Evaluation of the efficacy of pelvic floor therapies in the management of genuine stress incontinence
| ISRCTN | ISRCTN28188933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28188933 |
| Protocol serial number | G9410491 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Epidemiology and Public Health
Leicester
LE1 6TP
United Kingdom
LE1 6TP
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2006 | Yes | No |
