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

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. Ninety-seven 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. TRIAL REGISTRATION: The trial is registered at the Dutch Trial registry (NTR7581)  https://trialsearch.who.int.

Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial.

BACKGROUND: A chronic anal fissure is a common, painful condition with great impact on daily life. The exact pathogenesis has not been fully elucidated and treatment varies. A large percentage of patients experience pelvic floor dysfunction (dyssynergia and increased pelvic floor muscle tone). The aim of our study was to investigate the effect of pelvic floor physical therapy in patients with chronic anal fissure. METHODS: 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 pelvic floor physical therapy including electromyographic biofeedback or assigned to a control group receiving postponed pelvic floor physical therapy. The primary outcome was muscle tone at rest during electromyographic registration of the pelvic floor before and after pelvic floor physical therapy. Secondary outcomes contained healing of the fissure, pain ratings, improvement of pelvic floor function, and complaint reduction measured with a proctology-specific patient-reported outcome measurement. Endpoints were measured at 8- and 20-week follow-up. RESULTS: One hundred forty 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. CONCLUSIONS: The findings of this study provide strong evidence that pelvic floor physical therapy is effective in patients with chronic anal fissure and pelvic floor dysfunction and supports its recommendation as adjuvant treatment besides regular conservative treatment.

Management of chronic anal fissure: results of a national survey among gastrointestinal surgeons in the Netherlands.

BACKGROUND: Chronic anal fissure (CAF) is a common, bothersome condition frequently accompanied by pelvic floor complaints. Despite current guidelines, optimal management is challenging. The aim of this study is to evaluate current management of CAF among gastrointestinal surgeons in the Netherlands. METHODS: Dutch gastrointestinal surgeons and residents were sent a survey invitation by email, which was available online between June 2021 and September 2021. The questionnaire consisted of 21 questions concerning work experience, physical examination, diagnostic and surgical techniques, and follow-up. RESULTS: Overall, 106 (33%) respondents completed the survey. Most respondents (59%) had at least 10 years of experience in treating CAF. Only 23% always addressed pelvic floor complaints. Fifty-one percent performed digital rectal examination and 22% always, or almost always, examined the pelvic floor muscles. Most respondents started treatment with fibers and/or laxatives and ointment (96%). Diltiazem was in 90% the preferred ointment. Twenty-two percent referred patients for pelvic floor physical therapy. Botulinum toxin was in 54% performed under general or spinal anesthesia or sedation. The surgical procedure of choice was fissurectomy (71%) followed by lateral internal sphincterotomy (27%). Fissurectomy was in 51% always combined with botulinum toxin. Fifty-seven percent of the respondents preferred a physical follow-up appointment. CONCLUSION: Guideline recommendations are largely followed in the Netherlands, starting with conservative measures followed by surgical procedures. Surgeons do not consistently assess pelvic floor complaints, nor do they routinely examine the pelvic floor muscles. Awareness of pelvic floor dysfunctions is important to refer patients for pelvic floor physical therapy.

Pelvic Floor Physical Therapy for Pelvic Floor Hypertonicity: A Systematic Review of Treatment Efficacy.

INTRODUCTION: Hypertonicity of the pelvic floor (PFH) is a disabling condition with urological, gynecological and gastrointestinal symptoms, sexual problems and chronic pelvic pain, impacting quality of life. Pelvic floor physical therapy (PFPT) is a first-line intervention, yet no systematic review on the efficacy of PFPT for the treatment of PFH has been conducted. OBJECTIVES: To systematically appraise the current literature on efficacy of PFPT modalities related to PFH. METHODS: PubMed, Embase, Emcare, Web of Science, and Cochrane databases were searched from inception until February 2020. A manual search from reference lists of included articles was performed. Ongoing trials were reviewed using clinicaltrial.gov. Randomized controlled trials (RCTs), prospective - and retrospective cohorts and case-study analyses were included. Outcome measures were pelvic floor muscle tone and function, pain reports, sexual function, pelvic floor symptom scores, quality of life and patients' perceived effect. RESULTS: The literature search resulted in 10 eligible studies including 4 RCTs, 5 prospective studies, and 1 case study published between 2000 and 2019. Most studies had a high risk of bias associated with the lack of a comparison group, insufficient sample sizes and non-standardized interventions. Six studies were of low and 4 of medium quality. All studies were narratively reviewed. Three of 4 RCTs found positive effects of PFPT compared to controls on five out of 6 outcome measures. The prospective studies found significant improvements in all outcome measures that were assessed. PFPT seems to be efficacious in patients with chronic prostatitis, chronic pelvic pain syndrome, vulvodynia, and dyspareunia. Smallest effects were seen in patients with interstitial cystitis and painful bladder syndrome. CONCLUSION: The findings of this systematic review suggest that PFPT can be beneficial in patients with PFH. Further high-quality RCTs should be performed to confirm the effectiveness of PFPT in the treatment of PFH. van Reijn-Baggen DA, Han-Geurts IJM, Voorham-van der Zalm PJ, et al. Pelvic Floor Physical Therapy for Pelvic Floor Hypertonicity: A Systematic Review of Treatment Efficacy. Sex Med Rev 2022;10:209-230.

Pelvic floor physical therapy in the treatment of chronic anal fissure (PAF-study): Study protocol for a randomized controlled trial.

BACKGROUND: Chronic anal fissure (CAF) is a common cause of severe anorectal pain with a high incidence rate. Currently, a wide range of treatment options are available with recurrence rates varying between 7 and 42%. Pelvic floor physical therapy (PFPT) is a treatment option for increased pelvic floor muscle tone and dyssynergia which often accompanies CAF. However, literature on this subject is scarce. The Pelvic Floor Anal Fissure (PAF)-study aims to determine the efficacy and effectiveness of PFPT on improvement on pelvic floor muscle tone and function, pain, healing of the fissure, quality of life and complaint reduction in patients with CAF. METHODS: The PAF-study is a single-centre, two armed, randomized controlled trial. Patients with CAF and pelvic floor dysfunction are eligible for inclusion. Exclusion criteria include abscess, fistula, Crohn's disease, ulcerative colitis, anorectal malignancy, prior rectal radiation, and pregnancy. A total of 140 patients will be 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 weeks and at 1-year follow-up. DISCUSSION: Currently, there is a gap in treatment modalities between conservative management and surgery. This manuscript prescribes the rationale, design, and methodology of a randomized controlled trial investigating PFPT as a treatment option for patients with CAF.