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

NCT06569342 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2024-08-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569342 on ClinicalTrials.gov