Clinical Trials Directory

Trials / Completed

CompletedNCT06408051

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

Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients With Idiopathic

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Hisar Intercontinental Hospital · Academic / Other
Sex
All
Age
16 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREInjection of onabotulinumtoxinA into the bladder wallBTX was injected into the detrusor muscles at 20 sites

Timeline

Start date
2020-01-01
Primary completion
2022-01-31
Completion
2023-07-31
First posted
2024-05-09
Last updated
2024-12-27

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06408051. Inclusion in this directory is not an endorsement.