5 Study protocol for a randomized controlled trial: PAF-study 131 The treatment consists of 5 sessions of a mean of 45-minutes in a period of 8 consecutive weeks. The treatment protocol is 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 are 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 are taught how to contract and relax the pelvic floor muscles and are learned how to incorporate these into daily life. Breathing and pelvic floor muscle exercises are combined with surface electromyography (s-EMG)-biofeedback with an intra-anal probe (MAPLe®).37 The sessions are performed to increase awareness and monitor pelvic floor (dys)function.21,30,42,43 Patients with pelvic floor dyssynergia learn how to relax the pelvic floor during straining. If patients are unable to contract or relax the pelvic floor, neuromuscular electrical stimulation will be applied intra-anally during the biofeedback session. The home exercise program incorporates stretching the puborectalis muscle during the application of ointment, and pelvic floor muscle - and breathing exercises to improve relaxation. Furthermore, patients use thermotherapy with a heat blanket or sitz baths for relaxation.44 Additionally, information will be provided with folders and videos to guide the home exercises. Therapy compliance is encouraged because the daily home exercises determine to a great extent the success rate.45 The collaborating pelvic floor physical therapist will evaluate the patients’ compliance of home exercises at every visit. Patients who are assigned to postponed PFPT will not receive additional treatment besides the use of ointment and fibres/laxatives until first follow-up at 8 weeks after inclusion. Harms Adverse Events (AE) are defined as any undesirable experience occurring to a subject during the study, whether considered related to the trial procedure or to an already existing condition. All (serious) adverse events suspected unexpected serious adverse reactions (SUSAR) and any other significant problems are reported to the Medical Ethics Review Committee (MERC) using an online submission system. All adverse events will be described in the final analysis. No adverse events are expected since PFPT including biofeedback and/or neuromuscular electrical stimulation is usual care in the Netherlands. The expected burden for the participants is very low.
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