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NCT Number: NCT06569342

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

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.

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Key information

Conditions

Overactive Bladder Behavior Behavioral Symptoms Diurnal Enuresis Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence, Daytime Urinary Incontinence, Nighttime Urinary Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nocturnal Enuresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospiral

Aarhus, Region Midt, 8200, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OAB
  • Intradetrusor BoNT-A

Exclusion criteria

  • Neurogenic OAB

Treatment and study plan

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.

Primary outcomes

  1. Incontinence episodes

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

    Change of incontinence episodes

Secondary outcomes

  1. Response

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

    Identification of predictors of response

  2. Side effects

    Time frame: 1 month after treatment

    Identification of predictors of side effects

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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