Hypothesis / aims of study
Chronic Pelvic Pain Syndrome (CPPS) is a chronic or persistent pain perceived in structures related to the pelvis of men. It is often associated with negative cognitive, behavioral, sexual and emotional consequences as well as with symptoms suggestive of LUTS, sexual, bowel, pelvic floor or gynecological dysfunction. It is continuous or recurrent for at least six months. The pathophysiology is complex involving Central Nervous System (CNS), Peripheral Nervous System (PNS), musculoskeletal system, and emotional component. The exact cause of pain still is unknown. As the cause is not well defined, treatment also has variable options. The exact treatment is not yet defined. There have been studies telling about the benefits of alpha blocker, SSRI, pregabalin, botulinum toxin and physiotherapy. With our previous experience in Chronic Pelvic Pain Syndrome patients, alpha blocker (Alfuzosin) with selective serotonin reuptake inhibitor(SSRI) (amitriptyline) works well for symptomatic relief after ruling out infection and giving 4-6 weeks of antibiotics. There have been studies which suggests physiotherapy only or physiotherapy with psychotherapy gives good symptomatic relief in Chronic Pelvic Pain Syndrome. Yoga also works on the similar basis of physiotherapy, although we could not find any comparative study for the same. We here aim to compare the efficacy of Alfuzosin and Amitriptyline with yoga and placebo in males with Chronic Pelvic Pain Syndrome.
Study design, materials and methods
It was a randomized crossover study (CTRI/2022/05/042706) with 20 patients in each group. Group 1 received Alfuzosin and Amitriptyline and group 2 received Yoga with placebo for six weeks. After the end of six weeks, a washout period of one week was given and the crossover was done. NIH -CPSI score was calculated at initiation of therapy, after 6 weeks and at 12 weeks. The NIH-CPSI has a total score range from 0 to 43, and it includes three subscales addressing pain (score range 0–21), urinary symptoms (score range 0–10), and quality of life (QOL) (score range 0–12). The pain subscale consists of six items which are each scored from 0 to 1, one item which is scored from 0 to 5, and one item which is scored from 0 to 10. The urinary subscale consists of two items, each of which is scored from 0 to 3. The QOL subscale includes two items that are scored from 0 to 3, and one item that is scored from 0 to 6. The change in NIH-CPSI scores was noted and compared using SPSS and R software.
Interpretation of results
This randomised cross over trial showed that both treatment regimens (Alfuzosin and Amitriptyline vs. Yoga with placebo) led to significant improvements in NIH-CPSI scores, indicating a reduction in pain and urinary symptoms and an improvement in quality of life (QoL). Specifically, Alfuzosin and Amitriptyline resulted in a median decrease of 10 points in overall NIH-CPSI score, while Yoga with placebo resulted in a median decrease of 9 points. These differences were statistically significant.