A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence (AMS051)

This study has been completed.
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00904969
First received: May 18, 2009
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence, Stress
Device: The AMS Male Transobturator Sling System
Device: AdVance Male Sling
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Improvement in patient continence status [ Time Frame: Within the first two years after surgery ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: September 2005
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: The AMS Male Transobturator Sling System
    The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
    Device: AdVance Male Sling
    A transobturator sling for the treatment of post-prostatectomy incontinence
    Other Names:
    • Male TO
    • transobturator sling
    • suburethral sling
    • retrourethral sling
Detailed Description:

A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.

Pad weight and incontinence severity rating (using the ICIQ survey) will be used to characterize continence status.

Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has agreed to be implanted with the AMS Male Transobturator Sling System.
  2. The subject is willing and able to give valid informed consent.
  3. The subject is > 40 years of age.
  4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management.
  5. 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.
  6. Internal sphincter contractility confirmed by endoscopic view.
  7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy
  8. Pre-existing urological conditions, other than incontinence have been treated and are under control.
  9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
  10. The subject is a good surgical candidate.

Exclusion Criteria:

  1. The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
  2. The subject has an atonic bladder.
  3. The subject has a post-void residual > 75 cc.
  4. The subject has detrusor-external sphincter dyssynergia.
  5. The subject has a urinary tract infection (UTI).
  6. The subject was treated with pelvic radiation within the last 6 months.
  7. The subject currently has an inflatable penile prosthesis.
  8. The subject self-catheterizes.
  9. The subject has symptomatic or unstable bladder neck stricture disease.
  10. The subject has a history of urethral strictures that may require repetitive instrumentation.
  11. 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).
  12. The subject has a history of connective tissue or autoimmune conditions.
  13. The subject has a compromised immune system.
  14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
  15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904969

Locations
United States, California
Century City Docotrs Hospital
Los Angeles, California, United States, 90067
United States, Colorado
University of Colorado Health
Denver, Colorado, United States, 80262
United States, Michigan
The University of Michigan HS
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
CHCS - Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Centennial Hospital
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Christus Santa Rosa Hospital
San Antonio, Texas, United States, 78229
United States, Virginia
Norfolk General
Norfolk, Virginia, United States, 23502
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Gregory Bales, M.D. University of Chicago Hospital
Principal Investigator: Timothy Boone, M.D. Baylor College of Medicine
Principal Investigator: Karyn Eilber, M.D. Century City Doctors Hospital
Principal Investigator: Brian J. Flynn, M.D. University of Colorado Health
Principal Investigator: Michael Guralnick, M.D. Medical College of Wisconsin
Principal Investigator: Sender Herschorn, M.D. Sunnybrook Health Sciences Centre
Principal Investigator: LeRoy Jones, M.D. CHRISTUS Health
Principal Investigator: Gerald Jordan, M.D. Norfolk General
Principal Investigator: Michael Kennelly, M.D. CHCS - Carolinas Medical Center
Principal Investigator: Dean L. Knoll, M.D. Centennial Hospital
Principal Investigator: Edward McGuire, M.D. The University of Michigan HS
Principal Investigator: Brian Roberts, M.D. Carolina Urologic Research Center
Principal Investigator: George D. Webster, M.D. Duke University
  More Information

No publications provided

Responsible Party: George D. Webster, MD, Duke University
ClinicalTrials.gov Identifier: NCT00904969     History of Changes
Other Study ID Numbers: AMS051
Study First Received: May 18, 2009
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by American Medical Systems:
Urinary Incontinence, Stress
Intrinsic sphincter deficiency
Secondary
TUR
TURP
Radical prostatectomy
Open prostatectomy
Post-suprapubic prostatectomy

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014