Efficacy of 200 IU OnabotulinumtoxinA in Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment

Completed

• Conditions: Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
• Interventions: Procedure: Injection of onabotulinumtoxinA into the bladder wall

• Registration Number: NCT06408051
• Lead Sponsor: Hisar Intercontinental Hospital

Brief Summary

This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Additionally, we examined the impact of significant reductions in bladder wall thickness on therapeutic outcomes.

Detailed Description

The efficacy of OnabotulinumtoxinA was investigated in patients who attended urology outpatient clinics between January 2016 and June 2022 for overactive bladder unresponsive to anticholinergic therapy. Baseline symptoms and quality of life data were compared to those at month 6 after the treatment. The voiding diary (for 3 days) of each patient was reviewed to assess and record patients' symptoms. Baseline ultrasound (US)-measured post-void residual urine (PVR) and bladder wall thickness (BWT) values were recorded. Patients with a history of neurological disorders, anticholinergic-naive patients, patients diagnosed with bladder cancer, and those with bladder outlet obstruction were excluded from the study.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-01-31
• Study Completion: 2023-07-31
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• overactive bladder urge incontinence

Exclusion Criteria

• neurological and/or neurosurgical disorders, anticholinergic-naive patients, bladder cancer, bladder stone, interstitial cystitis, prostate cancer chronic prostatitis bladder outlet obstruction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
singel	Injection of onabotulinumtoxinA into the bladder wall	-

Primary Outcome Measures

Name	Time	Method
frequencies of urination, nocturia, incontinence episodes	1 years	below 8,above 8
urgency,	1 years	present or absent

Trial Locations

Locations (2)

Basri Cakiroglu; 🇹🇷 Istanbul, Turkey

Hisar Intercontinental Hospital; 🇹🇷 Istanbul, Turkey