Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB)

Completed

• Conditions: Overactive Bladder; Incontinence, Nighttime Urinary; Incontinence, Daytime Urinary
• Interventions: Procedure: Intradetrusor BoNT-A

• Registration Number: NCT06569342
• Lead Sponsor: University of Aarhus

Brief Summary

A non-intervention cohort study on the use of Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB). Primary endpoint was the reduction of urinary incontinence.

Detailed Description

The investigators wanted to cunduct an analysis of children with urinary incontinence who received intradetrusor injection of BoNT-A in the period 01.01.2016 to 31.12.2020 at their centre. All patients were refractory to standard urotherapy, anticholinergics, mirabegron and combination of treatments. Patients with neurogenic bladder were excluded.

Primary endpoints were the effect on the frequency of urinary incontinence episodes. Secondary endpoints included urodynamic parameters and uroflow characteristics in relation to side effects and response to treatment.

Study Timeline

• Study Start: 2022-01-15
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• OAB
• Intradetrusor BoNT-A

Exclusion Criteria

• Neurogenic OAB

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main group	Intradetrusor BoNT-A	Children with OAB, who underwent intradetrusor BoNT-A-injections

Primary Outcome Measures

Name	Time	Method
Incontinence episodes	1 month after treatment until request for additional treatment (up to 12 months)	Change of incontinence episodes

Secondary Outcome Measures

Name	Time	Method
Response	1 month after treatment until request for additional treatment (up to 12 months)	Identification of predictors of response
Side effects	1 month after treatment	Identification of predictors of side effects

Trial Locations

Locations (1)

Aarhus University Hospiral; 🇩🇰 Aarhus, Region Midt, Denmark