Menu
About the trial
Objective
The primary objective of the BladdEr Trigone TreatmEnt with Radiofrequency Denervation: Control OverActive Bladder (BETTER: Control OAB) pivotal study is to collect data on the safety and effectiveness of a new investigational treatment device to reduce urgency urinary incontinence (UUI) episodes.
Design
- Prospective, randomized, active-control, multicenter, single-blind, longitudinal study design
- All subjects will be randomly assigned to one of two active intervention arms:
- The experimental group: receives new investigational treatment
- The control group: receives existing treatment Botox® (intradetrusor onabotulinumtoxinA)
- All randomized subjects will be followed up with at 2 weeks; 1, 3, 6, 9, and 12 months; and every 6 months thereafter
- At the 6-month follow-up visit, all subjects will be evaluated to determine if they show a 50% regression to baseline in average number of UUI episodes
Eligibility
Convenience sampling will be used to enroll subjects as they present and are found to be eligible.
Review the complete list of inclusion and exclusion criteria.
About the new investigational treatment
This new investigational treatment for OAB directs radiofrequency (RF) energy into the detrusor and adventitia of the trigone to denervate the afferent nerves while maintaining healthy mucosa.
The treatment uses a cystoscopically guided device to deliver the therapy. The accompanying generator ensures the right amount of energy is delivered to maximize effectiveness without causing damage to surrounding viable tissue, such as the bladder mucosa.
Therapy delivered via a cystoscope
Outpatient procedure
Takes about 20 minutes
Treatment comparison
New investigational treatment:
Uses a cystoscope to direct RF energy into the detrusor and adventitia of the trigone to stop the nerves in the bladder from sending false urgency signals to the brainExisting treatment:
Uses a cystoscope to inject Botox into specific areas of the patient’s bladder muscles to help block the nerves to prevent the bladder muscles from involuntary contractions that cause OAB
Contact the sponsor
If you have questions about the BETTER: Control OAB Clinical Trial, including how to enroll a patient or how to become an investigator, please contact us:
By clicking “Submit” I agree to the Hologic Privacy Policy and Terms & Conditions, and I agree to receive correspondence from Hologic.
Reference: 1. Hologic, Inc. Data on file; OAB Assessment Quantitative Report, conducted July 2021. Survey of 316 women (203 who suffered from OAB; 113 who suffered from mixed incontinence). ro.2018.09.043.
