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