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

Not Applicable

Completed

• Conditions: Urinary Incontinence, Stress
• Interventions: Device: The AMS Male Transobturator Sling System; Device: AdVance Male Sling

• Registration Number: NCT00904969
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-09
• Primary Completion: 2009-05
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Study Completion: 2009-11
• Status Verified: 2017-01
• Results First Submitted: 2017-01-22
• Results First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Results First Posted: 2018-01-30
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMS Transobturator Male Sling System	AdVance Male Sling	-
AMS Transobturator Male Sling System	The AMS Male Transobturator Sling System	-

Primary Outcome Measures

Name	Time	Method
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative	post-operative to discharge	Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge	post discharge	Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning	During Procedure, Approximately 60 Minutes	Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Procedural Endpoint: Procedure Time From First Incision to Closing.	During Procedure, Approximately 60 Minutes	Characterize procedure time from first incision to closing.
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures	During Procedure, Approximately 60 Minutes	Characterize procedural parameters including the use of tack sutures.
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively	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.
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative	During Procedure, Approximately 60 Minutes	Number of participants requiring the use of a foley catheter intra-operatively.
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection	During Procedure, Approximately 60 Minutes	Characterize procedural parameters, including muscle dissection across all participants.
Procedural Endpoint: Type of Anesthesia Used	During Procedure, Approximately 60 Minutes	Describe the type of anesthesia used.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction Endpoint: 1-Hour Pad Weight	Baseline to 24 month	Summarize subject satisfaction of 1-hour pad weight for participants.
Subject Satisfaction Endpoint: 24-Hour Pad Weight	Baseline to 24 month	Summarize subject satisfaction with 24-hour pad weight across participants.
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	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).
Subject Satisfaction Endpoint: Pads Per Day Use	Baseline to 24 Months	Summarize the subject satisfaction using pads per day use collected in follow-up in participants.
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status	6 Weeks post implant to 24 Months	Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations
Procedural and Device Complication Rates	Procedure to 24 Months Post implant	Percentage of participants with serious and non-serious adverse events.
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	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).
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores	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.
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores	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.
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores	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.

Trial Locations

Locations (11)

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

The University of Michigan HS; 🇺🇸 Ann Arbor, Michigan, United States

Century City Docotrs Hospital; 🇺🇸 Los Angeles, California, United States

University of Colorado Health; 🇺🇸 Denver, Colorado, United States

Centennial Hospital; 🇺🇸 Nashville, Tennessee, United States

Christus Santa Rosa Hospital; 🇺🇸 San Antonio, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

CHCS - Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Norfolk General; 🇺🇸 Norfolk, Virginia, United States