Condition category
Nervous System Diseases
Date applied
26/01/2011
Date assigned
03/05/2011
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 below 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

http://www.gcu.ac.uk/

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

Publication citations

Additional files

Editorial Notes