Physiotherapy in Faecal Incontinence Trial
ISRCTN | ISRCTN78640169 |
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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
Scientific
Maastricht University
Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands
Phone | + 31 (0)43 388 2253 |
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EMJ.Bols@epid.unimaas.nl |
Study information
Study design | Randomised, single blinded, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/09/2006 |
Completion date | 01/03/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 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
6200 MD
Netherlands
Sponsor information
University Maastricht (UM) (The Netherlands)
University/education
University/education
Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands
EMJ.Bols@epid.unimaas.nl | |
Website | http://www.unimaas.nl/default.asp?taal=en |
https://ror.org/02jz4aj89 |
Funders
Funder type
Industry
Medeco B.V. (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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.