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
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.
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
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:
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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.
The following sites are currently participating in the BETTER clinical trial. Please contact them directly if you would like to join the trial.
9300 E. 29th Street North, Suite 104
Wichita, KS 67226
Principal Investigator: Kevin Miller
12855 N. Forty Dr. South Tower, Suite 290
St. Louis, MO 63141
Principal Investigator: Travis Bullock
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