Plain English Summary
Background and study aims
Multiple sclerosis (MS) is a neurological condition that affects the nerves in the brain and spinal cord. These nerves are usually protected by a layer of protein called myelin. In MS, the body’s immune system mistakes myelin for a foreign body and attacks it. The myelin becomes damaged and can be partially or completely lost. This results in scars, known as lesions or plaques, and can disrupt the electrical signals from the brain travelling along the nerve fibres to the rest of the body. The nerve fibres themselves can also become damaged over time. The symptoms of MS are wide ranging and vary considerably in severity. They include semi or complete blindness, fatigue, difficulties in balance and co-ordination and spasticity. Bladder and bowel symptoms are common among both men and women with MS. Urinary and faecal incontinence can occur as individual symptoms or in combination with each other but are usually evaluated and treated independently. Pelvic floor muscle training (PFMT) is known to improve these symptoms in people without MS but less is known about its effects on MS patients. The aim of this study is to assess the feasibility of investigating PFMT to improve urinary and faecal incontinence in MS patients.
Who can participate?
Patients aged 18 or over with MS and urinary and/or faecal incontinence
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given supervised PFMT for 12 weeks led by a physiotherapist. Those in group 2 undergo the same programme for 12 weeks but unsupervised.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Southmead Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2015 to April 2017
Who is funding the study?
Multiple Sclerosis Society (UK)
Who is the main contact?
Dr Nikki Cotterill
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18358
Study information
Scientific title
Optimising pelvic floor muscle training to improve quality of life outcomes for individuals with progressive multiple sclerosis and incontinence: a feasibility study
Acronym
OPTIMISE
Study hypothesis
The aim of this study is to explore the feasibility of addressing the limitations in existing studies investigating pelvic floor muscle training (PFMT) to improve urinary and faecal incontinence in both men and women with primary and secondary progressive multiple sclerosis (MS) in order to develop a definitive trial. The main areas to be addressed are: eligibility, recruitment and retention rates, practicalities in delivery and experience of the intervention for participants, and data regarding the proposed outcome measures.
Ethics approval
First MREC approval date 18/02/2015, ref: 15/SW/0009
Study design
Randomised; Interventional; Design type: Prevention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders
Intervention
1. Self-led arm: Identical programme of pelvic floor muscle training to that in the supervised arm but this group will be self-led
2. Supervised arm: Supervised pelvic floor muscle training group exercise programme conducted weekly for twelve weeks, led by a physiotherapist
Follow Up Length: 12 month(s); Study Entry : Single Randomisation only
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Feasibility of the trial; Timepoint(s): Completion of the study.
Secondary outcome measures
N/A
Overall trial start date
10/03/2015
Overall trial end date
11/04/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years or older, NHS patients
2. Primary or secondary progressive MS diagnosis
3. UI, FI or both for at least three months
4. Participants who complete ICIQUI Short Form and report some incontinence (“About once a week or less often” to “All the time” to item 3 ICIQ-UI Short Form), and/or,
5. Participants who complete ICIQ-B and report some incontinence (“Most of the time” to “Never” to items 9, 10 or 11 ICIQ-B 04/08)
6. Cognitive capacity to complete assessments and treatment protocol (Mini Mental State Examination >8)
7. Stable disease over previous 3 months
8. Ability to contract pelvic floor muscles (perineometer response >0)
9. Participants taking LUTS medications can participate if they have been taking the medication at a stable dose for at least three months prior to study enrolment
10. Participants taking Loperamide or bowel relaxation medications can participate if they have been taking the medication at a stable dose for at least three months prior to study enrolment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 90; UK Sample Size: 90
Participant exclusion criteria
1. MS relapse including escalation of symptoms or requiring hospitalization, during the three months prior to the study
2. Introduction of new MS therapies or medications during the three months prior to the study
3. Symptomatic urinary tract infection
4. Indwelling urinary catheter if only reporting urinary incontinence (can be included with catheter if presenting with faecal incontinence for the trial)
5. Pregnancy
6. Vaginal delivery or caesarian section in previous twelve months
7. Pelvic organ prolapse that is visible beyond the intra-oitus on relaxation or cough.
8. Incontinence surgery if undertaken for presenting symptoms (if presenting with faecal incontinence for the trial and incontinence surgery has been undertaken for urinary cause they can be included, and vice versa)
9. Red flag bowel symptoms such as bleeding or recent unexplained change in bowel habit.
Recruitment start date
10/03/2015
Recruitment end date
11/04/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Urological Institute
Southmead Hospital,
Southmead Road,
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Funders
Funder type
Government
Funder name
Multiple Sclerosis Society
Alternative name(s)
MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list