An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence

ISRCTN ISRCTN56654882
DOI https://doi.org/10.1186/ISRCTN56654882
Secondary identifying numbers AP0813
Submission date
01/03/2001
Registration date
01/03/2001
Last edited
16/01/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

JA Oldham
Scientific

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

Study information

Study designRandomised double-blind controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAn evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence: a randomised, double-blind, controlled trial
Study objectivesTo evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedStress incontinence
InterventionWomen 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 typeOther
Primary outcome measurePatients 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 measuresThe 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 study start date01/01/2000
Completion date31/12/2000

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexFemale
Target number of participantsAdded 12/01/2009: 27
Key inclusion criteria1. 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
Key exclusion criteriaAdded 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)
Date of first enrolment01/01/2000
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Rehabilitation Science
Manchester
M13 9WL
United Kingdom

Sponsor information

Funders

Funder type

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
action medical research for children, actionmedres, The National Fund for Research into Crippling Diseases, AMR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2000 Yes No
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