Transcorporal Versus Standard Artificial Urinary Sphincter Placement
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/6/2018 |
| Start Date: | October 2015 |
| End Date: | October 2017 |
A Randomized Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
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.
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.
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
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
Inclusion Criteria:
- All patients undergoing an AUS procedure would potentially be candidates for the study
Exclusion Criteria: 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
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