Comparing Treatments for Refractory Overactive Bladder: Bladder Denervation vs Botulinum Toxin Injections

Summary

The goal of this clinical trial is to compare the effectiveness and safety of two treatments for refractory overactive bladder in adult women. The main questions it aims to answer are: * Does selective bladder denervation using radiofrequency ablation improve overactive bladder symptoms more effectively than intravesical Onabotulinum toxin A injections? * What are the safety profiles of each treatment? Researchers will compare selective bladder denervation using radiofrequency ablation to intravesical Onabotulinum toxin A injections to determine which treatment is more effective and tolerable for patients whose symptoms persist despite behavioral and medical therapies. Participants will: * Be women aged 18 and older diagnosed with overactive bladder who did not benefit from at least two prior medical treatments for 3 months or were unable to tolerate those treatments. * Be randomly assigned to receive either radiofrequency ablation or Onabotulinum toxin A treatment. * Attend follow-up visits at weeks 2, 4, and 12 over a 3-month period, during which symptom improvement will be assessed using validated questionnaires and side effects will be monitored through imaging, blood, and urine tests.

Timeline

Start

2023-02-01

Primary completion

2024-02-01

Completion

2024-02-01

Publications

• Background Rovner ES, Versi E, Le Mai T, Dmochowski RR, De Wachter S. One-year results with selective bladder denervation in women with refractory overactive bladder. Neurourol Urodyn. 2019 Nov;38(8):2178-2184. doi: 10.1002/nau.24110. Epub 2019 Jul 29.
• Background Fugett J 2nd, Phillips L, Tobin E, Whitbrook E, Bennett H, Shrout J, Coad JE. Selective bladder denervation for overactive bladder (OAB) syndrome: From concept to healing outcomes using the ovine model. Neurourol Urodyn. 2018 Sep;37(7):2097-2105. doi: 10.1002/nau.23560. Epub 2018 Mar 31.
• Background Tu LM, De Wachter S, Robert M, Dmochowski RR, Miller LE, Everaert K. Initial clinical experience with selective bladder denervation for refractory overactive bladder. Neurourol Urodyn. 2019 Feb;38(2):644-652. doi: 10.1002/nau.23881. Epub 2018 Nov 29.

Drugs

Indications