Condition category
Urological and Genital Diseases
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
16/01/2009
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

Professor JA Oldham

ORCID ID

Contact details

Centre for Rehabilitation Science
University of Manchester
Central Manchester Healthcare Trust
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 6672
jackie.oldham@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AP0813

Study information

Scientific title

An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence: a randomised, double-blind, controlled trial

Acronym

Study hypothesis

To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Stress incontinence

Intervention

Women will be randomly allocated to one of the following groups:
1. Pelvic floor exercises alone
2. The new pattern of electrical stimulation alone
3. Pelvic floor exercises and the new pattern of electrical stimulation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patients were assessed pre, mid and post-treatment using:
1. Digital vaginal assessment of pelvic floor muscle strength using the modified Oxford
Grading Scale
2. Assessment of vaginal muscle strength and endurance using the PRS 9300 perineometer (Incare Medical Products, USA)
3. One-hour pad test as recommended by the International Continence Society (ICS)

Secondary outcome measures

The following were only used pre- and post-treatment:
1. Seven-day frequency/volume chart
2. 36-item Short Form Health Survey (SF-36)
3. The Incontinence Impact Questionnaire
4. The Urogenital Distress Inventory

Overall trial start date

01/01/2000

Overall trial end date

31/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females with stress incontinence between the ages of 18 and 70.

Added 12/01/2009:
2. Urodynamically proven stress incontinence
3. No neurological conditions diagnosed by consultant

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Added 12/01/2009: 27

Participant exclusion criteria

Added 12/01/2009:
1. Previous electrical stimulation for stress incontinence
2. Prolapse
3. Pregnancy
4. Pacemakers and cardiomyopathy
5. Abnormal urological/gynaecological findings
6. Urinary tract/vaginal infection
7. Recent pelvic floor surgery (within the last six months)

Recruitment start date

01/01/2000

Recruitment end date

31/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Rehabilitation Science
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Action Medical Research (UK)

Sponsor details

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Sponsor type

Charity

Website

http://www.action.org.uk/

Funders

Funder type

Charity

Funder name

Action Medical Research (UK)

Alternative name(s)

AMR

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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11128739

Publication citations

  1. Results

    Jeyaseelan SM, Haslam EJ, Winstanley J, Roe BH, Oldham JA, An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence: a randomized, double-blind, controlled trial., Clin Rehabil, 2000, 14, 6, 631-640.

Additional files

Editorial Notes