Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

Urinary Incontinence, Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223106
• Other study ID #: WHC03001
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 23, 2015
• Start date: March 2004
• Est. completion date: September 2007

Study information

• Verified date: July 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Mixed Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence
• Urinary Incontinence, Stress
• Vaginal Vault Prolapse

Intervention

Device:
• Vaginal Sling

Locations

Country	Name	City	State
United States	US Surgical	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy for incontinence and prolapse procedures.
Secondary	Quality of Life Improvement as determined by Questionnaire.