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.
Who Can Participate?
Eligibility
Female Duke patients ages 21+ who:<ul>
<li>Have a diagnosis of stress urinary incontinence</li>
<li>Do not have severe vaginal atrophy</li>
<li>Have never received pelvic irradiation therapy</li>
<li>Are using or plan to use the TVT Exact device</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: eliza.sorrell@duke.edu">eliza.sorrell@duke.edu.</a>
<li>Have a diagnosis of stress urinary incontinence</li>
<li>Do not have severe vaginal atrophy</li>
<li>Have never received pelvic irradiation therapy</li>
<li>Are using or plan to use the TVT Exact device</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: eliza.sorrell@duke.edu">eliza.sorrell@duke.edu.</a>
Age Range
21-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
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.
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.
Locations
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse
Principal Investigator
Nazema
Siddiqui
Protocol Number
PRO00108952
NCT ID
NCT04829994
Enrollment Status
Open to Enrollment