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

NCT ID: NCT06408051

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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singel

Injection of onabotulinumtoxinA into the bladder wall

Intervention Type PROCEDURE

BTX was injected into the detrusor muscles at 20 sites

Interventions

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Injection of onabotulinumtoxinA into the bladder wall

BTX was injected into the detrusor muscles at 20 sites

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hisar Intercontinental Hospital

OTHER

Sponsor Role lead

Responsible Party

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Basri Cakiroglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Basri Cakiroglu

Istanbul, , Turkey (Türkiye)

Site Status

Hisar Intercontinental Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10.11.203/23-54

Identifier Type: -

Identifier Source: org_study_id