Clinical trial NCT02591381: Transcorporal Versus Standard Artificial Urinary Sphincter Placement
Official title: A Randomized Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Stress Incontinence
Keywords: urinary stress incontinence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Baylor College of Medicine
name: University of Iowa
name: University of Kansas
name: Central Ohio Urology Group
name: Loyola University Chicago
name: Lahey Clinic
name: University of Washington
name: New York University
name: University of California, San Diego
name: University of Utah
First posted: 2015-10-29
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Revision or removal surgery for AUS cuff problems other than mechanical failure: these include cuff erosion, impending erosion (discretion of surgeon), persistent retention due to small cuff, urethral atrophy
timeFrame: Through study completion, an average of up to 1 year
Secondary outcomes:
measure: Rate of post-operative urinary retention
timeFrame: Up to 2-4 weeks
measure: Change in 24 hour pad test at 3 months post-op compared to pre-op
timeFrame: 3 months post op
measure: Erectile function as measured pre and post AUS placement via the Sexual Health Inventory for Men (SHIM)
timeFrame: 3 month post op, 12 month post op
measure: Incontinence impact as measured by the Incontinence Symptom Index (ISI)
timeFrame: 3 month post op, 12 month post op
measure: Quality of Life impact as measured by the Incontinence Impact Questionnaire--Short Form (IIQ)
timeFrame: 3 month post op, 12 month post op
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: benjamin n breyer, MD, MAS, FAC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haab F, Trockman BA, Zimmern PE, Leach GE. Quality of life and continence assessment of the artificial urinary sphincter in men with minimum 3.5 years of followup. J Urol. 1997 Aug;158(2):435-9.
citation: Dalkin BL, Wessells H, Cui H. A national survey of urinary and health related quality of life outcomes in men with an artificial urinary sphincter for post-radical prostatectomy incontinence. J Urol. 2003 Jan;169(1):237-9. doi: 10.1016/S0022-5347(05)64076-1.
citation: Guralnick ML, Miller E, Toh KL, Webster GD. Transcorporal artificial urinary sphincter cuff placement in cases requiring revision for erosion and urethral atrophy. J Urol. 2002 May;167(5):2075-8; discussion 2079.
citation: Aaronson DS, Elliott SP, McAninch JW. Transcorporal artificial urinary sphincter placement for incontinence in high-risk patients after treatment of prostate cancer. Urology. 2008 Oct;72(4):825-7. doi: 10.1016/j.urology.2008.06.065. Epub 2008 Aug 26.