A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement

NCT02524366 | Withdrawn FDA Device

• 1 other identifier: Elliott TC vs ST AUS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We 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 our randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. We will conduct the study through our 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

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence; Artificial Urinary Sphincter

Outcome Measures

Primary Outcomes (1)

• AUS Removal/Revision

  We will record the incidence of any repeat AUS surgery for mechanical failure, cuff erosion, impending erosion (discretion of surgeon), urethral atrophy, urinary incontinence and persistent retention due to small cuff.

  2 years

Secondary Outcomes (4)

• Urinary Retention

  8 weeks

• Incontinence

  3 months

• Incontinence Quality of Life

  3 months

• Sexual Function

  3 months

Study Arms (2)

Transcorporal AUS

EXPERIMENTAL

The artificial urinary sphincter is placed through the tunica albuginea of the corpora cavernosa in order to theoretically provide a protective backing on the urethra.

Device: Artificial Urinary Sphincter

Standard AUS

ACTIVE COMPARATOR

The artificial urinary sphincter is placed in the standard fashion.

Device: Artificial Urinary Sphincter

Interventions

Artificial Urinary Sphincter DEVICE

Standard AUS; Transcorporal AUS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men undergoing an AUS procedure
• History of pelvic radiation for prostate or other cancer
• No spontaneous erections and no erections with oral erectogenic agents
• Subjects able to consent for themselves

You may not qualify if:

• prior urethroplasty
• prior urethral erosion of AUS
• history of penile prosthesis placement or explantation
• concomitant placement of penile prosthesis at the time of AUS placement

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (5)

• 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

• 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

• 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

• Simhan J, Morey AF, Zhao LC, Tausch TJ, Scott JF, Hudak SJ, Mazzarella BC. Decreasing need for artificial urinary sphincter revision surgery by precise cuff sizing in men with spongiosal atrophy. J Urol. 2014 Sep;192(3):798-803. doi: 10.1016/j.juro.2014.03.115. Epub 2014 Apr 16.

  PMID: 24746880 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Urinary Sphincter, Artificial

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• Sean Elliott, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

US (1)