Condition category
Urological and Genital Diseases
Date applied
15/08/2005
Date assigned
12/04/2006
Last edited
28/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sarah Lamb

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Physiotherapy Research Foundation (UK)

Sponsor details

The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom

Sponsor type

Charity

Website

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 Women’s 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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes