Stage 3 Pilot Study: a decision tool to improve the management of urinary incontinence in women in the community
| ISRCTN | ISRCTN89754756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89754756 |
| Protocol serial number | 9940 |
| Sponsor | University of York (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme (ref: grant codes: PB-PG-1207-15081) |
- Submission date
- 18/03/2011
- Registration date
- 18/03/2011
- Last edited
- 04/07/2017
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dawn Dowding
Scientific
Scientific
University of Leeds
Leeds
LS2 9JT
United Kingdom
| Phone | +44 (0)11 3343 1199 |
|---|---|
| d.dowding@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Both; Interventional; Design type: Diagnosis, Process of Care, Treatment |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Stage 3 Pilot Study: a decision tool to improve the management of urinary incontinence in women in the community |
| Study objectives | The overall aim of the project is to develop a decision tool for the management of urinary incontinence in women in the community that can be used by health care professionals based in primary and community care settings (GPs, practice and community nurses). The decision tool has been developed with input from clinicians through a series of focus groups and is being tested for validity and reliability. The aim of the current pilot study is the implementation of the decision tool in practice. |
| Ethics approval(s) | 11/H1307/1 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England, Renal and Urogenital; Subtopic: Not Assigned, Renal and Urogenital (all Subtopics); Disease: All Diseases, Urogenital |
| Intervention | We seek to recruit at least 60 health care professionals from each of the two study sites and as many patients as present with symptoms of UI during the course of the pilot study. Use of the decision tool: The decision tool has been developed to imrove the management of urinary incontinence in women in the community. Follow Up Length: 4 month(s); Study Entry : Other; Details: Patients will not be randomised. It is the health care professionals who will be randomised. |
| Intervention type | Other |
| Primary outcome measure(s) |
Amelioration of symptoms of urinary incontinence; Timepoint(s): Baseline, 1 months, 4 months |
| Key secondary outcome measure(s) |
Not provided at the time of registration |
| Completion date | 31/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Healthcare professionals: Any healthcare professional who works in a community/primary care setting whose role involves assessment and management of urinary incontinence in women in the community. Health care professionals will be working within two primary care trusts where NHS permissions will be sought for the study to proceed 2. Patients: Women who are over 18 years of age, not pregnant and have symptoms of urinary incontinence are eligible to be invited into the study.; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified |
| Key exclusion criteria | 1. Health care professionals who were involved in the intial development of the decision tool 2. Patients who are under 18 years of age 3. Patients who are pregnant 4. Patients who are unable to give informed consent |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
LS2 9JT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/07/2017: No publications found in PubMed, verifying study status with principal investigator.
