Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
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|ClinicalTrials.gov Identifier: NCT00223106|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress Mixed Incontinence Vaginal Vault Prolapse||Device: Vaginal Sling||Not Applicable|
Urinary incontinence is the involuntary loss of urine and can affect both men and women throughout their lives. Women are more likely to develop incontinence as a result of pregnancy and childbirth. There are approximately 11 million cases of incontinence in the US contributing to several different types of incontinence including :
- Urge - 30% of the market
- Stress - 30% of the market of which 85% are women
- Combination urge and stress - 40%
Despite advances in behavioral therapy, pharmacological advances as well as development of minimally invasive surgical procedures, only one out of every twelve people affected actually seek help.
Globally, approximately 1 million women suffer uterovaginal prolapse annually and this condition can be associated with urinary incontinence. The breakdown of treatments for uterovaginal prolapse includes:
- 20% - no treatment
- 20% - non surgical management (pessary)
- 60% - receive a surgical procedure of a suture repair or mesh repair
There were greater than 600,000 surgeries performed globally to treat prolapse. These numbers are projected to increase due to rapid, easy, and less costly methods as well as new products that facilitate the easier procedures.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||467 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- Safety and efficacy for incontinence and prolapse procedures.
- Quality of Life Improvement as determined by Questionnaire.
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): NCT00223106
|United States, Connecticut|
|Norwalk, Connecticut, United States, 06856|
|Study Director:||Noreen A. Gannon||Medtronic - MITG|