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Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00223106
Enrollment
467
Registered
2005-09-22
Start date
2004-03-31
Completion date
2007-09-30
Last updated
2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed Incontinence, Urinary Incontinence, Stress, Vaginal Vault Prolapse

Keywords

urge incontinence, urinary incontinence, vault prolapse, stess incontinence, mixed incontinence, urine leakage, enterocele, rectocele, cystocele

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: * 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.

Interventions

DEVICEVaginal Sling

Sponsors

Medtronic - MITG
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Safety and efficacy for incontinence and prolapse procedures.

Secondary

MeasureTime frame
Quality of Life Improvement as determined by Questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026