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 measure
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 (if study stopped)
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
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 organizations
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
Basic results (scientific)
Publication list
2000 results in http://www.ncbi.nlm.nih.gov/pubmed/11128739
Publication citations
-
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.