The Nocturnal Enuresis Alarm Therapy (NEAT) Study
Phase 3
Completed
- Conditions
- octurnal enuresisNocturnal enuresisRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12609000070235
- Lead Sponsor
- ational Health and Medical Research Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Children >6 years with nocturnal enuresis for at least 3 nights per week for which enuresis alarm therapy is indicated
Exclusion Criteria
Children with organic cause for nocturnal enuresis, defects of central nervous system or significant underlying urological abnormalities or those where alarm therapy is contraindicated.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients cured at 4 months measured by a bladder diary[Daily recordings of wet/dry nights collected every 2 weeks for 4 months]
- Secondary Outcome Measures
Name Time Method Time to achieve cure measured by bladder diary[Daily recordings of wet/dry nights collected every 2 weeks for 4 months];Proportion of patients relapsed by 12 months. Relapse is defined as greater than 2 nights of wetting/fortnight after achieving cure.[12 months];Response to alarm stimulus will be measured by a bladder diary[Daily recordings of wet/dry nights, waking to void and time to achieve cure will be collected every 2 weeks for 4 months];Adverse outcomes (disturbed sleep) will be assessed daily by a bladder diary kept by the participants.[Daily recordings of any adverse outcomes collected every 2 weeks for 4 months];Overall response to treatment (cure rate) in both arms will be measured by a bladder diary[Daily recordings of wet/dry nights, waking to void, time to achieve cure and any relapse will be collected every 2 weeks for 12 months]