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Clinical Trials/NCT06408051
NCT06408051
Completed
Not Applicable

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

Hisar Intercontinental Hospital2 sites in 1 country60 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
Sponsor
Hisar Intercontinental Hospital
Enrollment
60
Locations
2
Primary Endpoint
frequencies of urination, nocturia, incontinence episodes
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
July 31, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Basri Cakiroglu

Principal Investigator

Hisar Intercontinental Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

frequencies of urination, nocturia, incontinence episodes

Time Frame: 1 years

below 8,above 8

urgency,

Time Frame: 1 years

present or absent

Study Sites (2)

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