A prospective randomised controlled trial of pelvic floor exercises plus biofeedback versus pelvic floor exercises alone in treating stress urinary incontinence

ISRCTN ISRCTN37726767
DOI https://doi.org/10.1186/ISRCTN37726767
Secondary identifying numbers N0282131250
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
05/12/2014
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paul Moran
Scientific

Worcester Royal Infirmary
Ronkswood Branch
Newtown Road
Worcester
WR5 1HN
United Kingdom

Study information

Study designRandomised prospective assessment and cross over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA prospective randomised controlled trial of pelvic floor exercises plus biofeedback versus pelvic floor exercises alone in treating stress urinary incontinence
Study objectivesAssess the effectiveness of biofeedback with pelvic floor exercises compared to pelvic floor exercises alone in women with stress urinary incontinence.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Urinary incontinence
InterventionBiofeedback with pelvic floor exercises compared to pelvic floor exercises alone
Intervention typeOther
Primary outcome measure1. Quality of life. Medical Epidemiologic and Social Aspects of Aging (MESA) score
2. Pelvic floor assessment
Secondary outcome measuresNot provided at time of registration
Overall study start date13/11/2003
Completion date15/02/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants100+ patients
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment13/11/2003
Date of final enrolment15/02/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Worcester Royal Infirmary
Worcester
WR5 1HN
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

Worcestershire Acute Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan