Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
593
Study information
Scientific title
Acronym
Study hypothesis
To test the hypothesis that the new treatment approach of an educational group has a significantly greater effect on:
1. Physical symptoms
2. Life quality in women with FUI than the individual home help method
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and genital diseases: Incontinence
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pad test, pelvic floor muscle power, Incontinence report questionnaire, Symptom severity Index and Visual Analogue Scale.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/1996
Overall trial end date
01/03/1998
Reason abandoned
Eligibility
Participant inclusion criteria
All female patients aged 18-75 years with a clinical diagnosis of stress and/or urge incontinence will be considered for inclusion.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/1996
Recruitment end date
01/03/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Physiotherapy Department
Lichfield
WS13 6QN
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive West Midlands (UK)
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. 2005 results in "South Warwickshire General Hospital NHS Trust's 'Small Project's Scheme' report"