Chapter 6 148 We hypothesised that treatment with PFPT including biofeedback in addition to regular conservative management will result in an improvement of pelvic floor muscle tone and function, pain, healing of the fissure and increased satisfaction in patients with CAF and concomitant pelvic floor dysfunction. Materials and Methods Study design The PAF-study is a single-centre, parallel, randomized controlled trial. This superiority trial was designed to detect a difference of PFPT including surface electromyographic biofeedback (EMG) versus no PFPT at first follow-up. The design involved allocation of all appropriate consecutive patients with CAF and pelvic floor dysfunction. Eligible patients were randomly assigned, after providing written informed consent, to an intervention group receiving 8 weeks of PFPT including EMG-biofeedback or assigned to a control group receiving postponed PFPT. Baseline and follow-up Baseline and follow-up appointments at 8 and 20 weeks from baseline with the surgeon and principal investigator, an experienced pelvic floor physical therapist, consisted of a clinical examination provided through inspection to investigate the healing of the fissure. If necessary, proctoscopy was performed to exclude other pathology. Resting anal sphincter pressure, pelvic floor muscle tone and function were measured by a careful digital rectal examination and scored as decreased, normal and increased.25,26 Pelvic floor dysfunction was defined by the presence of dyssynergia and/or increased pelvic floor muscle tone. Besides that, pelvic floor muscle tone was measured with EMG (μV) 25 with an intra-anal probe (MAPLe,® Novuqare Pelvic Health B.V. CE 0344, Rosmalen, the Netherlands). This probe has a matrix of 24 electrodes and is capable of registering EMG-activity nearest to the individual muscles of the pelvic floor during diagnosis and treatment. The MAPLe® system is validated for its purpose.27 In addition, muscle tone of the EAS was measured with EMG (circle 1, MAPLe®). Dyssynergia was detected by digital rectal examination and balloon expulsion test.28,29 The balloon expulsion test provides an assessment of the patient’s ability to evacuate artificial stool during simulated defecation. A non-sterile disposable balloon (BARD,
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