Chapter 6 150 The treatment protocol was comprised of intrarectal myofascial techniques, such as stretching the puborectalis muscle and myofascial release on identified trigger points in the pelvic floor to increase flexibility, release muscle tension and improve circulation. Manual techniques were tailored to the patient and based on results and findings of the diagnostic evaluation of the pelvic floor at every visit. To gain awareness, patients were taught how to contract and relax the pelvic floor muscles and were learned how to incorporate these into daily life. Breathing and pelvic floor muscle exercises were combined with EMG-biofeedback with an intra-anal probe (MAPLe®).27 The sessions were performed to increase awareness and monitor pelvic floor (dys)function.19,20 Patients with pelvic floor dyssynergia learned how to relax the pelvic floor during straining. If patients were unable to contract or relax the pelvic floor muscles, neuromuscular electrical stimulation was applied intra-anally during the biofeedback session. The home exercise program incorporated stretching the puborectalis muscle during the application of prescribed ointment, and pelvic floor muscle - and breathing exercises to improve relaxation. Furthermore, patients used thermotherapy with a heat blanket or sitz baths for relaxation.33 Additionally, information was provided with folders and videos to guide the home exercises. Patients who were assigned to postponed PFPT did not receive additional treatment besides their conservative measures until first follow-up at 8 weeks after inclusion. All medical data were collected at the clinic before entry into the trial database, data collection was facilitated by case record forms in Castor EDC.34 We recorded all adverse events and serious adverse events. Outcome measures The primary outcome was muscle tone at rest during EMG-registration of the pelvic floor before and after PFPT. Secondary outcomes contained clinical healing of the fissure (complete re-epithelisation), average pain intensity during defecation on a VAS-scale, improvement of pelvic floor muscle function and complaint reduction measured with the Proctoprom before and after PFPT. All outcomes were measured at baseline, at 8- and 20-week follow-up. Sample size The sample size of the study was based on the primary outcome of the study, the tone at rest during EMG registration of the pelvic floor. In preliminary studies we found
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