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OVERT

Botulinum toxin-A versus extended release tolterodine in the management of idiopathic overactive bladder in children: A randomised controlled trial

OVERT

Botulinum toxin-A versus extended release tolterodine in the management of idiopathic overactive bladder in children: A randomised controlled trial
Funding RfPB
Portfolio Paediatric, foetal and maternal health
Interventions CTIMP
Randomised yes
Status Completed
Start Date 20-Aug-2015

Idiopathic Overactive Bladder (IOAB) is the most common cause of urinary incontinence in children. It leads to symptoms of urgency, daytime wetting, frequency and bed-wetting. Unresolved IOAB affects a child socially, emotionally and behaviourally and if untreated, symptoms can persist into adulthood.

The OVERT study was a pilot study that aimed to provide information to inform the design and conduct of a definitive trial comparing onabotulinum toxin A with extended-release tolterodine for the management of idiopathic overactive bladder in children. Specific objectives were to assess rates of eligibility, recruitment, acceptability of randomisation, loss to follow-up, acceptability of urodynamic assessment and obtain primary outcome data for sample size estimation.

OVERT was a single-centre, parallel, two-arm, open-label pilot randomised controlled trial. Eligible patients (aged 7-16 years still symptomatic after 6 months’ anticholinergic medication and bladder training) were recruited at Royal Manchester Children’s Hospital and randomised (1:1) using a web-based system. Patients were followed up for up to 6 months with repeated measurements of bladder function, symptom assessment questionnaires and quality of life questionnaires

Publications

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