A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Completed · Not applicable

Conditions studied: Urinary Incontinence, Stress

In brief

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

Key facts

Study ID

NCT00904969

Run by

American Medical Systems

People needed

55

Starts

2005-09-01

Expected to finish

2009-11-01

Last updated by the study team

2018-01-30

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
• The subject is willing and able to give valid informed consent.
• The subject is > 40 years of age.
• The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
• The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
• Internal sphincter contractility confirmed by endoscopic view.
• The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
• Pre-existing urological conditions, other than incontinence have been treated and are under control.
• The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
• The subject is a good surgical candidate.

You may not qualify if…

• The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
• The subject has an atonic bladder.
• The subject has a post-void residual > 75 cc.
• The subject has detrusor-external sphincter dyssynergia.
• The subject has a urinary tract infection (UTI).
• The subject was treated with pelvic radiation within the last 6 months.
• The subject currently has an inflatable penile prosthesis.
• The subject self-catheterizes.
• The subject has symptomatic or unstable bladder neck stricture disease.
• The subject has a history of urethral strictures that may require repetitive instrumentation.
• The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
• The subject has a history of connective tissue or autoimmune conditions.
• The subject has a compromised immune system.
• The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
• The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Where it is running

• Century City Docotrs Hospital — Los Angeles, California, United States
• University of Colorado Health — Denver, Colorado, United States
• The University of Michigan HS — Ann Arbor, Michigan, United States
• CHCS - Carolinas Medical Center — Charlotte, North Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Centennial Hospital — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Christus Santa Rosa Hospital — San Antonio, Texas, United States
• Norfolk General — Norfolk, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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