Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF trial): quality of life outcome

Techniques in Coloproctology https://doi.org/10.1007/s10151-022-02741-7 ORIGINAL ARTICLE Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF trial): quality of life outcome D. A. van Reijn‑Baggen1,4 · H. W. Elzevier2 · J. P. B. M. Braak3 · H. Putter5 · R. C. M. Pelger4 · I. J. M. Han‑Geurts1 Received: 23 June 2022 / Accepted: 5 December 2022 © Springer Nature Switzerland AG 2022 Abstract Background Chronic anal fissure is one of the most common anorectal diseases and is associated with reduced quality of life. The aim of this study was to investigate the effects of pelvic floor physical therapy on quality of life in patients with chronic anal fissure using the Short-Form 36 Health Survey (RAND-36). Methods Adult patients, with chronic anal fissure and concomitant pelvic floor dysfunction, such as dyssynergia and increased pelvic floor muscle tone, were recruited at the Proctos Clinic in the Netherlands, between December 2018 and July 2021 and randomly assigned to an intervention group, receiving 8 weeks of pelvic floor physical therapy or assigned to a control group receiving postponed pelvic floor physical therapy (PAF trial). Quality of life and pain ratings were outcomes of the study and were measured at 8- and 20-week follow-up. Results One hundred patients (50 women and 50 men, median age 44.6 years [range 19–68 years]), completed the RAND36 questionnaire and visual analog (VAS) pain scale score at admission. A significant improvement was found at 20-week follow-up in all domains of the RAND-36; physical functioning, pain, health change (p < 0.001); physical role, vitality, general health, social functioning, emotional role, mental health (p < 0.05). VAS pain was significantly reduced at 8 weeks (mean estimated difference 1.98; 95% CI 1.55–2.42, p < 0.001) and remained significant at 20-week follow-up (p < 0.001). The difference between the groups as regards change in the mean pain intensity scores at 8 weeks was 2.48 (95% CI − 3.20 to − 1.75; p < 0.001). Compared to the reference values of the general Dutch population, the patients in our study with a chronic anal fissure and pelvic floor dysfunction reported an impaired quality of life in 8 of 9 domains of the RAND-36. After treatment, significant lower scores were found in 2 out of 9 domains. Conclusions The results of this study provide evidence that treatment by pelvic floor physical therapy improves quality of life and reduces pain, making it an important tool in management of chronic anal fissure and concomitant pelvic floor dysfunction. Keywords Chronic anal fissure · Quality of life · QoL · RAND-36 · SF-36 · Pelvic floor physical therapy Introduction * D. A. van Reijn‑Baggen 1 Department of Surgery, Proctos Clinics, Bilthoven, The Netherlands 2 Department of Urology and Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands 3 Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands 4 Department of Urology, Leiden University Medical Center, Leiden, The Netherlands 5 Department of Biomedical Data Science, Leiden University Medical Center, Leiden, The Netherlands Chronic anal fissure (CAF) is a common proctological problem associated with reduced quality of life [1]. CAF is defined as a longitudinal ulcer in the squamous epithelium [2] and gives rise to distressing symptoms of pain and bleeding during and after defecation. The incidence of CAF is nearly 0.11% (1.1 cases per 1000 persons) and varies considerably according to age and sex [3]. Persistence of symptoms for long periods may lead to functional and psychosocial impairment [4], and seeking medical care is often delayed due to embarrassment [5]. Furthermore, in patients with CAF, there is a high degree of depression, anxiety and stress [1]. 13 Vol.:(0123456789) Techniques in Coloproctology Health-related quality of life (QoL) can be influenced by physical, psychological and social factors, an individual’s life experience and general well-being [1, 6]. The purpose of health-related QoL evaluations is to move beyond clinical symptoms by examining how patients perceive and experience the impact on well-being and daily life [6, 7]. The most common generic instrument to measure QoL is the validated Medical Outcomes 36-Item Short-Form Health Survey (SF-36) used for decision-making for health care policies and clinical interventions [8]. Although there is a need to integrate aspects of functional and psychosocial impairment into medical care [9], only a few studies report on QoL in patients with CAF. Recently, the Pelvic floor Anal Fissure study (PAF trial) was completed, which is a randomized controlled trial demonstrating the beneficial effects of pelvic floor physical therapy (PFPT) on an improvement of pelvic floor muscle tone and function, VAS pain scores, fissure healing and complaint reduction [10]. The aim of PFPT is to increase awareness and proprioception, to improve muscle relaxation, elasticity and function of the pelvic floor muscles, to restore abdominopelvic coordination, rectal sensitivity and reduce pain [11, 12]. In the PAF trial, we also hypothesized that treatment of PFPT will improve QoL. Here, we present the results of QoL measured with the Short-Form RAND-36 (RAND-36) [13] and visual analog scale (VAS) pain ratings in patients with CAF and pelvic floor dysfunction, who were included in the PAF trial. Furthermore, to better elucidate the results, the study compares baseline and post-treatment values with reference values of the RAND-36 of the general Dutch population [13]. Materials and methods Study design Quality of life was assessed with the RAND-36 in the PAF trial [14]. The PAF trial is a single-center, parallel, randomized controlled trial. The design involved allocation of all appropriate consecutive patients older than 18 years with CAF and pelvic floor dysfunction. Eligible patients were randomly assigned, after providing written informed consent to an intervention group receiving 8 weeks of PFPT or assigned to postponed PFPT (1:1 allocation). Participants Men and women aged 18 years or older presenting CAF and pelvic floor dysfunction were recruited by the surgeon at the Proctos Clinic in the Netherlands. CAF was defined 13 as a longitudinal ulcer in the squamous epithelium with one or more signs of chronicity including hypertrophied anal papilla, sentinel tag and exposed internal sphincter muscle. Patients had fissure complaints of more than 6 weeks, and all patients failed in conservative treatment with fibers and/or laxatives and had applied the ointment (diltiazem or isosorbide di-nitrate) internally for at least 6 weeks. Pelvic floor dysfunction was defined by the presence of dyssynergia and/or increased pelvic floor muscle tone. All patients had sufficient understanding of the Dutch language (reading and writing) and were able to complete the online questionnaires. Patients who were not able to undergo a digital rectal (...truncated)