Re-education of the pelvic floor in women with urinary stress incontinence
| ISRCTN | ISRCTN59388318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59388318 |
| Protocol serial number | M0001127331 |
| Sponsor | Department of Health |
| Funder | The West London Research Network (WeLReN) (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 07/09/2015
- 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
Ms Libby Whelpton
Scientific
Scientific
Willesden Community Hospital
Harlesden Road
London
NW10 3RY
United Kingdom
| Phone | +44 (0)20 8451 8281 (ans) |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Re-education of the pelvic floor in women with urinary stress incontinence |
| Study objectives | One in four women suffer from Urinary Stress Incontinence (USI). The literature search suggests there is evidence from clinical experience and from research into the management of low back pain that retraining of the transversus abdominis muscle using real time ultrasound can facilitate correct tonic activity of the pelvic floor muscles (Richardson et al, 1999 and Critchely et al 2002). Studies so far of facilitation of the pelvic floor using RTUS have so far only been tested in healthy adult females (Sapsford, 2001). The aim of this study is to evaluate if by using Real Time Ultra Sound biofeedback (RTUS), a non-invasive technique, patients with urinary stress incontinence can learn more quickly how to co-contract the Transversus Abdominis muscle (TrA) and Pelvic Floor Muscles (PFM) in order to rehabilitate the pelvic floor and thereby reduce or eradicate the distressful symptoms of leakage. If RTUS can shorten the number of sessions required for patients to learn correctly how to co-contract the pelvic floor muscles this would enable physiotherapists to see a greater number of patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Urinary incontinence |
| Intervention | Participants will be randomised into two groups, one with RTUS over the abdominal muscles to facilitate instructions to activate co-contraction of the pelvic floor muscles, and the other without real time ultra sound biofeedback. Assessment parameters include a leakage diary, a one hour pad test, and subjective evaluation of life impact questionnaire (Kings Health Questionnaire). Each group will be assessed after 12 weeks training. |
| Intervention type | Other |
| Primary outcome measure(s) |
The study is to evaluate if by using RTUS, patients with urinary stress incontinence can learn more quickly how to co-contract the Transversus Abdominis muscle (TrA) and Pelvic Floor Muscles (PFM) in order to rehabilitate the pelvic floor and thereby reduce or eradicate the distressful symptoms of leakage. If RTUS can shorten the number of sessions required for patients to learn correctly how to co-contract the pelvic floor muscles this would enable physiotherapists to see a greater number of patients . |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 40 |
| Key inclusion criteria | Women between the ages of 30 and 65 with USI |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Willesden Community Hospital
London
NW10 3RY
United Kingdom
NW10 3RY
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
