An observational study in Overactive Bladder, Incontinence, Daytime Urinary and Incontinence, Nighttime Urinary, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by University of Aarhus · Observational
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.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 43 is below the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children refractory to standard treatment for OAB and incontinence.
Exclusion Criteria:
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.
Incontinence episodes
Change of incontinence episodes
Time frame: 1 month after treatment until request for additional treatment (up to 12 months)
Response
Identification of predictors of response
Time frame: 1 month after treatment until request for additional treatment (up to 12 months)
Side effects
Identification of predictors of side effects
Time frame: 1 month after treatment
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Aarhus