Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

Completed · Not applicable

Conditions studied: Urinary Incontinence, Stress, Mixed Incontinence, Vaginal Vault Prolapse

In brief

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.

Key facts

Study ID

NCT00223106

Run by

Medtronic - MITG

People needed

467

Starts

2004-03-01

Expected to finish

2007-09-01

Last updated by the study team

2015-07-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be female and >18 years of age.
• Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.

You may not qualify if…

• 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.

Where it is running

• US Surgical — Norwalk, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.