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

NCT06796855 | Completed Phase 4

• 1 other identifier: Bagcilar Training and Research
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Onabotulinum Toxin A; Selective Bladder Denervation; RF Ablation; Overactive Bladder; Intravesical Botox

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Overactive Bladder Assessment Tool (OAB-V8) Total Score at 12 Weeks

  The Overactive Bladder Assessment Tool (OAB-V8) is an 8-item validated questionnaire used to assess the severity of overactive bladder (OAB) symptoms, including urinary urgency, frequency, nocturia, and urge urinary incontinence. Each item is rated on a 6-point Likert scale from 0 (not at all) to 5 (a very severe problem), resulting in a total score ranging from 0 to 40, with higher scores indicating greater symptom severity. The primary outcome of this study is the change from baseline in OAB-V8 total score at 12 weeks. A clinically significant response is defined as a ≥50% reduction in total OAB-V8 score compared to baseline.

  From baseline to 12 weeks post-treatment

Secondary Outcomes (4)

• Change from Baseline in International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICQ-FLUTS) Score at 12 Weeks

  From baseline to 12 weeks post-treatment

• Change from Baseline in Incontinence Quality of Life (I-QOL) Score at 12 Weeks

  From baseline to 12 weeks post-treatment

• Change from Baseline in Urgency and Urgency Urinary Incontinence (UUI) Episodes at 12 Weeks

  From baseline to 12 weeks post-treatment

• Incidence of Treatment-Related Adverse Events at 12 Weeks

  From baseline to 12 weeks post-treatment

Other Outcomes (3)

• Change from Baseline in Daily Voiding Frequency and Nocturia Episodes at 12 Weeks

  From baseline to 12 weeks post-treatment

• Change from Baseline in Post-Void Residual (PVR) Urine Volume at 12 Weeks

  From baseline to 12 weeks post-treatment

• Incidence of Culture-Proven Urinary Tract Infections (UTIs) at 12 Weeks

  From baseline to 12 weeks post-treatment

Study Arms (2)

Selective Bladder Denervation via Radiofrequency Ablation

EXPERIMENTAL

Participants in this arm will undergo selective bladder denervation using a radiofrequency ablation procedure. This minimally invasive treatment involves applying controlled radiofrequency energy at four submucosal points in the bladder trigone area under general anesthesia. The procedure aims to reduce nerve overactivity and improve symptoms of refractory overactive bladder. Follow-up assessments will evaluate symptom improvement, safety, and quality of life over a 3-month period.

Device: Selective Bladder Denervation via Radiofrequency Ablation

Intravesical Onabotulinum Toxin A Injection

ACTIVE COMPARATOR

Participants in this arm will receive intravesical injections of Onabotulinum toxin A. A total of 100 units will be injected into 10 sites on the bladder wall under local anesthesia. This intervention is an established third-line treatment for refractory overactive bladder, aimed at reducing bladder overactivity. Symptom improvement, safety, and quality of life will be assessed during follow-up visits over a 3-month period.

Drug: Intravesical Onabotulinum Toxin A Injection

Interventions

Selective Bladder Denervation via Radiofrequency Ablation DEVICE

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.

Selective Bladder Denervation via Radiofrequency Ablation

Intravesical Onabotulinum Toxin A Injection DRUG

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.

Intravesical Onabotulinum Toxin A Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological females aged 18 years or older.
• Diagnosis of refractory overactive bladder syndrome, defined as:
• Persistent symptoms despite having completed behavioral therapy and at least two different oral pharmacotherapies (e.g., anticholinergics or beta-3 adrenergic agonists) for a minimum of 3 months each; or
• Inability to tolerate oral pharmacotherapy for overactive bladder syndrome. Willingness and ability to provide written informed consent. Ability to comply with the study protocol, including attendance at scheduled follow-up visits and completion of validated symptom assessment questionnaires (e.g., Overactive Bladder Symptom Score - OAB-V8, International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms - ICIQ-FLUTS).

You may not qualify if:

• Pregnancy or intention to become pregnant within 12 months of enrollment. History of stress urinary incontinence as the predominant symptom.
• Recent interventions prior to enrollment:
• Oral medication for overactive bladder within the past 2 weeks.
• Intravesical Onabotulinum toxin A injection within the past 9 months.
• Pelvic electrical stimulation within the past 2 weeks. Active or chronic urinary tract infection or a history of urinary retention within the past 6 months.
• Active hematuria or known bleeding disorders.
• History or current diagnosis of:
• Bladder cancer or ongoing bladder cancer treatment.
• Bladder outlet obstruction, ureteral dysfunction, ureteral stricture, or vesicoureteral reflux.
• Elevated serum creatinine level (≥2 times the upper limit of normal) within the past 6 months.
• Neurological conditions affecting bladder function, including but not limited to:
• Multiple sclerosis.
• Myasthenia gravis.
• Spinal cord injury or disease. Any condition deemed by the investigator to interfere with study participation or accurate evaluation of outcomes.

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Istanbul Bagcilar Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31359508 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.

  PMID: 29603776 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.

  PMID: 30499155 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammet M Dinçer, MD

  University of Health Sciences, Istanbul Bagcilar Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study uses a parallel design, where participants are randomly assigned to one of two groups for the duration of the study. The two groups are: The Selective Bladder Denervation group, which undergoes treatment with radiofrequency ablation (RFA). The Intravesical Onabotulinum Toxin A group, which receives onabotulinum toxin A injections into the bladder wall. Each group receives its respective intervention without crossover between treatments. Randomization was performed using the "Research Randomizer" tool to ensure an unbiased allocation of participants.

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: January 2025 - January 2026
• Access Criteria: Researchers from academic institutions, non-profit organizations, or industry with a valid scientific interest in the study outcomes will be eligible to access the data. Data will be shared with researchers upon request, subject to: * Submission of a written proposal outlining the research objectives. * Review and approval by the study investigators. Interested researchers can contact the principal investigator at: Email: zekisonmez91@gmail.com Phone: +90 505 6101066

Locations

TU (1)