Physiotherapy in Faecal Incontinence Trial

ISRCTN	ISRCTN78640169
DOI	https://doi.org/10.1186/ISRCTN78640169
Protocol serial number	NL952, NTR978
Sponsor	University Maastricht (UM) (The Netherlands)
Funder	Medeco B.V. (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised, single blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Physiotherapy in Faecal Incontinence Trial
Study acronym	PhysioFIT
Study objectives	The 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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	100
Total final enrolment	80
Key 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)
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Maastricht University

Maastricht
6200 MD
Netherlands

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