Chapter 9 218 on pelvic floor muscle tone and function, pain, healing of the fissure, quality of life and complaint reduction in patients with CAF. Patients with CAF and pelvic floor dysfunction will be recruited by surgeons of the Proctos Clinic. Exclusion criteria included abscess, fistula, Crohn’s disease, ulcerative colitis, anorectal malignancy, prior rectal radiation, and pregnancy. A total of 140 patients are randomized for either PFPT or postponed treatment of PFPT. The primary outcome is tone at rest during electromyographic registration of the pelvic floor before and after therapy. Secondary outcomes consist of healing of the fissure, pain ratings, improvement of pelvic floor function, complaint reduction and quality of life. Primary and secondary endpoints are measured at 8 -and 20 week and at 1-year follow-up. Chapter 6 Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial This chapter outlines the results of the PAF-study at 8- and 20-week follow-up. Between December 2018 and July 2021, at the Proctos Clinic in the Netherlands, patients with chronic anal fissure and pelvic floor dysfunction were randomly assigned to an intervention group, receiving 8 weeks of PFPT including electromyographic biofeedback or assigned to a control group receiving postponed PFPT. Endpoints were measured at 8- and 20-week follow-up. 140 patients were included in the study, 68 men (48.6%) and 72 women (51.4%) with a mean age of 44,5 ±11.1 (range 19-79) years. Mean resting electromyographic values of the pelvic floor in the intervention group significantly improved from pre-to post-treatment (p<0.001) and relative to controls (mean estimated difference between groups -1.88 µV; 95% CI, -2.49 to -1.27 (p<0.001) at first follow-up and remained significant from baseline at 20-week follow-up (p<0.001). The intervention group performed better compared to the control group on all secondary outcomes i.e., healing of the fissure (55.7% of the patients vs 21.4% in control, pain ratings (p<0.001), diminished dyssynergia (p<0.001), complaint reduction (p<0.001) and decrease of pelvic floor muscle tone (p<0.05) at first follow-up. The findings of this study provide strong evidence that PFPT is effective in patients with CAF and pelvic floor dysfunction and supports its recommendation as adjuvant treatment besides regular conservative treatment.
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