Status:
COMPLETED
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
40+ years
Phase:
NA
Brief 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 ...
Detailed 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 (Incontine...
Eligibility Criteria
Inclusion
- The subject has agreed to be implanted with the AMS AdVance Male 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 and has less than 250 grams on the 24-hour pad weight test.
- 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, or radical 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.
Exclusion
- The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- The subject has a post-void residual ≥ 100 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 structure 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00998790
Start Date
January 1 2007
End Date
December 1 2012
Last Update
October 22 2018
Active Locations (3)
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1
Universitaire Ziekenhuisen Leuven
Leuven, Belgium
2
Clinique Jules Verne
Nantes, Cedex 3, France, 44314
3
Hopital Edouard Herriot
Lyon, France, 69435