Botulinum toxin-A versus tolterodine for idiopathic overactive bladder
Research type
Research Study
Full title
Onabotulinum toxin-A versus extended release tolterodine in the management of idiopathic overactive bladder in children: A pilot randomised controlled trial (OVERT)
IRAS ID
120608
Contact name
Anju Goyal
Contact email
Sponsor organisation
Central Manchester University Hospitals NHS Foundation Trust
Eudract number
2014-001068-36
Clinicaltrials.gov Identifier
CTSUB597, NIHR/Wellcome Trust Children's Clinical Research Facility
Research summary
Idiopathic overactive bladder (IOAB) is the commonest cause of urinary incontinence in children with a prevalence of 5-7%. IOAB results in reduced self-esteem and has a detrimental effect on academic performance.
Untreated IOAB in childhood is associated with persisting urinary symptoms in adulthood. The social and economic impact of IOAB in adults is well documented with resultant anxiety, depression and increased healthcare usage.
The initial management is bladder training. Anticholinergic medication is the next step but has only a 20% success rate in children with severe daily wetting. Botulinum toxin-A (onaBtA) is used in adults with IOAB with good results.
Published experience in children is limited to 5 observational studies of about 139 patients. We have been using BtA in the treatment of selected children with IOAB for two years with good results.
The aim is to pilot a planned randomized controlled trial to compare the effectiveness of intravesical onaBtA with extended release tolterodine, a second line anticholinergic drug in children with IOAB aged 7-16 years.
Sixty patients who are still symptomatic after initial bladder training and at least 6 months of anticholinergic medication will be recruited. Patients will be randomly allocated to two arms of treatment. The first will receive extended release tolterodine once per day. The second arm will receive a single treatment with intravesical onaBtA under general anaesthetic.
Patients will be followed up after 6 weeks with a bladder diary, quality of life questionnaires and urodynamic study. Further follow up will be at 3 and 6 months with bladder diary, quality of life questionnaires, post void residual urine assessment.
The pilot study will assess whether our data collection tools, outcome measures, patient recruitment, and study protocol for the intended RCT are feasible and acceptable.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1199
Date of REC Opinion
21 Oct 2014
REC opinion
Further Information Favourable Opinion