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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Injection of onabotulinumtoxinA into the bladder wall | BTX 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.