Watch with Alarm for Timed-voiding in Children (WATCH) Study
Phase 3
- Conditions
- Daytime urinary incontinenceRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12611000828921
- Lead Sponsor
- The Children's Hospital at Westmad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
Children aged 5 to 13 years who have DUI at least twice per week (in the past 2 weeks) for which a timed voiding program is indicated
Exclusion Criteria
Children with an organic cause for DUI including defects of central nervous system or underlying urological abnormality or where a timed voiding program is contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients cured at 3 months measured by a bladder diary[Daily recordings of wet/dry days collected every 2 weeks for 3 months]
- Secondary Outcome Measures
Name Time Method Time to achieve cure measured by a bladder diary[Daily recordings of wet/dry days collected every 2 weeks for 3 months];Change in daytime wetting (compared to baseline)[Daily recordings of wet/dry days collected every 2 weeks for 3 months];Completeness of bladder emptying (compared to baseline)[End of treatment at 3 months using uroflow measurements.];Proportion relapsed by 6 months (to assess whether treatment success is sustained)[2 monthly recordings.];Satisfaction questionnaire incorporating the child and families satisfaction with the treatment protocol including their attitude to the watch, length of treatment, relapse and their overall satisfaction of treatment received[End of treatment (at 3 months)];Quality of life[Measured at baseline and end of treatment (at 3 months). Quality of life will be assessed using a validated questionnaire.]