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

NCT06796855 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

  • Overactive Bladder Syndrome
  • Refractory 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.

Sponsors & Collaborators

  • Bagcilar Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Muhammet M Dinçer, MD · University of Health Sciences, Istanbul Bagcilar Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06796855 on ClinicalTrials.gov