A prospective randomised controlled trial of pelvic floor exercises plus biofeedback versus pelvic floor exercises alone in treating stress urinary incontinence
| ISRCTN | ISRCTN37726767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37726767 |
| Protocol serial number | N0282131250 |
| Sponsor | Department of Health |
| Funder | Worcestershire Acute Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 05/12/2014
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Paul Moran
Scientific
Scientific
Worcester Royal Infirmary
Ronkswood Branch
Newtown Road
Worcester
WR5 1HN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised prospective assessment and cross over trial |
| Secondary study design | Randomised cross over trial |
| Scientific title | A prospective randomised controlled trial of pelvic floor exercises plus biofeedback versus pelvic floor exercises alone in treating stress urinary incontinence |
| Study objectives | Assess the effectiveness of biofeedback with pelvic floor exercises compared to pelvic floor exercises alone in women with stress urinary incontinence. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Urinary incontinence |
| Intervention | Biofeedback with pelvic floor exercises compared to pelvic floor exercises alone |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Quality of life. Medical Epidemiologic and Social Aspects of Aging (MESA) score |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 13/11/2003 |
| Date of final enrolment | 15/02/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Worcester Royal Infirmary
Worcester
WR5 1HN
United Kingdom
WR5 1HN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
