A randomized physiotherapy trial in patients with fecal incontinence: Design of the PhysioFIT-study

Department of Epidemiology, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands.
BMC Public Health (Impact Factor: 2.26). 12/2007; 7(1):355. DOI: 10.1186/1471-2458-7-355
Source: PubMed


Fecal 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 2 to 24% of the adult population. The prevalence increases with age in both men and women. Physiotherapy interventions are often considered a first-line approach due to its safe and non-invasive nature when dietary and pharmaceutical treatment fails or in addition to this treatment regime. Two physiotherapy interventions, 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.
A two-armed randomized controlled clinical trial will be conducted. One hundred and six 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 > or = 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. Skilled and registered physiotherapists experienced in women's health perform physiotherapy treatment. Twelve sessions are administered during three months according to a standardized protocol.
This section discusses the decision to publish a trial protocol, the actions taken to minimize bias and confounding in the design, explains the choice for two treatment groups, discusses the secondary goals of this study and indicates the impact of this trial on clinical practice.
The Netherlands Trial Register ISRCTN78640169.

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    • "RBT is used to increase the patient's ability to perceive the rectal distension. PFR interventions are noninvasive and inexpensive, require no sophisticated equipment and have hardly any adverse effects [10]. The aim of this systematic review is to evaluate the effectiveness of PFR in improving functional outcome after sphincter-preserving surgery for rectal cancer. "
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    ABSTRACT: Purpose Impaired functional outcome is common after a low anterior resection (LAR). Pelvic floor rehabilitation (PFR) might improve functional outcome after a LAR. The aim of this systematic review is to evaluate the effectiveness of PFR in improving functional outcome. Methods PubMed, Embase, and the Cochrane Library were searched using the terms fecal incontinence, colorectal neoplasm/surgery, LAR, rectal cancer, anterior resection syndrome, bowel habit, pelvic floor, training, therapy, physical therapy, rehabilitation and biofeedback. Of the 125 identified records, 5 articles were included. Results The 5 included studies reported on 321 patients, of which 286 patients (89%) underwent pelvic floor training. Three studies included patients with anterior resection syndrome after a LAR while the remaining studies included a series of patients after a LAR. Functional outcome was mostly assessed by using the Wexner incontinence scale. Quality of life was assessed in one study, and in three studies, rectal manometry was performed. After PFR, the functional outcome was improved in four studies, as was the quality of life. Conclusion This systematic review demonstrated that PFR is useful for improving the functional outcome after a LAR. The data are extracted from studies of limited quality, but the available evidence points to the effectiveness of the procedure.
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    ABSTRACT: To determine the psychometric properties of the total Vaizey score and its individual items. The study was conducted as part of a prospective cohort study assessing the outcome of pelvic floor rehabilitation in patients with fecal incontinence. One hundred ninety-four patients were analyzed, 53 of whom provided data on the global perceived effect (GPE) score. Pelvic floor rehabilitation resulted in a significant reduction of the total Vaizey score and most individual items. The total Vaizey scores changed in agreement with the GPE scores. The total Vaizey score was responsive, but some individual items yielded inconsistent results for three different measures. The test-retest reliability was adequate or excellent for six individual items and the total Vaizey score. The internal consistency was low for the total Vaizey score at baseline, in contrast to the follow-up and change scores. The estimates for the minimally important change (MIC) and smallest detectable change yielded moderately consistent results. An MIC of -5 points seemed preferable and yielded the lowest misclassification rate. More research is required to confirm conclusions on the psychometric properties of the total Vaizey score and its individual items, and to justify its use in research and routine clinical practice.
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    ABSTRACT: FI is a common and often devastating condition that adversely affects quality of life. Because it is widely underreported by patients, providers should screen for symptoms and refer affected patients accordingly. The initial evaluation includes a comprehensive history and targeted physical, and possibly administration of validated questionnaires and a bowel diary. The physical examination should include evaluation for systemic disorders as well as a focused rectal, pelvic, and perineal examination. Although the quality of ultrasound imaging is highly operator-dependent, this test is quick, inexpensive, and readily available, and remains the imaging procedure of choice for evaluating anatomic defects of the anal sphincter complex. MRI can be considered in certain patients, particularly when atrophy is suspected or if the EAS is poorly visualized on US. Manometry is the initial test of choice for anorectal function, although interpretation of manometric results is somewhat subjective. The clinical utility of EMG and PNTML is less clear, and these tests can cause discomfort and/or pain. In a clinical setting, these tests should only be performed when compromised nerve function is suspected, and surgery is planned. Given broad overlap in "normal" values on diagnostic testing, the work-up for FI should be individualized according to each clinical situation.
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