Condition category
Urological and Genital Diseases
Date applied
18/03/2011
Date assigned
18/03/2011
Last edited
09/04/2015
Prospective/Retrospective
Prospectively 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

Prof Dawn Dowding

ORCID ID

Contact details

University of Leeds
Leeds
LS2 9JT
United Kingdom
+44 (0)11 3343 1199
d.dowding@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9940

Study information

Scientific title

Stage 3 Pilot Study: a decision tool to improve the management of urinary incontinence in women in the community

Acronym

Study hypothesis

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

11/H1307/1

Study design

Both; Interventional; Design type: Diagnosis, Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Amelioration of symptoms of urinary incontinence; Timepoint(s): Baseline, 1 months, 4 months

Secondary outcome measures

Not provided at the time of registration

Overall trial start date

01/04/2011

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

Participant 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

Recruitment start date

01/04/2011

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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