Optimising pelvic floor muscle training to improve quality of life out
Optimising pelvic floor muscle training to improve quality of life outcomes for individuals with progressive multiple sclerosis and incontinence: a feasibility study
What it found
We found no results in the registry or in papers.
This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.
What it measured
Main measures
Feasibility of the trial; Timepoint(s): Completion of the study.
Feasibility
Other measures (1)
N/A
Who could take part
Progressive MS · 18 and over
Show the full criteria
Inclusion criteria
Inclusion: 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 Exclusion: 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Mar 2015
Finished
Apr 2017