Status:
COMPLETED
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
Lead Sponsor:
Medtronic - MITG
Conditions:
Urinary Incontinence, Stress
Mixed Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolaps...
Detailed Description
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. T...
Eligibility Criteria
Inclusion
- Subject must be female and \>18 years of age.
- Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.
Exclusion
- Any subject with clotting defects, bleeding disorders or receiving anticoagulant treatments AND is determined to be at risk for minimally invasive surgery as determined by the investigator
- Subjects who currently have an untreated urinary tract infection
- Subject is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent.
- Subject is pregnant or desires future pregnancies.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT00223106
Start Date
March 1 2004
End Date
September 1 2007
Last Update
July 27 2015
Active Locations (1)
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1
US Surgical
Norwalk, Connecticut, United States, 06856