Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Contact information



Primary contact

Dr Nikki Cotterill


Contact details

Bristol Urological Institute
Southmead Hospital
Southmead Road
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a patient information sheet


Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders


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



Drug names

Primary outcome measure

Feasibility of the trial; Timepoint(s): Completion of the study.

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Bristol Urological Institute
Southmead Hospital, Southmead Road, Westbury-On-Trym
BS10 5NB
United Kingdom

Sponsor information


North Bristol NHS Trust

Sponsor details

Trust Headquarters
Beckspool Road
B16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Multiple Sclerosis Society

Alternative name(s)

MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies


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

Publication citations

Additional files

Editorial Notes

15/06/2016: Plain English summary added.