OPTIMISE
Research type
Research Study
Full title
Optimising Pelvic floor muscle Training to Improve quality of life outcomes for individuals with progressive MultIple SclErosis and incontinence, a feasibility study: OPTIMISE
IRAS ID
166856
Contact name
Nikki Cotterill
Contact email
Sponsor organisation
*North Bristol NHS Trust
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
Bladder and bowel symptoms are common among men and women with primary and secondary
progressive Multiple Sclerosis (MS). Urinary incontinence (UI) and faecal incontinence (FI) 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 be effective in improving these symptoms in individuals without MS but less is know about the results in this population.
A recent review of the literature conducted by NICE regarding UI in neurological conditions identified four analyzable randomised controlled trials investigating PFMT. Whilst these studies represent the most robust trials in this area they remain limited in the conclusions that can be drawn due to the inclusion of women only, short follow-up periods, lack of detail regarding randomization procedures and small sample sizes, in addition to the overall focus being UI only. NICE thus concluded that trials conducted to date were of low quality and the quality of life data in particular was not analysable according to the standard methodologies used to grade clinical studies. Despite this, the evidence appeared to suggest that PFMT improved continence outcomes and is worthy of further investigation. The review, by NICE, has also served to accurately identify the specific requirements that should be addressed by future research, in order to fill the gaps in existing knowledge, which this study aims to address.
The aim of this study is to explore the feasibility of addressing the limitations in existing studies 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.REC name
South West - Frenchay Research Ethics Committee
REC reference
15/SW/0009
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion