Evaluation of the efficacy of pelvic floor therapies in the management of genuine stress incontinence
| ISRCTN | ISRCTN28188933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28188933 |
| Secondary identifying numbers | G9410491 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 07/10/2009
- 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
Dr C McGrother
Scientific
Scientific
Department of Epidemiology and Public Health
University of Leicester
22-28 Princess Road West
Leicester
LE1 6TP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To investigate the efficacy of standard pelvic floor therapies designed to strengthen pelvic floor and reduce incontinence in women with sphincteric incontinence. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Incontinence |
| Intervention | 1. Vaginal cone therapy - the use of vaginal cones to build up pelvic floor contractions and to provide feedback about proper contraction. 2. Pelvic floor therapy - instructions on the contraction of the pelvic floor together with vaginal assessment to confirm proper contraction and bio-feedback. 3. Pelvic floor awareness - simple verbal and written instructions on contraction of the pelvic floor. |
| Intervention type | Other |
| Primary outcome measure | Clinical assessment using urinary diaries and 24 h home pad test and 1 h ICS pad test. Digital, perineometry and urodynamic evaluation of the pelvic floor and urinary sphincter. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/1997 |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 345 |
| Key inclusion criteria | 1. Failed conservative therapies for urinary dysfunction (nursing interventions) in women 2. Urodynamically proven genuine stress incontinence |
| Key exclusion criteria | 1. Pregnancy 2. Malignancy 3. Fistula |
| Date of first enrolment | 01/06/1997 |
| Date of final enrolment | 31/03/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 6TP
United Kingdom
LE1 6TP
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- 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 | 01/11/2006 | Yes | No |
