- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00904969
A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence (AMS051)
A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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California
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Los Angeles, California, United States, 90067
- Century City Docotrs Hospital
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Health
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Michigan
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Ann Arbor, Michigan, United States, 48109
- The University of Michigan HS
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North Carolina
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Charlotte, North Carolina, United States, 28203
- CHCS - Carolinas Medical Center
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Centennial Hospital
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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San Antonio, Texas, United States, 78229
- Christus Santa Rosa Hospital
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Virginia
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Norfolk, Virginia, United States, 23502
- Norfolk General
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: AMS Transobturator Male Sling System
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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.
A transobturator sling for the treatment of post-prostatectomy incontinence
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural Endpoint: Procedure Time From First Incision to Closing.
Time Frame: During Procedure, Approximately 60 Minutes
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Characterize procedure time from first incision to closing.
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During Procedure, Approximately 60 Minutes
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Procedural Endpoint: Type of Anesthesia Used
Time Frame: During Procedure, Approximately 60 Minutes
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Describe the type of anesthesia used.
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During Procedure, Approximately 60 Minutes
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Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
Time Frame: During Procedure, Approximately 60 Minutes
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Number of participants requiring the use of a foley catheter intra-operatively.
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During Procedure, Approximately 60 Minutes
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Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
Time Frame: post-operative to discharge
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Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
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post-operative to discharge
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Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
Time Frame: post discharge
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Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
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post discharge
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Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
Time Frame: During Procedure, Approximately 60 Minutes
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Characterize procedural parameters including the use of tack sutures.
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During Procedure, Approximately 60 Minutes
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Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
Time Frame: During Procedure, Approximately 60 Minutes
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Characterize procedural parameters, including muscle dissection across all participants.
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During Procedure, Approximately 60 Minutes
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Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
Time Frame: During Procedure, Approximately 60 Minutes
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Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
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During Procedure, Approximately 60 Minutes
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Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
Time Frame: During Procedure, Approximately 60 Minutes
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Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.
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During Procedure, Approximately 60 Minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Satisfaction Endpoint: 1-Hour Pad Weight
Time Frame: Baseline to 24 month
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Summarize subject satisfaction of 1-hour pad weight for participants.
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Baseline to 24 month
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Subject Satisfaction Endpoint: 24-Hour Pad Weight
Time Frame: Baseline to 24 month
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Summarize subject satisfaction with 24-hour pad weight across participants.
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Baseline to 24 month
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Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)
Time Frame: Baseline to 24 month
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Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).
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Baseline to 24 month
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Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)
Time Frame: Baseline to 24 Month
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Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).
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Baseline to 24 Month
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Subject Satisfaction Endpoint: Pads Per Day Use
Time Frame: Baseline to 24 Months
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Summarize the subject satisfaction using pads per day use collected in follow-up in participants.
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Baseline to 24 Months
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Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
Time Frame: Baseline to 24 Months
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The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence.
A possible total score can be 0-100, with a higher score meaning less problems.
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Baseline to 24 Months
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Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
Time Frame: Baseline to 24 Months
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The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence.
A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed.
Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.
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Baseline to 24 Months
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Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
Time Frame: Baseline to 24 Months
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Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score.
Scores may range from 0 to 100.
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Baseline to 24 Months
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Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
Time Frame: 6 Weeks post implant to 24 Months
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Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations
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6 Weeks post implant to 24 Months
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Procedural and Device Complication Rates
Time Frame: Procedure to 24 Months Post implant
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Percentage of participants with serious and non-serious adverse events.
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Procedure to 24 Months Post implant
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Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMS051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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