Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence, Stress Mixed Incontinence Vaginal Vault Prolapse |
Device: Vaginal Sling |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
- Safety and efficacy for incontinence and prolapse procedures.
- Quality of Life Improvement as determined by Questionnaire.
| Study Start Date: | March 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | 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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00223106 History of Changes |
| Other Study ID Numbers: | WHC03001 |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 17, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Covidien:
|
urge incontinence urinary incontinence vault prolapse stess incontinence mixed incontinence |
urine leakage enterocele rectocele cystocele |
Additional relevant MeSH terms:
|
Prolapse Urinary Incontinence Urinary Incontinence, Stress Pelvic Organ Prolapse Pathological Conditions, Anatomical |
Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013