Purpose of this Study
We are doing this study to find out if a medical technology called the Revi System active therapy (system is being implanted and activated) is better than non-active Revi system therapy (system is being implanted but not activated) for the treatment of urinary urge incontinence (UUI).
Who Can Participate?
Eligibility
Women ages 18+ who:<ul>
<li>Has been diagnosed with UUI for at least 6 months</li>
<li>Do not have impaired kidney function</li>
<li>Have a body mass index (BMI) that is less than 50</li></ul>
For more information about the study, contact the study team at <a href= "mailto: paige.green@duke.edu">paige.green@duke.edu.</a>
<li>Has been diagnosed with UUI for at least 6 months</li>
<li>Do not have impaired kidney function</li>
<li>Have a body mass index (BMI) that is less than 50</li></ul>
For more information about the study, contact the study team at <a href= "mailto: paige.green@duke.edu">paige.green@duke.edu.</a>
Age Range
18-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will receive the active REVI System therapy for the duration of the study. We will schedule you come to our clinic for check-ups and keep in touch with you after the device is activated to keep track of your symptoms. We will track your symptoms for 24 months.
The REVI System is an implanted device. A small cut in the skin near the ankle is made so that it can be implanted along the tibial nerve. The devices works through a process called neuromodulation, which stimulates the nervous system in a way that can change the way nerves carry information to and from the brain.
When you get the study device implanted, you will also get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will have their device begin the neuromodulation process 1 month after it is implanted.</li>
<li>The other group will have their device begin the neuromodulation process 4 months after it is implanted.</li></ul>
The REVI System is an implanted device. A small cut in the skin near the ankle is made so that it can be implanted along the tibial nerve. The devices works through a process called neuromodulation, which stimulates the nervous system in a way that can change the way nerves carry information to and from the brain.
When you get the study device implanted, you will also get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will have their device begin the neuromodulation process 1 month after it is implanted.</li>
<li>The other group will have their device begin the neuromodulation process 4 months after it is implanted.</li></ul>
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A PROSPECTIVE RANDOMIZED CONTROL TRIAL TO COMPARE THE EFFICACY OF THE REVI SYSTEM THERAPY ON VERSUS OFF IN RELIEVING URINARY URGE INCONTINENCE EPISODES
Principal Investigator
Cindy
Amundsen
Protocol Number
PRO00114306
Phase
III
Enrollment Status
Open to Enrollment