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
Professor JA Oldham
Scientific
Scientific
Centre for Rehabilitation Science
University of Manchester
Central Manchester Healthcare Trust
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 276 6672 |
|---|---|
| jackie.oldham@man.ac.uk |
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | An evaluation of pelvic floor muscle exercises and electrical muscle stimulation in patients with stress incontinence: a randomised, double-blind, controlled trial |
| Study objectives | To 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) studied | 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 |
| 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 study start date | 01/01/2000 |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | Added 12/01/2009: 27 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Rehabilitation Science
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Sponsor information
Action Medical Research (UK)
Charity
Charity
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
| Website | http://www.action.org.uk/ |
|---|---|
"ROR" |
https://ror.org/01wcqa315 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
