Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PRF/01/2
Study information
Scientific title
Acronym
INCON
Study hypothesis
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
This study received an ethics approval before participant recruitment.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
12/08/2002
Overall trial end date
30/04/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant 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
Recruitment start date
12/08/2002
Recruitment end date
30/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Warwick
Coventry
CV4 7AL
United Kingdom
Funders
Funder type
Charity
Funder name
Physiotherapy Research Foundation (PRF) - PRF/01/2
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Dissemination to a clinical group: Pepper J, Lamb SE, Doughty G, Fereday Smith J (2003) Group treatment: An acceptable & effective method of physiotherapy for bladder problems? Journal of the Association of Chartered Physiotherapists in Womens Health; 93: 15-18
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18274881
3. 2009 interview study results in http://www.ncbi.nlm.nih.gov/pubmed/19744315
4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19751517
Publication citations
-
Results
Haywood KL, Garratt AM, Lall R, Smith JF, Lamb SE, EuroQol EQ-5D and condition-specific measures of health outcome in women with urinary incontinence: reliability, validity and responsiveness., Qual Life Res, 2008, 17, 3, 475-483, doi: 10.1007/s11136-008-9311-z.
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Interview study results
Griffiths F, Pepper J, Jørstad-Stein EC, Smith JF, Hill L, Lamb SS, Group versus individual sessions delivered by a physiotherapist for female urinary incontinence: an interview study with women attending group sessions nested within a randomised controlled trial., BMC Womens Health, 2009, 9, 25, doi: 10.1186/1472-6874-9-25.
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Results
Lamb SE, Pepper J, Lall R, Jørstad-Stein EC, Clark MD, Hill L, Fereday-Smith J, Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence., BMC Womens Health, 2009, 9, 26, doi: 10.1186/1472-6874-9-26.