Group treatment: an acceptable and effective method of physiotherapy provision for female urinary incontinence?
| ISRCTN | ISRCTN16772662 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16772662 |
| Secondary identifying numbers | PRF/01/2 |
- Submission date
- 15/08/2005
- Registration date
- 12/04/2006
- Last edited
- 28/09/2009
- 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
Prof Sarah Lamb
Scientific
Scientific
University of Warwick
Room A1.04 Medical School Building
Gibbet Hill Campus
Coventry
CV4 7AL
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 | Treatment |
| Scientific title | |
| Study acronym | INCON |
| Study objectives | The aims of this study are to: 1. Compare the effectiveness of group versus individual treatments in terms of quality of life and cost effectiveness in the UK health care setting 2. Establish patients' preferences for group versus individual physiotherapy for the management of female urinary incontinence (FUI) 3. Identify patients' concerns with regards to participation in group settings, and changes in preferences as a result of treatment |
| Ethics approval(s) | This study received an ethics approval before participant recruitment. |
| Health condition(s) or problem(s) studied | Stress incontinence and/or urge incontinence |
| Intervention | Group: three group sessions for an hour each over a three-week period, with a maximum of 10 women in each treatment group. Individual: an assessment given and any of the techniques used in the group sessions were taught on a one to one basis. A maximum of three sessions of 1-hour duration were permissible. |
| Intervention type | Other |
| Primary outcome measure | 1. Symptom severity questionnaire (SSI) (Black et al., 1996) 2. Incontinence-related quality of life (IQOL) (Uebersax et al., 1995) |
| Secondary outcome measures | 1. Cost related to treatment attendance and complementary therapies and other products 2. The need for further physiotherapy 3. General practitioner (GP) utilisation and surgery will be recorded although not reported here |
| Overall study start date | 12/08/2002 |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Females aged 18 years or over 2. Ability to understand and capability of giving written informed consent with an interpreter if necessary 3. Clinical symptoms of stress and/or urge incontinence |
| Key exclusion criteria | 1. Pregnancy 2. Recent pelvic surgery (less than three months) 3. History of pelvic malignancy 4. Current urinary infection 5. Grade III prolapse 6. Diseases of the central nervous system (e.g. multiple sclerosis, cerebrovascular accident) 7. Acute mental illness and dementia 8. Previous physiotherapy for incontinence within the last 12 months |
| Date of first enrolment | 12/08/2002 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Warwick
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
Physiotherapy Research Foundation (UK)
Charity
Charity
The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom
"ROR" |
https://ror.org/04sn78z72 |
|---|
Funders
Funder type
Charity
Physiotherapy Research Foundation (PRF) - PRF/01/2
No information available
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 | 01/04/2008 | Yes | No | |
| Results article | interview study results | 10/09/2009 | Yes | No | |
| Results article | results | 14/09/2009 | Yes | No |
