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:
American Medical Systems
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00904969
First received: May 18, 2009
Last updated: March 31, 2011
Last verified: March 2011
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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:
Detailed Description:
-
Device: The AMS Male Transobturator Sling System
- Male TO
- transobturator sling
- suburethral sling
- retrourethral sling
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:
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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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 Santa Rosa Healthcare |
| 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 May 23, 2013