Transcorporal Versus Standard Artificial Urinary Sphincter Placement

NCT ID: NCT02591381

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

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

Conditions

Urinary Stress Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STANDARD AUS Placement

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.

Group Type: EXPERIMENTAL

Artificial Urinary Sphincter Placement

Intervention Type: 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.

TRANSCORPORAL AUS 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.

Group Type: EXPERIMENTAL

Artificial Urinary Sphincter Placement

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: collaborator

Central Ohio Urology Group

OTHER

Sponsor Role: collaborator

Loyola University Chicago

OTHER

Sponsor Role: collaborator

Lahey Clinic

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Breyer, MD

Chief of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

benjamin n breyer, MD, MAS, FAC

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9224318 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12478144 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11956443 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18752838 (View on PubMed)

Other Identifiers

K12DK083021

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K12DK083021-AUS

Identifier Type: -

Identifier Source: org_study_id