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: 2.08). 01/2007; 7:355. DOI:10.1186/1471-2458-7-355
Source: PubMed

ABSTRACT 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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    ABSTRACT: It is unclear which patients with fecal incontinence (FI) are likely to benefit from physiotherapy treatment, which is relevant for medical decision making and patient counseling. This study aimed to identify patient characteristics predicting a favorable outcome of physiotherapy. Eighty patients with FI, with a mean age of 59.3 (SD ± 11.9), were recruited at the Maastricht University Medical Centre and enrolled in a randomized controlled trial, which assessed the effect of adding rectal balloon training to pelvic floor muscle training. Treatment groups were combined for prediction modeling. Candidate predictors were obtained from demographics, medical history, physical examination, baseline tests, questionnaires, and physiotherapy diagnostics. Favorable outcome was defined as a combination of: (i) Vaizey score reduction ≥ 5 points, and (ii) "slightly" to "very much improved" on the nine-point global perceived effect score. Predictors were identified by univariable and multivariable logistic regression analysis. Thirty-seven patients (46.3%) had a favorable outcome. Multivariable analysis showed that longer time since FI onset appeared to be associated with an unfavorable outcome (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.47-1.00; P = 0.05), whereas the use of constipating medication (OR, 3.79; CI, 0.99-14.51; P = 0.05), any obstetric factor (OR, 2.15; CI, 0.94-4.89; P = 0.07), and experiencing minor embarrassment (OR, 2.12; CI, 1.10-4.09; P = 0.03) predicted a favorable outcome. The small subset of identified predictors for a favorable outcome may be relevant in patient counseling and targeting physiotherapy treatment more efficiently, especially as they are available early in the diagnostic process.
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    ABSTRACT: INTRODUCTION AND HYPOTHESIS: This study aims to assess the responsiveness and interpretability of the Vaizey score, Wexner score, and the Fecal Incontinence Quality of Life Scale (FIQL) for use in the evaluation of patients with fecal incontinence (FI). METHODS: Eighty patients with FI with a mean age of 59.3 (SD ± 11.9) were enrolled in a randomized controlled trial. The patient-reported outcomes were tested for internal and external responsiveness, longitudinal construct validity, and interpretability. RESULTS: All total scores proved to have both adequate to excellent responsiveness and longitudinal construct validity, and changes were in agreement with subjective improvement. Due to variability in minimally important change estimates (Vaizey score -5 to -3, Wexner score -3 to -2, FIQL 1.1 to 1.2), they should be used as indicators. All patient-reported outcomes showed psychometric or practical limitations. CONCLUSIONS: The instruments available to date to evaluate severity and quality of life in FI do not yet attain the highest levels of psychometric soundness. As the focus of patients may differ from that of physicians, it is recommended that several measures should be included for evaluation. So far, there are suggestions that the Wexner score is most suitable for severity assessment and the FIQL for evaluating quality of life.
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