Optimising pelvic floor muscle training to improve quality of life outcomes for individuals with progressive multiple sclerosis and incontinence
| ISRCTN | ISRCTN77817048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77817048 |
| Secondary identifying numbers | 18358 |
- Submission date
- 08/04/2015
- Registration date
- 08/04/2015
- Last edited
- 15/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Bristol Urological Institute
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| 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 acronym | OPTIMISE |
| Study objectives | 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(s) | First MREC approval date 18/02/2015, ref: 15/SW/0009 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Feasibility of the trial; Timepoint(s): Completion of the study. |
| Secondary outcome measures | N/A |
| Overall study start date | 10/03/2015 |
| Completion date | 11/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 10/03/2015 |
| Date of final enrolment | 11/04/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
England
United Kingdom
"ROR" |
https://ror.org/036x6gt55 |
|---|
Funders
Funder type
Government
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/06/2016: Plain English summary added.
