Evaluation of services for urinary dysfunction
| ISRCTN | ISRCTN94747416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94747416 |
| Secondary identifying numbers | G9410491 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 12/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr C McGrother
Scientific
Scientific
Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 2TP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study hypothesis | The objective of the phase I trial is to compare a new Continence Nurse Practitioner (CNP) led service with existing service provision for individuals with incontinence and lower urinary tract symptoms in terms of symptom severity, associated factors, impact and economic implications. Treatment in the nursing service lasts eight weeks. The new nursing service delivers a package of evidence based interventions for the provision of continence care which are protocol driven. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Urinary dysfunction |
| Intervention | 1. Existing service provision: general practitioners and primary health care team 2. Nurse led service provision: new service instituting evidence based assessment and interventions provided by specially trained nurses |
| Intervention type | Other |
| Primary outcome measure | An independent interview is carried out 13 weeks and 26 weeks after randomisation in both arms of the trial . This measures symptom severity, associated factors, impact (social and psychological) and economic aspects of the condition. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/1996 |
| Overall study end date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6000 |
| Participant inclusion criteria | Urinary dysfunction measured on a postal questionnaire (incontinence, nocturia, frequent voiding, urinary urgency) |
| Participant exclusion criteria | 1. Pregnancy 2. Malignancy 3. Fistula 4. Those already in receipt of treatment |
| Recruitment start date | 01/06/1996 |
| Recruitment end date | 31/03/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 2TP
United Kingdom
LE1 2TP
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/2002 | Yes | No |
