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

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

February 1, 2024

Study Completion Date

February 1, 2024

Conditions
Overactive Bladder SyndromeRefractory Overactive Bladder
Interventions
DEVICE

Selective Bladder Denervation via Radiofrequency Ablation

Participants in this arm will undergo a single session of selective bladder denervation using radiofrequency ablation (RFA). The procedure is performed under general anesthesia using the Apro Korea AK-F200 system, which delivers radiofrequency energy at four submucosal points in the bladder trigone area. The energy is applied at 25 watts per site for 60 seconds, targeting nerve pathways involved in overactive bladder symptoms. The procedure is conducted using a 19 Fr. rigid cystoscope in lithotomy position, ensuring precise electrode placement. Patients are discharged on postoperative day 1 following urinary ultrasound and post-void residual (PVR) assessment. Follow-up visits are scheduled at 2, 4, and 12 weeks to evaluate symptom improvement and safety.

DRUG

Intravesical Onabotulinum Toxin A Injection

Participants in this arm will receive a single dose of 100 units of Onabotulinum Toxin A injected into 10 sites on the bladder wall using a 4mm injection needle and 19 Fr. rigid cystoscope. The injection is administered under local anesthesia in an outpatient setting. The Onabotulinum Toxin A is diluted in sterile saline and delivered into the detrusor muscle, aiming to reduce detrusor overactivity and urgency symptoms. Patients undergo urinary ultrasound and post-void residual volume (PVR) assessment on postoperative day 1 before discharge. No additional doses are administered, and follow-up visits are scheduled at 2, 4, and 12 weeks to evaluate symptom improvement and safety.

Trial Locations (1)

34200

University of Health Sciences, Istanbul Bagcilar Hospital, Istanbul

All Listed Sponsors
lead

Bagcilar Training and Research Hospital

OTHER_GOV