Condition category
Digestive System
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
28/06/2007
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

Ms E.M.J. Bols

ORCID ID

Contact details

Maastricht University
Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands
+ 31 (0)43 388 2253
EMJ.Bols@epid.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PhysioFIT

Study hypothesis

The combined therapy trial arm will have a larger reduction on the primary outcome measure.

Ethics approval

Received from the Medical Ethical Committee of the University Hospital Maastricht/Maastricht University on the 12th July 2006 (ref: MEC 06-3-048).

Study design

Randomised, single blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Faecal incontinence

Intervention

Trial arm 1: pelvic floor muscle training and rectal balloon training
Trial arm 2: pelvic floor muscle training

Both groups receive 12 treatments, each 35 minutes in duration, within three months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Vaizey incontinence score.

The primary and secondary outcome measures will be performed at baseline (prior to physiotherapy intervention), and 3, 6 and 12 months after time of inclusion. The 3 months follow-up after inclusion is done directly after the physiotherapy intervention.

Secondary outcome measures

1. Anorectal resting and squeeze pressure
2. Rectal capacity measurements
3. Anorectal sensation
4. Three-week diary results
5. Faecal Incontinence Quality of Life scale
6. PREFAB-score (adapted PRAFAB-score)
7. Global Perceived Effect (GPE-score)

The primary and secondary outcome measures will be performed at baseline (prior to physiotherapy intervention), and 3, 6 and 12 months after time of inclusion. The 3 months follow-up after inclusion is done directly after the physiotherapy intervention.

Overall trial start date

01/09/2006

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (aged 18 years and older)
2. Faecal Incontinence (FI) complaints due to different etiologies persisting for at least six months
3. Vaizey incontinence score of at least 12
4. Failure of conservative treatment (including dietary adaptations and pharmacological agents)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Patients diagnosed with an anorectal tumour within the past two years
2. Absent squeeze pressure of anal sphincter
3. Chronic diarrhoea (always fluid stool three or more times a day)
4. Overflow incontinence
5. Proctitis
6. Colitis ulcerosa
7. Crohn's disease
8. Soiling (defined as leakage of a minimal amount of faeces out of the anal canal)
9. Previous ileo-anal or colo-anal anastomosis and/or rectal prolapse in situ are excluded
10. Participants who received physiotherapy during the previous six months or who are intellectually and/or linguistically incapable to understand therapy are excluded as well

Recruitment start date

01/09/2006

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maastricht University
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (The Netherlands)

Sponsor details

Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands
EMJ.Bols@epid.unimaas.nl

Sponsor type

University/education

Website

http://www.unimaas.nl/default.asp?taal=en

Funders

Funder type

Industry

Funder name

Medeco B.V. (The Netherlands)

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

Publication citations

Additional files

Editorial Notes