Chapter 7 174 CAF and pelvic floor dysfunction. Eligible patients were randomly assigned, after providing written informed consent to an intervention group receiving 8 weeks of PFPT or assigned to postponed PFPT (1:1 allocation). Participants Men and women aged 18 years or older presenting CAF and pelvic floor dysfunction were recruited by the surgeon at the Proctos Clinic in the Netherlands. CAF was defined as a longitudinal ulcer in the squamous epithelium with one or more signs of chronicity including hypertrophied anal papilla, sentinel pile and exposed internal sphincter muscle. Patients had fissure complaints of more than 6 weeks and all patients failed conservative treatment with fibers and/or laxatives and had applied the ointment (diltiazem or isosorbide di-nitrate) internally for at least 6 weeks. Pelvic floor dysfunction was defined by the presence of dyssynergia and/or increased pelvic floor muscle tone. All patients had sufficient understanding of the Dutch language (reading and writing) and were able to complete the online questionnaires. Patients who were not able to undergo a digital rectal examination, patients presenting an abscess or fistula, Crohn’s disease or ulcerative colitis, anorectal malignancy, previous rectal radiation and pregnancy were excluded from the trial. Physical examination and questionnaires The diagnosis of CAF was based on medical history taken and a thorough local inspection of the anus. Resting anal sphincter pressure was measured by a careful digital rectal examination and scored as decreased, normal and increased.15 Pelvic floor dysfunction was defined by the presence of dyssynergia and/or increased pelvic floor muscle tone. Pelvic floor muscle tone was measured with a digital rectal examination16 and surface electromyography (μV)16 with an intra-anal probe (MAPLe,®Novuqare Pelvic Health B.V. CE 0344, Rosmalen, the Netherlands), which is validated for its purpose.17 Pelvic floor dyssynergia was detected by digital rectal examination 18 and balloon expulsion test.19 If necessary, proctoscopy was performed to exclude other pathology. To access the impact of global QoL, the validated Dutch version of Short-Form RAND-36, Health Status Inventory, version 2.13 was used. The RAND-36 consists of 36 items and 9 subscales: physical functioning, bodily pain, role limitation due to physical health problems, vitality, general health perception,
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