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ISRCTN
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ISRCTN56654882
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DOI
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10.1186/ISRCTN56654882
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence
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Scientific title
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An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence: a randomised, double-blind, controlled trial
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Acronym
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N/A
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Serial number at source
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AP0813
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Study hypothesis
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To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double-blind controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stress incontinence
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/01/2000
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Anticipated end date
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31/12/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Added 12/01/2009: 27
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Interventions
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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
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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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
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Sources of funding
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Action Medical Research (UK)
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Trial website
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Publications
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2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11128739
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Contact name
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Professor
JA
Oldham
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Address
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Centre for Rehabilitation Science
University of Manchester
Central Manchester Healthcare Trust
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9WL
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Country
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United Kingdom
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Tel
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+44 (0)161 276 6672
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Fax
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+44 (0)161 276 6672
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Email
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jackie.oldham@man.ac.uk
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Sponsor
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Action Medical Research (UK)
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Address
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Vincent House
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City/town
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Horsham West Sussex
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Zip/Postcode
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RH12 2DP
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Country
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United Kingdom
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Tel
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+44 (0)1403 210 406
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Fax
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+44 (0)1403 210 541
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Email
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info@actionresearch.co.uk
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Sponsor website:
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http://www.action.org.uk/
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Date applied
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01/03/2001
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Last edited
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16/01/2009
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Date ISRCTN assigned
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01/03/2001
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