Clinical Trial: The Effect of Melatonin on Nocturnal Enuresis
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Effect of Melatonin on Nocturnal Enuresis
Brief Summary: Aim: To investigate the effect of melatonin in bedwetting.
Detailed Summary: Design: Double blind randomized placebocontrolled trial using crossover.
Sponsor: University of Aarhus
Current Primary Outcome: number of incontinence episodes [ Time Frame: 10 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- nocturnal blood pressure [ Time Frame: 4 weeks ]
Time frame:
Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
- activity level [ Time Frame: 4 weeks ]
Time frame:
Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
- bladder capacity [ Time Frame: 4 weeks ]
Time frame:
Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
- nocturnal urine production [ Time Frame: 4 weeks ]
Time frame:
Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.
Original Secondary Outcome: Same as current
Information By: University of Aarhus
Dates:
Date Received: February 24, 2012
Date Started: January 2012
Date Completion: August 2013
Last Updated: November 1, 2012
Last Verified: November 2012
