A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
|ClinicalTrials.gov Identifier: NCT00998790|
Recruitment Status : Unknown
Verified March 2011 by American Medical Systems.
Recruitment status was: Active, not recruiting
First Posted : October 20, 2009
Last Update Posted : April 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Device: American Medical Systems (AMS) AdVance™ Male Sling System||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
Device: American Medical Systems (AMS) AdVance™ Male Sling System
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998790
|Universitaire Ziekenhuisen Leuven|
|Clinique Jules Verne|
|Nantes, Cedex 3, France, 44314|
|Hopital Edouard Herriot|
|Lyon Cedex 03, France, 69435|
|Principal Investigator:||Armin Becker, MD||Oberarzt der Urologischen Klinik Grosshadern|
|Principal Investigator:||Dirk de Ridder, Professor||UZ Gasthuisberg|
|Principal Investigator:||Pedro Arano, MD||Fundacion Puigvert|
|Principal Investigator:||Francois Haab, Professor||Institution Tenon Hospital|
|Principal Investigator:||Olivier Haillot, Professor||Hopital Bretonneau|
|Principal Investigator:||Philippe Chauveau, MD||Clinique Jules Verne|
|Principal Investigator:||Hakim Fassi-Fehri, MD||Hopital Edouard Herriot|