Overview

This trial is active, not recruiting.

Condition urinary incontinence, stress
Treatment american medical systems (ams) advance™ male sling system
Phase phase 4
Sponsor American Medical Systems
Start date January 2007
End date May 2012
Trial size 113 participants
Trial identifier NCT00998790, MC0602

Summary

A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. 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. This study is not designed to statistically demonstrate safety and efficacy of the device.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To obtain procedural technique data for use in physician education and training
time frame: 24 months
To collect clinical outcomes data for future publication
time frame: 24 months

Secondary Outcomes

Measure
To record adverse events at implant and follow-up time-points
time frame: 24 months
To characterize incontinence severity at specified time-points
time frame: 24 months
To evaluate patient quality of life
time frame: 24 months

Eligibility Criteria

Male participants at least 40 years old.

Inclusion Criteria: 1. The subject has agreed to be implanted with the AMS AdVance Male 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 and has less than 250 grams on the 24-hour pad weight test. 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, or radical 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 a post-void residual ≥ 100 cc. 3. The subject has detrusor-external sphincter dyssynergia. 4. The subject has a urinary tract infection (UTI). 5. The subject was treated with pelvic radiation within the last 6 months. 6. The subject currently has an inflatable penile prosthesis. 7. The subject self-catheterizes. 8. The subject has symptomatic or unstable bladder neck structure disease. 9. The subject has a history of urethral strictures that may require repetitive instrumentation. 10. 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). 11. The subject has a history of connective tissue or autoimmune conditions. 12. The subject has a compromised immune system. 13. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction. 14. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.

Additional Information

Official title A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
Principal investigator Armin Becker, MD
Description A prospective, 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 Questionaire). Intra-operative procedural data will be collected. Pad weight and incontinence severity rating (using the ICIQ survey) 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by American Medical Systems.