Contact information
Type
Scientific
Primary contact
Dr Doreen McClurg
ORCID ID
Contact details
NMAHP Research Unit
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 8105
Doreen.McClurg@gcal.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective exploration of the experiences and factors affecting the continuity of use of intermittent self-catheterisation in people with multiple sclerosis
Acronym
ISiMS
Study hypothesis
People with multiple sclerosis (MS) may be advised to undertake intermittent self-catheterisation (ISC) to help manage their bladder. However, research shows that although the use of ISC is supported both by clinicians and MS population in general, many do not find it acceptable and discontinue use after a while. Research indicates that there are gaps within current knowledge relating to the experiences of and the factors affecting ISC within this population. Therefore, in order to better understand the factors that impact ISC use and continuation, the Multiple Sclerosis Society has funded a study in which we will recruit 250 people with MS who are learning to use ISC and follow them for 12 months to investigate how patients experience ISC and the issues which impact its use.
Ethics approval
Not provided at time of registration
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Multiple sclerosis
Intervention
Data will be collected at four different points: baseline, 4, 8 and 12 months and in three ways:
1. Assessment log, recording (among other things) patient demographics, medical history, bladder symptoms, socio-economic status
2. Telephone-based questionnaires measuring quality of life including clinical data collection booklet - to be completed by the clinician
3. In addition to clinical data, semi-structured qualitative interviews will be conducted with a purposively selected sample of 12 - 20 patients at 4 and 12 months. These will enable us to have an in-depth understanding of the issues, dynamics and impact of ISC including the factors which lead to its discontinuation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Completed at 4, 8 and 12 months:
1. Bladder diary
2. Qualiveen Questionnaire
3. International Consultation on Incontinence Modular Questionnaire (ICIQ) - Female Lower Urinary Tract Symptoms (FLUTS) and Male Lower Urinary Tract Symptoms (MLUTS)
Secondary outcome measures
Completed at 4, 8 and 12 months:
1. Assessment Log
2. Clinical Data Collection Booklet
3. Semi-structured interviews
Overall trial start date
01/05/2011
Overall trial end date
01/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. People with MS
2. Aged 18 - 80 years, either sex
3. Have agreed with their clinician to be taught ISC
4. Willing to take part in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Unable to give informed consent
2. Unable to follow the study process
Recruitment start date
01/05/2011
Recruitment end date
01/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glasgow Caledonian University
Glasgow
G4 0BA
United Kingdom
Sponsor information
Organisation
Glasgow Caledonian University (UK)
Sponsor details
c/o Professor Mike Smith
Britannia Building
City Campus
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+44 (0)141 331 3490
m.smith@gcal.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Society (UK) (ref: 932/10)
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
Results - basic reporting
Publication summary