A randomised controlled cluster trial to evaluate an electronic system for assessing pelvic floor symptomatology in women

ISRCTN	ISRCTN75596544
DOI	https://doi.org/10.1186/ISRCTN75596544
Secondary identifying numbers	N0059132289

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 13/09/2017

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Steve Radley
Scientific

STH NHS Trust
OGN & Midwifery
G18
Jessop Wing
Sheffield
S10 2SF
United Kingdom

Phone	+44 (0)114 271 2559
Email	stephen.radley@sth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Diagnostic
Scientific title	A randomised controlled cluster trial to evaluate an electronic system for assessing pelvic floor symptomatology in women
Study objectives	We aim to evaluate the impact of a new electronic pelvic floor symptoms assessment questionnaire (e-PAQ) on the diagnosis and management of pelvic floor disorders, compared with traditional clinical interviewing. We propose to evaluate this system in a randomised, controlled cluster trial in the areas of pelvic floor medicine in which it is likely to be employed; community continence clinics (physiotherapists and continence nurses) and in secondary care (urologists, gynaecologists and colorectal surgeons). The study will focus on detection rates of symptoms, the patient's perspective of the clinical episode and subsequent referral rates and prescribing patterns.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pelvic floor symptoms
Intervention	A randomised controlled cluster trial of a new electronic pelvic floor symptoms assessment questionnaire (e-PAQ), compared with traditional clinical interviewing for the diagnosis and management of pelvic floor disorders
Intervention type	Other
Primary outcome measure	Added 28/01/10: 1. Factor analysis 2. Reliability 3. Validity 4. Patient satisfaction 5. Completion times 6. System costs
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/2003
Completion date	01/10/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Target recruitment: 1500
Key inclusion criteria	Sheffield patients
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/12/2003
Date of final enrolment	01/10/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

STH NHS Trust

Sheffield
S10 2SF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Sheffield Teaching Hospitals NHS Foundation Trust (NHS R&D Support Funding)

No information available

Urogynaecology research fund

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2006		Yes	No
Results article	results	01/10/2008		Yes	No

Editorial Notes

13/09/2017: internal review