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
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