Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0282131250
Study information
Scientific title
A prospective randomised controlled trial of pelvic floor exercises plus biofeedback versus pelvic floor exercises alone in treating stress urinary incontinence
Acronym
Study hypothesis
Assess the effectiveness of biofeedback with pelvic floor exercises compared to pelvic floor exercises alone in women with stress urinary incontinence.
Ethics approval
Not provided at time of registration
Study design
Randomised prospective assessment and cross over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Urological and Genital Diseases: Urinary incontinence
Intervention
Biofeedback with pelvic floor exercises compared to pelvic floor exercises alone
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Quality of life. Medical Epidemiologic and Social Aspects of Aging (MESA) score
2. Pelvic floor assessment
Secondary outcome measures
Not provided at time of registration
Overall trial start date
13/11/2003
Overall trial end date
15/02/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
100+ patients
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
13/11/2003
Recruitment end date
15/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worcester Royal Infirmary
Worcester
WR5 1HN
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
Worcestershire Acute Hospitals NHS Trust (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