Melatonin for nocturia in multiple sclerosis (MS)

Not Applicable

Completed

• Conditions: Topic: Renal and Urogenital, Nocturia in adults with multiple sclerosis; Nocturia; Urological and Genital Diseases

• Registration Number: ISRCTN38687869
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28347292 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30081859

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-04
• Study Completion: 2017-07-08
• Last Update Posted: 27 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male and female over 18 years old, upper age limit 80 years
2. Confirmed neurological diagnosis of multiple sclerosis.
3. At least 1 episode of nocturia (as defined by International Continence Society criteria [6]) every night.
4. Female subjects of childbearing potential; willing to use an effective method of contraception throughout the study.

Exclusion Criteria

1. Under 18 years old
2. Pregnant patients
3. Symptomatic urinary infection
4. Indwelling urinary catheter
5. Use of desmopressin or investigational medical compounds in the month preceding randomisation
6. Antimuscarinic or diuretic medication, unless used longterm prior to study (at least 3 months) and continued at same dosing regime throughout the study
7. Use of melatonin on prescription, or purchased over the counter/online
8. Use of ?sleeping tablets? on prescription, or purchased overt he counter/ online
9. Diabetes mellitus
10. Diabetes insipidus
11. Unwilling to give informed consent
12. Female subjects of childbearing potential; unwilling to use an effective method of contraception throughout the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 10/03/2017:<br>Nocturia episodes per night, measured from a frequency volume chart (FVC) at baseline and at the end of each treatment phase

Secondary Outcome Measures

Name	Time	Method
Added 10/03/2017:<br>1. Quality of life, measured with the MS Quality of Life Index (MSQLI), at baseline and at the end of each treatment phase<br>2. MS disease severity, measured with the MS-specific Expanded Disability Status Scale (EDSS), at baseline and at the end of each treatment phase<br>3. Urinary tract symptoms, measured with the International Consultation on Incontinence Questionnaires (ICIQ) at baseline and at the end of each treatment phase. ICIQ-MLUTS and ICIQ-FLUTS are gender specific tools for assessing severity and bother of all LUTS<br>4. Volumes passed when urinating, measured from the FVC at baseline and at the end of each treatment phase<br>5. Sleep quality, measured with the Pittsburgh Sleep Quality Index (PSQI) at baseline and at the end of each treatment phase