Transcorporal Versus Standard Artificial Urinary Sphincter Placement

NCT02591381 | Terminated

• 2 other identifiers: K12DK083021-AUSK12DK083021
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stress Incontinence

Keywords

urinary stress incontinence

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of up to 1 year

Secondary Outcomes (5)

• Rate of post-operative urinary retention

  Up to 2-4 weeks

• Change in 24 hour pad test at 3 months post-op compared to pre-op

  3 months post op

• Erectile function as measured pre and post AUS placement via the Sexual Health Inventory for Men (SHIM)

  3 month post op, 12 month post op

• Incontinence impact as measured by the Incontinence Symptom Index (ISI)

  3 month post op, 12 month post op

• Quality of Life impact as measured by the Incontinence Impact Questionnaire--Short Form (IIQ)

  3 month post op, 12 month post op

Study Arms (2)

STANDARD AUS Placement

EXPERIMENTAL

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 AUS Placement

EXPERIMENTAL

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

Interventions

Artificial Urinary Sphincter Placement PROCEDURE

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.

STANDARD AUS Placement; TRANSCORPORAL AUS Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Minnesota: collaborator
• Baylor College of Medicine: collaborator
• University of Iowa: collaborator
• University of Kansas: collaborator
• Central Ohio Urology Group: collaborator
• Loyola University Chicago: collaborator
• Lahey Clinic: collaborator
• University of Washington: collaborator
• New York University: collaborator
• University of California, San Diego: collaborator
• University of Utah: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (4)

• 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.

  PMID: 9224318 BACKGROUND

• 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.

  PMID: 12478144 BACKGROUND

• 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.

  PMID: 11956443 BACKGROUND

• 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.

  PMID: 18752838 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• benjamin n breyer, MD, MAS, FAC

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Urology

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

US (1)