COPE Trial: comparison of yoga therapy versus medical therapy in men with chronic pelvic pain syndrome-a pilot randomised crossover trial.

PURPOSE: Chronic pelvic pain syndrome (CPPS) is a complex and prevalent condition in men, but with few long-term treatment options. Yoga can reduce pain and pelvic floor dysfunction, but there is no evidence comparing yoga with medical management in men. Effects of yoga Therapy (YT) with medical therapy (MT) in men with CPPS are compared in this study.

METHODS

We performed a prospective randomised crossover study at a tertiary referral centre. We randomised 40 men aged ≥18 years with CPPS (as per European Association of Urology criteria) to either MT followed by YT or YT followed by MT with a 1 week washout period in between. In MT, alfuzosin 10 mg daily and titrated amitriptyline 10-50 mg daily was given for 6 weeks. YT comprised of supervised structured 1 h daily yoga for 6 weeks. Primary outcome was recorded as the change in total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score. The secondary outcomes consisted of pain, urinary, and quality-of-life subdomain scores. This trial has been registered on Clinical Trials Registry of India (CTRI/2022/05/042706).

RESULTS

All patients who were randomised completed both phases of treatment. There was a mean improvement in NIH-CPSI total score of -10.8 points with MT and -8.4 with YT. This resulted in a difference of -2.4 points (95% confidence interval between both groups (95% confidence interval [CI] -4.9 to 0.1), showing that YT was non inferior. Pain and quality-of-life scores were almost similar between both the groups. MT was more effective in improving urinary symptoms (difference -1.2 points, 95% CI -1.8 to -0.6; p < 0.001). However, more adverse events were reported with MT than YT (27.5% vs 10.0%; p = 0.04). There was no significant carryover effect. The study has limitations like being single-centred, small sample size and inability to completely blind the yoga intervention.

CONCLUSIONS

YT was not inferior to alfuzosin plus amitriptyline (MT) for improving symptoms in men with CPPS and had fewer side effects. Yoga could be used as an add-on or maintenance therapy while MT could be more preferable in men with predominant urinary symptoms.