ISRCTN ISRCTN78640169
DOI https://doi.org/10.1186/ISRCTN78640169
Secondary identifying numbers NL952, NTR978
Submission date
27/06/2007
Registration date
27/06/2007
Last edited
31/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms E.M.J. Bols
Scientific

Maastricht University
Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone + 31 (0)43 388 2253
Email EMJ.Bols@epid.unimaas.nl

Study information

Study designRandomised, single blinded, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titlePhysiotherapy in Faecal Incontinence Trial
Study acronymPhysioFIT
Study objectivesThe combined therapy trial arm will have a larger reduction on the primary outcome measure.
Ethics approval(s)Received from the Medical Ethical Committee of the University Hospital Maastricht/Maastricht University on the 12th July 2006 (ref: MEC 06-3-048).
Health condition(s) or problem(s) studiedFaecal incontinence
InterventionTrial 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 typeOther
Primary outcome measureVaizey 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 measures1. 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 study start date01/09/2006
Completion date01/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants100
Total final enrolment80
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/09/2006
Date of final enrolment01/03/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Maastricht University
Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (UM) (The Netherlands)
University/education

Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Email EMJ.Bols@epid.unimaas.nl
Website http://www.unimaas.nl/default.asp?taal=en
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Industry

Medeco B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/12/2007 31/12/2020 Yes No
Results article results 01/09/2012 31/12/2020 Yes No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.