and compared their data with the data of 234 younger women with an identical minimal follow-up time. RESULTS: The mean octogenarian age was 83 years (maximal age 93). The mean octogenarian questionnaire and examination follow-up was administered at 21.4 months and 17.5 months, respectively. Of the 31 octogenarians, 17 (55%) reported continence improvement of greater than 70%, and 28 (90%) had no symptomatic recurrent prolapse. Compared with younger patients, no statistically significant difference in outcome parameters was identified. The rates of persistent urgency and urgency in dissatisfied patients were greater in octogenarian women, but did not reach statistical significance. Statistically significant improvement in the octogenarian quality-of-life measures was demonstrated. No perioperative complications occurred. CONCLUSIONS: Transvaginal incontinence and/or prolapse surgery may be safely performed in octogenarian women, with resultant improvement in quality-of-life measures. Although outcomes after transvaginal surgery were comparable between octogenarian and younger women, persistent urgency may predict dissatisfaction in the octogenarian population.

Urethrolysis with Martius labial fat pad graft for iatrogenic bladder outlet obstruction.

This article evaluates treatment outcomes of urethrolysis with the Martius labial fat pad graft for patients with outlet obstruction after incontinence surgery. A total of 23 women were diagnosed with iatrogenic bladder outlet obstruction by urinary retention, urodynamic criteria, physical examination findings, and/or temporal relation of voiding dysfunction to anti-incontinence surgery. The urodynamic definition of female outlet obstruction was a maximum flow rate <12 mL/sec and a detrusor pressure at maximum flow >20 cm of water. Surgical treatment consisted of urethrolysis with complete circumferential urethral mobilization. A Martius labial fat pad graft was used to circumferentially wrap the urethra. No concurrent resuspension procedures were performed. Procedure efficacy was determined by retrospective review and phone interview. Mean patient age was 55 years (range, 37 to 85 years). Mean postoperative follow-up time was 15 months (maximum, 44 months). All patients related voiding dysfunction symptoms to their anti-incontinence surgery. In all, 17 of 23 (74%) patients had preoperative urinary retention requiring catheterization, and 63% of patients met urodynamic criteria for obstruction. After urethrolysis with a Martius labial fat pad graft, 20 of 23 (87%) patients had complete resolution of their obstruction; 3 patients required persistent catheterization. Postoperative stress incontinence was reported by 6 of 23 (13%) patients. Urodynamically documented detrusor instability occurred in 6 of 23 (26%) patients with de novo detrusor instability occurring in 3 of 15 (20%) patients.

Needle suspension procedures for female incontinence.

In the past, needle suspensions were considered a viable option to treat female stress urinary incontinence. There have been many modifications since the first needle suspension over 40 years ago. Despite these modifications, the long-term outcome data does not support the efficacy of needle suspension procedures, with only a 67% cure/dry rate at > 48 months. The long-term results are much more efficacious with the sling procedure (83%), as well as with retropubic suspensions (84%). Needle suspensions have historical significance, but because of the poor long-term results, they currently have a limited role in the management of stress urinary incontinence.

Continued multicenter followup of cadaveric prolapse repair with sling.

PURPOSE: Since our initial description of the technique of combining a transvaginal sling with a cystocele repair using solvent dehydrated cadaveric fascia lata and bone anchors we have continued to follow our outcomes closely to determine long-term results. We present the updated, multicenter results of the cadaveric prolapse repair with sling. MATERIALS AND METHODS: A total of 172 patients 35 to 90 years old (mean age 62.1) have undergone cadaveric prolapse repair with sling with a mean followup of 12.4 months (range 6 to 28). Of these patients 132 (76.7%) completed followup. Repair was performed for grade 2 cystoceles in 73 cases, grade 3 cystoceles in 43 and grade 4 cystoceles in 16. Followup included physical examination (degree of pelvic prolapse), SEAPI scores, complications, patient reported continence, perceived improvement and satisfaction. The latter 2 parameters were obtained using a validated questionnaire. RESULTS: Of the 132 patients 15 (11.4%) had grade 1 and 2 (1.5%) had grade 2 cystocele recurrence, which required no further treatment, and 13 (9.8%) had recurrent or de novo apical vaginal prolapse. Preoperative and postoperative SEAPI scores were 5.58 and 0.9, respectively (p <0.001). A total of 90 patients (68.2%) do not use any pads for protection. Of the 132 patients 24 (18.2%) have stress incontinence of any degree, including 14 (10.6%) with pure stress urinary incontinence, 8 (6.0%) report de novo urge incontinence, 26 (19.7%) have persistent urge incontinence, 21 (15.9%) have any degree of urgency without urge incontinence, 28 (21.2%) report resolution of preoperative urgency or urge incontinence symptoms, 7 (5.3%) have mixed incontinence and 1 had prolonged urinary retention requiring urethrolysis. There has been 1 case of osteitis pubis and no osteomyelitis. Of the patients 94 (71.2%) reported greater than or equal to 70% subjective improvement overall, including 12 who were dry preoperatively, 99 (75.0%) were greater than or equal to 70% satisfied, 105 (79.9%) would repeat the surgery and 102 (77.4%) would recommend the surgery to a friend. With regard to continence 31 (23.8%) patients were less than or equal to 50% improved. A total of 108 (81.8%) patients have no stress urinary incontinence, and patient improvement, satisfaction and complication rates have been acceptable. We have been particularly impressed by the results of the cystocele repair. Surgeons must consider that patient perceived improvement and satisfaction level are essential components of the measure of success or failure of a given therapy. CONCLUSIONS: With a maximum of 28 months of followup of the cadaveric prolapse repair with sling procedure, we continue to be satisfied with the success of the cystocele repair and the competitive stress urinary incontinence cure rate.