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

NCT00904969 | Completed Results

• 1 other identifier: AMS051
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 11

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.

Conditions

Urinary Incontinence, Stress

Keywords

Urinary Incontinence, Stress; Intrinsic sphincter deficiency; Secondary; Transurethral Resection (TUR); Transurethral Resection of the Prostate (TURP); Radical prostatectomy; Open prostatectomy; Post-suprapubic prostatectomy

Outcome Measures

Primary Outcomes (9)

• Procedural Endpoint: Procedure Time From First Incision to Closing.

  Characterize procedure time from first incision to closing.

  During Procedure, Approximately 60 Minutes

• Procedural Endpoint: Type of Anesthesia Used

  Describe the type of anesthesia used.

  During Procedure, Approximately 60 Minutes

• Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative

  Number of participants requiring the use of a foley catheter intra-operatively.

  During Procedure, Approximately 60 Minutes

• Procedural Endpoint: Rate of Foley Catheter Use - Post-operative

  Number of participants requiring the use of a foley catheter who were able to void prior to discharge.

  post-operative to discharge

• Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge

  Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.

  post discharge

• Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures

  Characterize procedural parameters including the use of tack sutures.

  During Procedure, Approximately 60 Minutes

• Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection

  Characterize procedural parameters, including muscle dissection across all participants.

  During Procedure, Approximately 60 Minutes

• Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning

  Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.

  During Procedure, Approximately 60 Minutes

• Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively

  Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.

  During Procedure, Approximately 60 Minutes

Secondary Outcomes (10)

• Subject Satisfaction Endpoint: 1-Hour Pad Weight

  Baseline to 24 month

• Subject Satisfaction Endpoint: 24-Hour Pad Weight

  Baseline to 24 month

• 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)

  Baseline to 24 month

• 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)

  Baseline to 24 Month

• Subject Satisfaction Endpoint: Pads Per Day Use

  Baseline to 24 Months

Study Arms (1)

AMS Transobturator Male Sling System

EXPERIMENTAL

Device: The AMS Male Transobturator Sling System; Device: AdVance Male Sling

Interventions

The AMS Male Transobturator Sling System DEVICE

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.

AMS Transobturator Male Sling System

AdVance Male Sling DEVICE

A transobturator sling for the treatment of post-prostatectomy incontinence

Also known as: Male TO, transobturator sling, suburethral sling, retrourethral sling

AMS Transobturator Male Sling System

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Medical Systems: lead

Study Sites (11)

Century City Docotrs Hospital

Los Angeles, California, 90067, United States

Location

University of Colorado Health

Denver, Colorado, 80262, United States

Location

The University of Michigan HS

Ann Arbor, Michigan, 48109, United States

Location

CHCS - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Centennial Hospital

Nashville, Tennessee, 37203, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Christus Santa Rosa Hospital

San Antonio, Texas, 78229, United States

Location

Norfolk General

Norfolk, Virginia, 23502, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Neoplasm Metastasis

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Results Point of Contact

• Title: Laura Olson, Clinical Project Manager
• Organization: American Medical System

laura.olson2@bsci.com

952-930-6000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: September 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 30, 2018
• Results First Posted: January 30, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (10)