An interventional study of Artificial Urinary Sphincter Placement in Urinary Stress Incontinence, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-04.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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:
Pre surgery work up includes:
Post-surgery follow up:
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:
658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Inclusion Criteria:
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.
Standard placement of an artificial urinary sphincter involves a small incision made in the patient's perineum or scrotum and a fluid-filled cuff is placed around the bulbar urethra (the portion of the urethra between the bladder neck and penis). Connected to the cuff with tubing, is a balloon filled with fluid that is placed behind the pubic bone or in the space between the peritoneum and abdominal muscles. A control pump is placed in the scrotum and allows the device to cycle, thus either exerting pressure to close off the urethra or releasing pressure to allow the urethra to open and the patient to void.
Procedure: Artificial Urinary Sphincter Placement
Transcorporal placement has been introduced as a way to reduce risk of erosion and involves tunneling the cuff through the erectile bodies. The same incision is made as for the standard approach, and then an incision is made in each corpus cavernosum (cylinders of tissue that allow for erection). This allows the cuff to be placed around both the urethra and through the lining of the corporal bodies, increasing the bulk of tissue behind the urethra to protect it from erosion.
Procedure: Artificial Urinary Sphincter Placement
The AUS is the gold standard for treatment of severe stress urinary incontinence, particularly in patients following surgical resection of the prostate for prostate cancer. AUSs are small devices that prevent urinary flow via compression of the urethra, thus mimicking the native urinary sphincter.
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
Time frame: Through study completion, an average of up to 1 year
Rate of post-operative urinary retention
Urinary retention defined as urinary catheter placement for more than 5 days post-op.
Time frame: Up to 2-4 weeks
Change in 24 hour pad test at 3 months post-op compared to pre-op
Time frame: 3 months post op
Erectile function as measured pre and post AUS placement via the Sexual Health Inventory for Men (SHIM)
Sexual health is an important part of an individual's overall physical and emotional well being. This questionnaire is designed to help identify if the patient may be experiencing erectile dysfunction.
Time frame: 3 month post op, 12 month post op
Incontinence impact as measured by the Incontinence Symptom Index (ISI)
This brief questionnaire is designed to assess the severity of the patient's urinary incontinence
Time frame: 3 month post op, 12 month post op
Quality of Life impact as measured by the Incontinence Impact Questionnaire--Short Form (IIQ)
Some people find that accidental urine loss may affect their activities, relationships, and feelings. The questions in this assessment refer to areas in the subjects life that may have been influenced or changed by incontinent symptoms.
Time frame: 3 month post op, 12 month post op
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco