Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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 Paul Moran

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes