A randomised controlled trial of educational group sessions and conventional individual management in the physiotherapeutic treatment of female urinary incontinence (FUI)
| ISRCTN | ISRCTN23418270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23418270 |
| Protocol serial number | 593 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive West Midlands (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 09/08/2021
- 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
Mrs Sara Demain
Scientific
Scientific
Physiotherapy Department
Victoria Hospital
Friary Road
Lichfield
WS13 6QN
United Kingdom
| Phone | +44 (0)1543 414 555 ext 2154 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled trial of educational group sessions and conventional individual management in the physiotherapeutic treatment of female urinary incontinence (FUI) |
| Study objectives | To test the hypothesis that the new treatment approach of an educational group has a significantly greater effect on: 1. Physical symptoms 2. Life quality in women with FUI than the individual home help method |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and genital diseases: Incontinence |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure(s) |
Pad test, pelvic floor muscle power, Incontinence report questionnaire, Symptom severity Index and Visual Analogue Scale. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Total final enrolment | 44 |
| Key inclusion criteria | All female patients aged 18-75 years with a clinical diagnosis of stress and/or urge incontinence will be considered for inclusion. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1996 |
| Date of final enrolment | 01/03/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Physiotherapy Department
Lichfield
WS13 6QN
United Kingdom
WS13 6QN
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 | 01/05/2001 | 09/08/2021 | Yes | No |
Editorial Notes
09/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
