Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/01/2010
Prospective/Retrospective
Retrospectively 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

Mr Steve Radley

ORCID ID

Contact details

STH NHS Trust
OGN & Midwifery
G18
Jessop Wing
Sheffield
S10 2SF
United Kingdom
+44 (0)114 271 2559
stephen.radley@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059132289

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/12/2003

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Sheffield patients

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Target recruitment: 1500

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/12/2003

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

STH NHS Trust
Sheffield
S10 2SF
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Urogynaecology research fund

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16412003
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18553041

Publication citations

  1. Results

    Radley SC, Jones GL, Tanguy EA, Stevens VG, Nelson C, Mathers NJ, Computer interviewing in urogynaecology: concept, development and psychometric testing of an electronic pelvic floor assessment questionnaire in primary and secondary care., BJOG, 2006, 113, 2, 231-238, doi: 10.1111/j.1471-0528.2005.00820.x.

  2. Results

    Jones GL, Radley SC, Lumb J, Jha S, Electronic pelvic floor symptoms assessment: tests of data quality of ePAQ-PF., Int Urogynecol J Pelvic Floor Dysfunct, 2008, 19, 10, 1337-1347, doi: 10.1007/s00192-008-0655-2.

Additional files

Editorial Notes