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

• 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: American Medical Systems
• Information provided by (Responsible Party): American Medical Systems

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• 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.

Contacts and Locations

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

• Responsible Party: American Medical Systems
• ClinicalTrials.gov Identifier: NCT00904969
• Other Study ID Numbers: AMS051
• First Posted: May 20, 2009
• 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; Behavioral Symptoms; Elimination Disorders; Mental Disorders