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

NCT06569342 | Completed

• 1 other identifier: OAB-BOTOX
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Incontinence, Daytime Urinary; Incontinence, Nighttime Urinary

Outcome Measures

Primary Outcomes (1)

• Incontinence episodes

  Change of incontinence episodes

  1 month after treatment until request for additional treatment (up to 12 months)

Secondary Outcomes (2)

• Response

  1 month after treatment until request for additional treatment (up to 12 months)

• Side effects

  1 month after treatment

Study Arms (1)

Main group

Children with OAB, who underwent intradetrusor BoNT-A-injections

Procedure: Intradetrusor BoNT-A

Interventions

Intradetrusor BoNT-A PROCEDURE

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.

Main group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children refractory to standard treatment for OAB and incontinence.

You may qualify if:

• OAB
• Intradetrusor BoNT-A

You may not qualify if:

• Neurogenic OAB

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospiral

Aarhus, Region Midt, 8200, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Diurnal Enuresis; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Urination Disorders; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 26, 2024
• Study Start: January 15, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)