Melatonin for Nocturia in MS
What it found
The main measure did not show a significant benefit.
“The primary outcome measure, mean number of nocturia episodes on bladder diaries, was 1.8/night at baseline, and 1.4/night on melatonin, compared with 1.6 for placebo (Medians 1.70, 1.50, and 1.30 respectively, p = 0.85).”Read by software from the paper's abstract
| Group | n | Value |
|---|---|---|
| Baseline | 34 | 1.8/night |
| Placebo | 1.6/night |
p = 0.85
Total participants: 34
Read by software from the paper's abstract
What was tested
Treatment tested
- Melatonin
Melatonin receptor agonist
What it measured
Main measures
Reduction in nocturia episodes per night (Frequency Volume Chart/Bladder Diary)
Bladder, bowel and sexual functionAdded 10/03/2017: Nocturia episodes per night, measured from a frequency volume chart (FVC) at baseline and at the end of each treatment phase
Bladder, bowel and sexual function
Other measures (2)
1. Safety of intervention
SafetyAdded 10/03/2017: 1. Quality of life, measured with the MS Quality of Life Index (MSQLI), at baseline and at the end of each treatment phase 2. MS disease severity, measured with the MS-specific Expanded Disability Status Scale (EDSS), at baseline and at the end of each treatment phase 3. Urinary tract symptoms, measured with the International Consultation on Incontinence Questionnaires (ICIQ) at
Disability progressionBladder, bowel and sexual functionMood and sleepQuality of life (reported by participants)
Who could take part
Progressive MS · 18 to 80
Inclusion: - Over 18 years old Exclusion: - Under 18 years old
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary aim is to evaluate whether melatonin medication reduces the number of times a patient with multiple sclerosis has to get out of bed at night to pass urine.
Papers
Results
Results of a randomized, double blind, placebo controlled, crossover trial of melatonin for treatment of Nocturia in adults with multiple sclerosis (MeNiMS).BMC Neurol · 2018
The primary outcome measure, mean number of nocturia episodes on bladder diaries, was 1.8/night at baseline, and 1.4/night on melatonin, compared with 1.6 for placebo (Medians 1.70, 1.50, and 1.30 respectively, p = 0.85).
Read by software from the paper's abstract
Results
Protocol for a randomized, double blind, placebo controlled, crossover trial of Melatonin for treatment of Nocturia in adults with Multiple Sclerosis (MeNiMS).BMC Neurol · 2017
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History
Started
Dec 2012
Finished
Jul 2017
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