Pelvic floor physical therapy in patients with chronic anal fissure: Long term follow-up of a randomized controlled trial

Abstract

Abstract Background Chronic anal fissure is a common benign anorectal disease with a high recurrence rate. Pelvic floor physical therapy has been proven effective in the short-term management in patients with chronic anal fissure and pelvic floor dysfunction (PAF-trial). The aim of this study was to determine the outcomes of the PAF-trial and fissure recurrence in patients who completed the 2 months of pelvic floor physical therapy at 1-year follow-up.Methods Electromyographic registration of the pelvic floor, digital rectal examination, visual analog scales, patient related outcome measurements and quality of life were assessed at baseline, and at 1 year after inclusion. The primary outcome was muscle tone at rest during electromyographic registration of the pelvic floor at baseline and at 1-year follow-up. Secondary outcomes contained fissure recurrence, pain ratings, pelvic floor dysfunction, complaint reduction measured with a proctology specific patient-reported outcome measurement and quality of life. Results The treatment protocol was followed by 137 patients. 97 patients (71%) completed the 1-year follow-up, 48 women (49.5%) and 49 men (50.5%) with a mean age of 44,4 ±11.6 years (range 19-68). In the total group of patients, mean resting electromyographic values of the pelvic floor significantly improved from baseline to follow-up at 1 year (mean estimated difference 2.20 µV; 95% CI, 1.79 to 2.61; p<0.001). After 1 year, the fissure recurred in 15 patients (15.5%). VAS-pain significantly decreased from baseline to follow-up (mean estimated difference 4.16; 95% CI, 3.75 to 4.58; p<0.001). Dyssynergia was found in 72.9% at baseline and decreased to 14.4% at 1-year follow-up (p<0.001). Complaint reduction measured with the Proctoprom, significantly improved from baseline to 1-year follow-up (p<0.001). Quality of life (RAND-36) significantly improved in eight of nine domains at 1-year follow-up. No significant improvement was found in the domain vitality.Conclusions In the PAF-trial, we demonstrated that pelvic floor physical therapy yields a significant and clinical benefit in the time course and therefore should be advocated as adjuvant conservative treatment in patients with chronic anal fissure.