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Physiotherapy in Fecal Incontinence Trial


- candidate number2588
- NTR NumberNTR978
- ISRCTNISRCTN78640169
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR16-mei-2007
- Secondary IDs 
- Public TitlePhysiotherapy in Fecal Incontinence Trial
- Scientific TitleA randomized controlled trial of physiotherapy in patients with fecal incontinence
- ACRONYMPhysioFIT
- hypothesisThe combined therapy trial arm will have a larger reduction on the primary outcome measure
- Healt Condition(s) or Problem(s) studiedFecal incontinence
- Inclusion criteria1. Adults (aged 18 years and older); 2. 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)
- Exclusion criteria1. Patients diagnosed with an anorectal tumor within the past two years; 2. Absent squeeze pressure of anal sphincter; 3. Chronic diarrhea (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 feces 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate1-mrt-2010
- Target number of participants100
- InterventionsTrial 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
- Primary outcomeVaizey incontinence score
- Secondary outcome1. Anorectal resting and squeeze pressure; 2. Rectal capacity measurements; 3. Anorectal sensation; 4. Three-weekdiary results; 5. Fecal Incontinence Quality of Life scale; 6. PREFAB-score (adapted PRAFAB-score); 7. Global Perceived Effect (GPE-score).
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES EMJ Bols
- CONTACT for SCIENTIFIC QUERIESProf. Dr. R.A. Bie, de
- Sponsor/Initiator University Maastricht (UM), Department of Epidemiology, Pelvic care Center Maastricht
- Funding
(Source(s) of Monetary or Material Support)
Medeco B.V.
- Publications
- Brief summaryFecal incontinence (FI) is defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times. It is a major and highly embarrassing health care problem, which affects about two to 24% of the adult population. The prevalence increases with age in both men and women. Fecal (in)continence is dependent on sensory, motoric and reservoir functions. Often, a multifactorial cause is present. Initially, treatment consists of dietary adaptations and pharmaceutical interventions. In case of failure, physiotherapeutic interventions are often considered a first-line approach due to its safe and non-invasive nature. Two physiotherapeutic treatments, rectal balloon training (RBT) and pelvic floor muscle training (PFMT) are widely used in the management of FI. However, their effectiveness remains uncertain since well-designed trials on the effectiveness of RBT and PFMT versus PFMT alone in FI have never been published. Therefore, well-designed research comparing RBT and PFMT versus PFMT alone is needed to manage this highly embarrassing and socially restricting disorder. A two-armed randomized controlled clinical trial will be conducted. One hundred patients are randomized to receive either PFMT combined with RBT or PFMT alone. Physicians in the University Hospital Maastricht include eligible participants. Inclusion criteria are (1) adults (aged 18 years), (2) with fecal incontinence complaints due to different etiologies persisting for at least six months, (3) having a Vaizey incontinence score of at least 12, (4) and failure of conservative treatment (including dietary adaptations and pharmacological agents). Baseline measurements consist of the Vaizey incontinence score, medical history, physical examination, medication use, anorectal manometry, rectal capacity measurement, anorectal sensation, anal endosonography, defecography, symptom diary, Fecal Incontinence Quality of Life scale (FIQL) and the PREFAB-score. Follow-up measurements are scheduled at three, six and 12 months after inclusion. Physiotherapeutic treatment is performed by skilled and registered pelvic therapists. Twelve physiotherapeutic treatments are administered during three months according to a standardized protocol. The results of this trial will be used for recommendations in the physiotherapy guideline for fecally incontinent patients, developed according to the method of clinical practice guideline development of the Royal Dutch Physiotherapy Association (KNGF).
- Main changes (audit trail)
- RECORD16-mei-2007 - 3-jul-2007


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