Group treatment: an acceptable and effective method of physiotherapy provision for female urinary incontinence?

ISRCTN	ISRCTN16772662
DOI	https://doi.org/10.1186/ISRCTN16772662
Protocol serial number	PRF/01/2
Sponsor	Physiotherapy Research Foundation (UK)
Funder	Physiotherapy Research Foundation (PRF) - 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

University of Warwick
Room A1.04 Medical School Building
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Symptom severity questionnaire (SSI) (Black et al., 1996) 2. Incontinence-related quality of life (IQOL) (Uebersax et al., 1995)
Key secondary outcome measure(s)	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
Completion date	30/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Warwick

Coventry
CV4 7AL
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	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