Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
25/07/2011
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

Mrs Sara Demain

ORCID ID

Contact details

Physiotherapy Department
Victoria Hospital
Friary Road
Lichfield
WS13 6QN
United Kingdom
+44 (0)1543 414 555 ext 2154

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

http://www.doh.gov.uk

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"

Publication citations

Additional files

Editorial Notes