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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Incontinence, Daytime Urinary; Incontinence, Nighttime Urinary
• Intervention / Treatment: Procedure: Intradetrusor BoNT-A

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Denmark
  • Region Midt
    • Aarhus, Region Midt, Denmark, 8200
      • Aarhus University Hospiral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children refractory to standard treatment for OAB and incontinence.

Description

Inclusion Criteria:

• OAB
• Intradetrusor BoNT-A

Exclusion Criteria:

• Neurogenic OAB

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Main group; Children with OAB, who underwent intradetrusor BoNT-A-injections

Procedure: Intradetrusor BoNT-A; For intravesical injections, BoNT-A (Allergan, Irvine, CA, USA) was diluted in 0.9% saline to 10 93 international units/ml. Multiple injections were distributed throughout the detrusor, using a 94 transurethral 23-gauge injection needle under rigid cystoscopic guidance (9.8 Fr paediatric 95 cystoscope) at 10 units/kg to a maximum of 300 units. All injections were performed under general 96 anaesthesia with antibiotic prophylaxis given intra-operative as single dose intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence episodes	Change of incontinence episodes	1 month after treatment until request for additional treatment (up to 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response	Identification of predictors of response	1 month after treatment until request for additional treatment (up to 12 months)
Side effects	Identification of predictors of side effects	1 month after treatment

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Enuresis; Nocturnal Enuresis; Diurnal Enuresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: OAB-BOTOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No