6 PAF-study: results of a randomized controlled trial 149 Covington, USA) was filled with 50ml water or until the patient felt an urge to defecate. Evacuation of the balloon after more than 2 minutes was seen as impossible to expulse and was considered dyssynergic defecation.28 The balloon expulsion test was performed at baseline and 20-week follow-up by the nurse in our clinic. Patients were requested to fill in 2 validated self-administered questionnaires at baseline, and at 8- and 20-week follow-up. To quantify the average intensity of pain during defecation, a visual analog scale (VAS) from 0 (no pain) to 10 (most intense pain) was used.30 The Proctoprom, a patient related outcome measurement was used to assess the impact of proctologic complaints on different aspects of a patient’s life and to evaluate the effect of treatment.31 Participants Men and women aged 18 years or older presenting CAF and pelvic floor dysfunction were recruited at the Proctos Clinic in the Netherlands from December 2018 until July 2021. CAF was defined as a longitudinal ulcer with symptoms presenting longer than 6 weeks or recurrent fissures. All patients had failed conservative treatment with fiber and/or laxatives and ointment (diltiazem or isosorbide dinitrate) used for at least 6 weeks and with accurate instructions about how to apply. All patients had sufficient understanding of the Dutch language (reading and writing) and were able to complete online questionnaires. We considered patients who were not able to undergo a digital rectal examination, not eligible for this study. Patients with an abscess or fistula, Crohn’s disease or ulcerative colitis, anorectal malignancy, prior rectal radiation, and pregnancy were excluded from the study. Interventions At baseline, patients in both groups received information about the pelvic floor and related symptoms, explanations about relevant anatomy and defecation (patho) physiology, behavioural modifications, and lifestyle advice. All patients continued their conservative measures including the use of ointment (diltiazem or isosorbide dinitrate). PFPT consisted of 5 face-to-face appointments of a mean of 45 minutes in a period of 8 consecutive weeks, using a treatment protocol.32 Patients were referred to an extramural private practice, preferably nearby patients’ home address.
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