Intermittent self catheterisation in people with multiple sclerosis
| ISRCTN | ISRCTN46706125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46706125 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/01/2011
- Registration date
- 03/05/2011
- Last edited
- 15/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Doreen McClurg
Scientific
Scientific
NMAHP Research Unit
Glasgow Caledonian University
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
| Phone | +44 (0)141 331 8105 |
|---|---|
| Doreen.McClurg@gcal.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A prospective exploration of the experiences and factors affecting the continuity of use of intermittent self-catheterisation in people with multiple sclerosis |
| Study acronym | ISiMS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2011 |
| Completion date | 01/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Key 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 |
| Key exclusion criteria | 1. Unable to give informed consent 2. Unable to follow the study process |
| Date of first enrolment | 01/05/2011 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow Caledonian University
Glasgow
G4 0BA
United Kingdom
G4 0BA
United Kingdom
Sponsor information
Glasgow Caledonian University (UK)
University/education
University/education
c/o Professor Mike Smith
Britannia Building
City Campus
Cowcaddens Road
Glasgow
G4 0BA
Scotland
United Kingdom
| Phone | +44 (0)141 331 3490 |
|---|---|
| m.smith@gcal.ac.uk | |
| Website | http://www.gcu.ac.uk/ |
"ROR" |
https://ror.org/03dvm1235 |
Funders
Funder type
Charity
Multiple Sclerosis Society (UK) (ref: 932/10)
Private sector organisation / Associations and societies (private and public)
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 |
Editorial Notes
15/11/2017: No publications found, verifying study status with principal investigator.
