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
Secondary identifying numbers	9940

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

University of Leeds
Leeds
LS2 9JT
United Kingdom

Phone	+44 (0)11 3343 1199
Email	d.dowding@leeds.ac.uk

Study information

Study design	Both; Interventional; Design type: Diagnosis, Process of Care, Treatment
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Amelioration of symptoms of urinary incontinence; Timepoint(s): Baseline, 1 months, 4 months
Secondary outcome measures	Not provided at the time of registration
Overall study start date	01/04/2011
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 150; UK Sample Size: 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

England
United Kingdom

Study participating centre

University of Leeds

Leeds
LS2 9JT
United Kingdom

Sponsor information

University of York (UK)
University/education

Department of Health Sciences
York Trials Unit
Area 4
Sebohm Rowntree Building, Heslington
York
YO10 5DD
England
United Kingdom

"ROR"	https://ror.org/04m01e293

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme (ref: grant codes: PB-PG-1207-15081)

No information available

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

04/07/2017: No publications found in PubMed, verifying study status with principal investigator.