A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
NCT ID: NCT00904969
Last Updated: 2018-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2005-09-30
2009-11-30
Brief Summary
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Detailed Description
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Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMS Transobturator Male Sling System
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.
AdVance Male Sling
A transobturator sling for the treatment of post-prostatectomy incontinence
Interventions
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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.
AdVance Male Sling
A transobturator sling for the treatment of post-prostatectomy incontinence
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
MALE
No
Sponsors
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American Medical Systems
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Bales, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Hospital
Timothy Boone, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Karyn Eilber, M.D.
Role: PRINCIPAL_INVESTIGATOR
Century City Doctors Hospital
Brian J. Flynn, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Health
Michael Guralnick, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Sender Herschorn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
LeRoy Jones, M.D.
Role: PRINCIPAL_INVESTIGATOR
CHRISTUS Health
Gerald Jordan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Norfolk General
Michael Kennelly, M.D.
Role: PRINCIPAL_INVESTIGATOR
CHCS - Carolinas Medical Center
Dean L. Knoll, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centennial Hospital
Edward McGuire, M.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Michigan HS
Brian Roberts, M.D.
Role: PRINCIPAL_INVESTIGATOR
Carolina Urologic Research Center
George D. Webster, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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
Countries
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Other Identifiers
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AMS051
Identifier Type: -
Identifier Source: org_study_id
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