ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00904969
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
American Medical Systems

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Incontinence, Stress Device: The AMS Male Transobturator Sling System Device: AdVance Male Sling Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AMS Transobturator Male Sling System 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



Primary Outcome Measures :
  1. Procedural Endpoint: Procedure Time From First Incision to Closing. [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Characterize procedure time from first incision to closing.

  2. Procedural Endpoint: Type of Anesthesia Used [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Describe the type of anesthesia used.

  3. Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Number of participants requiring the use of a foley catheter intra-operatively.

  4. Procedural Endpoint: Rate of Foley Catheter Use - Post-operative [ Time Frame: post-operative to discharge ]
    Number of participants requiring the use of a foley catheter who were able to void prior to discharge.

  5. Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge [ Time Frame: post discharge ]
    Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.

  6. Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Characterize procedural parameters including the use of tack sutures.

  7. Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Characterize procedural parameters, including muscle dissection across all participants.

  8. Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.

  9. Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively [ Time Frame: During Procedure, Approximately 60 Minutes ]
    Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.


Secondary Outcome Measures :
  1. Subject Satisfaction Endpoint: 1-Hour Pad Weight [ Time Frame: Baseline to 24 month ]
    Summarize subject satisfaction of 1-hour pad weight for participants.

  2. Subject Satisfaction Endpoint: 24-Hour Pad Weight [ Time Frame: Baseline to 24 month ]
    Summarize subject satisfaction with 24-hour pad weight across participants.

  3. 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 ]
    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).

  4. 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 ]
    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).

  5. Subject Satisfaction Endpoint: Pads Per Day Use [ Time Frame: Baseline to 24 Months ]
    Summarize the subject satisfaction using pads per day use collected in follow-up in participants.

  6. Subject Satisfaction Endpoint: Quality of Life I-QOL Scores [ Time Frame: Baseline to 24 Months ]
    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.

  7. Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores [ Time Frame: Baseline to 24 Months ]
    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.

  8. Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores [ Time Frame: Baseline to 24 Months ]
    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.

  9. Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status [ Time Frame: 6 Weeks post implant to 24 Months ]
    Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations

  10. Procedural and Device Complication Rates [ Time Frame: Procedure to 24 Months Post implant ]
    Percentage of participants with serious and non-serious adverse events.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00904969     History of Changes
Other Study ID Numbers: AMS051
First Posted: May 20, 2009    Key Record Dates
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data generated from this study may be used to support clinical publications, internal device documents for marketing and/or instructional manuals, etc.

Keywords provided by American Medical Systems:
Urinary Incontinence, Stress
Intrinsic sphincter deficiency
Secondary
Transurethral Resection (TUR)
Transurethral Resection of the Prostate (TURP)
Radical prostatectomy
Open prostatectomy
Post-suprapubic prostatectomy

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders