Condition category
Urological and Genital Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
07/10/2009
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

Dr C McGrother

ORCID ID

Contact details

Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 6TP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9410491

Study information

Scientific title

Acronym

Study hypothesis

To investigate the efficacy of standard pelvic floor therapies designed to strengthen pelvic floor and reduce incontinence in women with sphincteric incontinence.

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

Incontinence

Intervention

1. Vaginal cone therapy - the use of vaginal cones to build up pelvic floor contractions and to provide feedback about proper contraction.
2. Pelvic floor therapy - instructions on the contraction of the pelvic floor together with vaginal assessment to confirm proper contraction and bio-feedback.
3. Pelvic floor awareness - simple verbal and written instructions on contraction of the pelvic floor.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinical assessment using urinary diaries and 24 h home pad test and 1 h ICS pad test. Digital, perineometry and urodynamic evaluation of the pelvic floor and urinary sphincter.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1997

Overall trial end date

31/03/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Failed conservative therapies for urinary dysfunction (nursing interventions) in women
2. Urodynamically proven genuine stress incontinence

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

345

Participant exclusion criteria

1. Pregnancy
2. Malignancy
3. Fistula

Recruitment start date

01/06/1997

Recruitment end date

31/03/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Epidemiology and Public Health
Leicester
LE1 6TP
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17034605

Publication citations

  1. Results

    Williams KS, Assassa RP, Gillies CL, Abrams KR, Turner DA, Shaw C, Haslam J, Mayne C, McGrother CW, , A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence., BJU Int., 2006, 98, 5, 1043-1050, doi: 10.1111/j.1464-410X.2006.06484.x.

Additional files

Editorial Notes