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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

The investigators propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the United States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff, which is the portion of the device that encircles and occludes the urethra, is typically placed directly around the urethra (i.e., "standard" placement). The cuff can erode into the urethra. Transcorporal placement has been introduced as a method to reduce the risk of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never been compared to standard placement in a randomized fashion. In the randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. The investigators will conduct the study through an established, IRB-approved multi-institutional network of surgeons. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

Official Title

A Randomized Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement

Details

Procedure/ Methods:

Patients will be identified in the urology clinic upon their standard of care visit for AUS placement. The procedures that determine whether a patient is a surgical candidate are as follows:

  • Incontinence Impact Questionnaire Short Form (IIQ-7) and Urinary Incontinence Symptoms index (ISI) standardized questionnaires
  • Physical examination
  • Review of medical history that would preclude surgery
  • Cystoscopy to evaluate and rule out stricture
  • Uroflow/Post void residual to ensure adequate bladder capacity

Pre surgery work up includes:

  • Urine analysis and if indicated urine culture and treatment of urinary tract infection
  • Flow, post-void residual if possible
  • Cystoscopy to rule out bladder neck contracture or urethral stricture
  • History and physical examination
  • Treatment of men with 2 days of chlorhexidine wash to the perineum
  • Incontinence sexual function questionaires
  • Aminogllycoside and other abx prior to surgery
  • 24 hour pad weight

Post-surgery follow up:

  • Routine removal of catheter within 5 days post-op
  • Treatment of antibiotics post-operatively to be limited to 1 week
  • Activation of AUS at 4-8 weeks post-op
  • Incontinence sexual function questionnaires
  • 24 hour pad weight

Routine follow ups will be conducted at 2 weeks, 6 weeks, 3 months, 6 months post-operatively, and yearly thereafter (SOC). Patient characteristics that will be collected include:

  • etiology of the incontinence.
  • pre-operative pad usage
  • prior anti-incontinence procedures
  • adjuvant therapy for prostate cancer such as radiotherapy, or other history of pelvic radiation
  • post-operative urodynamic studies
  • cystoscopy findings

Keywords

Urinary Stress Incontinence Urinary Incontinence, Stress

Eligibility

You can join if…

Open to males ages 18 years and up

  • All patients undergoing an AUS procedure would potentially be candidates for the study

You CAN'T join if...

There are several situations in which either a TC or ST procedure would be specifically indicated, and it would be unethical to randomize these patients to the other procedure.

  • No men without erectile dysfunction
  • No use of injectable agents into the corporal body
  • No prior urethral surgery (Prior surgery defined as; urethroplasty, urethral sling,prior AUS placement or explantation, recto-urethral fistula closure)
  • No current penile prosthesis
  • No concomitant placement of penile prosthesis at the time of AUS placement
  • Males under the age of 18, as well as females, are also excluded

Location

  • University of California San Francisco accepting new patients
    San Francisco, California, 94143, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02591381
Lead Scientist
Benjamin Breyer
Study Type
Interventional
Last Updated
July 2016
I’m interested in this study!