OBJECTIVES: To evaluate the side effects, tolerability, and efficacy of transurethral microwave thermotherapy with urethral cooling (cooled TUMT) for chronic prostatitis/chronic pelvic pain syndrome in a prospective feasibility trial. Cooled TUMT, using the Targis system from Urologix, is an established treatment option for benign prostatic hyperplasia (BPH) with minimal side effects. METHODS:Patients with intractable chronic prostatitis/chronic pelvic pain syndrome and symptoms for more than 3 of the 6 months before treatment (National Institutes of Health-Chronic Prostatitis Symptom Index [NIH-CPSI] pain score of at least 8) were randomized to cooled TUMT at an intraprostatic temperature of either approximately 55 degrees C or approximately 70 degrees C. Tolerability, side effects, and efficacy were measured with standard diagnostic tests, including the NIH-CPSI. Subgroup analysis was performed to evaluate the effects with and without BPH comorbidity. RESULTS:A total of 42 patients were included in the study; 39 patients successfully completed treatment and 35 completed follow-up through 12 months. The baseline versus 12-month mean NIH-CPSI score was total score 23.4 +/- 6.4 versus 11.5 +/- 10.2 (improvement in mean value of 51%), pain score 11.5 +/- 2.8 versus 4.6 +/- 4.9 (improvement in mean value of 60%), quality-of-life impact score 7.2 +/- 2.9 versus 3.8 +/- 3.8 (improvement in mean value of 47%; all P <0.0001), and urinary score 4.7 +/- 2.8 versus 3.1 +/- 3.0 (improvement in mean value of 34%; P = 0.0079). Treatment discomfort was within the ranges reported for patients with Targis-treated BPH. Two patients had reduced sperm motility. Side effects were minimal and transient, resolved spontaneously or with medication, and were similar regardless of treatment temperature or BPH comorbidity. CONCLUSIONS:Cooled TUMT appears to be promising for intractable chronic prostatitis with or without BPH. Longer follow-up and a larger trial are required to evaluate the fertility impact and longer term durability further.
RCT Entities:
OBJECTIVES: To evaluate the side effects, tolerability, and efficacy of transurethral microwave thermotherapy with urethral cooling (cooled TUMT) for chronic prostatitis/chronic pelvic pain syndrome in a prospective feasibility trial. Cooled TUMT, using the Targis system from Urologix, is an established treatment option for benign prostatic hyperplasia (BPH) with minimal side effects. METHODS:Patients with intractable chronic prostatitis/chronic pelvic pain syndrome and symptoms for more than 3 of the 6 months before treatment (National Institutes of Health-Chronic Prostatitis Symptom Index [NIH-CPSI] pain score of at least 8) were randomized to cooled TUMT at an intraprostatic temperature of either approximately 55 degrees C or approximately 70 degrees C. Tolerability, side effects, and efficacy were measured with standard diagnostic tests, including the NIH-CPSI. Subgroup analysis was performed to evaluate the effects with and without BPH comorbidity. RESULTS: A total of 42 patients were included in the study; 39 patients successfully completed treatment and 35 completed follow-up through 12 months. The baseline versus 12-month mean NIH-CPSI score was total score 23.4 +/- 6.4 versus 11.5 +/- 10.2 (improvement in mean value of 51%), pain score 11.5 +/- 2.8 versus 4.6 +/- 4.9 (improvement in mean value of 60%), quality-of-life impact score 7.2 +/- 2.9 versus 3.8 +/- 3.8 (improvement in mean value of 47%; all P <0.0001), and urinary score 4.7 +/- 2.8 versus 3.1 +/- 3.0 (improvement in mean value of 34%; P = 0.0079). Treatment discomfort was within the ranges reported for patients with Targis-treated BPH. Two patients had reduced sperm motility. Side effects were minimal and transient, resolved spontaneously or with medication, and were similar regardless of treatment temperature or BPH comorbidity. CONCLUSIONS: Cooled TUMT appears to be promising for intractable chronic prostatitis with or without BPH. Longer follow-up and a larger trial are required to evaluate the fertility impact and longer term durability further.