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Completed

NCT Number: NCT06408051

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

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.

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Key information

Conditions

Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Basri Cakiroglu, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of onabotulinumtoxinA into the bladder wall

Procedure

BTX was injected into the detrusor muscles at 20 sites

Primary outcomes

  1. frequencies of urination, nocturia, incontinence episodes

    Time frame: 1 years

    below 8,above 8

  2. urgency,

    Time frame: 1 years

    present or absent

Sponsors and collaborators

Lead sponsor

Hisar Intercontinental Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 9, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.