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

BMC Public Health, Dec 2007

Background 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. Methods/Design 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 ≥ 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. Discussion 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. Trial registration The Netherlands Trial Register ISRCTN78640169.

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

BMC Public Health A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study Esther MJ Bols 1 2 Bary CM Berghmans 0 Erik JM Hendriks 1 2 4 Rob A de Bie 1 2 4 Jarno Melenhorst 0 3 Wim G van Gemert 0 3 Cor GMI Baeten 0 3 0 Pelvic care Center Maastricht, University Hospital Maastricht , PO Box 5800, 6202 AZ Maastricht , The Netherlands 1 Caphri research institute, Maastricht University , The Netherlands 2 Department of Epidemiology, Maastricht University , PO Box 616, 6200 MD Maastricht , The Netherlands 3 Department of Surgery, University Hospital Maastricht , PO Box 5800, 6202 AZ Maastricht , The Netherlands 4 Centre for Evidence Based Physiotherapy, Maastricht University , PO Box 616, 6200 MD Maastricht , The Netherlands Background: 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. Methods/Design: 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 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. Discussion: 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. Trial registration: The Netherlands Trial Register ISRCTN78640169. - Background Background of fecal incontinence Fecal incontinence (FI) is a major health care problem, that is particularly embarrassing and affects about 2 to 24% of the adult population, increasing to 47% in the institutionalized elderly [1-7]. The actual prevalence is likely to be higher due to the common underreporting of FI as a result of patients' embarrassment to visit a physician or unawareness of possible treatment options [8]. FI can be defined as the recurrent involuntary excretion of feces in inappropriate places or at inappropriate times [7], and covers a wide spectrum from involuntary but recognized passage of gas, liquid, or solid stool (urge incontinence) to unrecognized anal leakage of mucus, fluid, or stool (passive incontinence) [9]. Fecal continence is based on a combined interplay of sensory, motoric and reservoir functions. Incontinence occurs if one or more of these components fail and when compensatory mechanisms fall short. Obstetric trauma is one of the major causes of FI in women. Several colorectal, urological or gynaecological interventions can cause FI as well. Specific neurological diseases associated with FI include diabetes, multiple sclerosis, Parkinson's disease, stroke, and spinal cord injury. FI is often thought to be associated with older people, as a natural aspect of ageing. Recently, it has been estimated that 6% of the persons aged 60 years and older suffer from involuntary loss of feces and 3% from involuntary loss of both feces and urine [8]. In addition, the prevalence of FI will increase in the next fifteen years due to double ageing. However, younger patients are often affected as well [1]. FI interacts with multiple aspects of daily life resulting in a number of difficulties; having to stay at home near a toilet, having to avoid social contacts including relationships or sexual contact, havin (...truncated)


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Esther MJ Bols, Bary CM Berghmans, Erik JM Hendriks, Rob A de Bie, Jarno Melenhorst, Wim G van Gemert, Cor GMI Baeten. A randomized physiotherapy trial in patients with fecal incontinence: design of the PhysioFIT-study, BMC Public Health, 2007, pp. 355, 7, DOI: 10.1186/1471-2458-7-355