OBJECTIVES: To investigate the effectiveness and durability of transurethral needle ablation (TUNA) in the treatment of symptoms of chronic pelvic pain syndrome (CPPS) in a randomized, single-blind, sham-controlled study. METHODS:Thirty-three patients with moderate-to-severe symptoms of CPPS were randomized to either TUNA (n = 25) or urethrocystoscopy as a sham treatment (n = 8). The response to therapy was evaluated 3, 6, and 12 months after treatment using the Prostatitis Symptom Severity Index (PSSI), the International Prostate Symptom Score (IPSS), a visual analogue scale, and prostate volume, prostate-specific antigen, urinary flow, and residual urine volume measurements. RESULTS: The PSSI decreased in both groups (TUNA group, P <0.001; sham group, P not significant), but no statistically significant difference was detected between them. Similarly, the IPSS decreased in the two groups (TUNA group, P = 0.002; sham group, P = 0.05), but no difference was found between those treated with TUNA and those who underwent sham treatment. Also the quality of life (IPSS-8) was significantly better at 12 months in both groups, but no difference was detected between them. Changes in pain score (visual analogue scale) were not statistically significant. Peak urinary flow rate, residual urine volume, prostate-specific antigen, and prostate volume were not altered in either group. CONCLUSIONS: The efficacy of TUNA in CPPS is comparable to sham treatment, and so cannot be recommended as routine treatment of CPPS.
RCT Entities:
OBJECTIVES: To investigate the effectiveness and durability of transurethral needle ablation (TUNA) in the treatment of symptoms of chronic pelvic pain syndrome (CPPS) in a randomized, single-blind, sham-controlled study. METHODS: Thirty-three patients with moderate-to-severe symptoms of CPPS were randomized to either TUNA (n = 25) or urethrocystoscopy as a sham treatment (n = 8). The response to therapy was evaluated 3, 6, and 12 months after treatment using the Prostatitis Symptom Severity Index (PSSI), the International Prostate Symptom Score (IPSS), a visual analogue scale, and prostate volume, prostate-specific antigen, urinary flow, and residual urine volume measurements. RESULTS: The PSSI decreased in both groups (TUNA group, P <0.001; sham group, P not significant), but no statistically significant difference was detected between them. Similarly, the IPSS decreased in the two groups (TUNA group, P = 0.002; sham group, P = 0.05), but no difference was found between those treated with TUNA and those who underwent sham treatment. Also the quality of life (IPSS-8) was significantly better at 12 months in both groups, but no difference was detected between them. Changes in pain score (visual analogue scale) were not statistically significant. Peak urinary flow rate, residual urine volume, prostate-specific antigen, and prostate volume were not altered in either group. CONCLUSIONS: The efficacy of TUNA in CPPS is comparable to sham treatment, and so cannot be recommended as routine treatment of CPPS.