Abstract Background Chronic non-bacterial prostatitis (CNBP) is a common disease associated with pain, urinary and sexual symptoms. Diagnosis and treatment of CNBP is usually difficult and requires multiple approaches and usually with unsatisfactory outcomes. Aim and Objectives to assess the effectiveness of the intraprostatic Botulinum toxin type A (BONT-A) in the treatment of refractory CNBP in a randomized sham-controlled trial. Subject and Methods 70 patients with refractory CNBP were equally randomized into two groups. Patients in treatment group (group 1) received transurethral intraprostatic BONT-A injection, whereas patients in sham group (group 2) received transurethral intraprostatic saline injection. Baseline national institute of health chronic prostatitis symptom index (NIHCPSI) was evaluated before intervention and reassessed after 1, 3 and 6 months following treatment. Result Age, prostate size, duration of symptoms as well as baseline total NIHCPSI were not statistically significantly different between both groups before intervention (30.29 vs. 29.8 for group 1 vs. group 2 respectively, p = 0.583). We found statistically significantly reduction of NIHCPSI total score in group 1 compared to group 2 at all intervals of follow up (27.21 vs. 29.03, p = 0.037, 24.97 vs. 28.59, p < 0.001 and 21.76 vs. 27.27, p < 0.001, at 1, 3 and 6 months respectively). Mean pain subscale scores statistically significantly decreased in group 1 compared to group 2 from baseline (14.77 and 14.06 for group 1 and group 2 respectively, p = 0.127) to 12.52 and 13.79, p = 0.010, 11.53 and. 13.25 p < 0.001 and 10 and 13.33, p < 0.001 after 1, 3 and 6 months respectively. Similarly, mean quality of life score statistically significantly improved in group 1 compared to group 2 from baseline (7.74 and. 8.40 for group 1 and. group 2 respectively, p = 0.038), then after 1, 3 and 6 months (6.09 vs. 7.88, p < 0.001, 5.56 vs. 7.81, p < 0.001 and 4.74 vs. 7.39, p < 0.001 respectively). Mean urinary symptoms scores statistically significantly decreased in group 1 compared to group 2 at all follow up intervals from baseline (7.77 and. 7.34 for group 1 and group 2 respectively, p = 0.136), to 6.15 vs. 7.06, p < 0.001, 5.75 vs. 6.97, p < 0.001, 4.91 vs. 6.58 p < 0.001 after 1, 3 and 6 months respectively. Maximal effect of treatment with BONT-A was at 6 months. Mild dysuria and hematuria were the only two postoperative complications encountered after intervention in both groups. Conclusion Transurethral intraprostatic injection of BONT-A is a safe and effective treatment for refractory CNBP.
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