Ethicon Pelvic Mesh PMCF Registry - Clinical Trial
What is the Purpose of this Study?
We are doing this study to keep tabs on the performance of a medical device called TVT Exact. This device is used to help control stress urinary incontinence. We want to know how well this device works long-term in Duke patients who elected to use it.
Stress Urinary Incontinence
Who Can Participate in the Study?
Female Duke patients ages 21+ who:
- Have a diagnosis of stress urinary incontinence
- Do not have severe vaginal atrophy
- Have never received pelvic irradiation therapy
- Are using or plan to use the TVT Exact device
For more information about who can join this study, please contact the study team at eliza.sorrell@duke.edu.
What is Involved?
If you choose to join this study, we will keep in touch with you for up to 10 years to find out how well the Exact TVT device is helping you.
The study device is composed of a piece of fabric (mesh) made of synthetic material that is shaped like a sling. Your doctor will surgically insert this mesh under your urethra, which is the short tube connected to the bladder that allows urine to pass to the outside. The device is designed to reduce urinary urgency for women and help them regain control.
We will ask you to fill out questionnaires at different times throughout the study.
Study Details
