A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medtronic - MITG
- Enrollment
- 467
- Locations
- 1
- Primary Endpoint
- Safety and efficacy for incontinence and prolapse procedures.
Study Overview
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 prolapse.
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. 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.
Prolapse
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Safety and efficacy for incontinence and prolapse procedures.
Secondary Outcomes
- Quality of Life Improvement as determined by Questionnaire.