Efficacy of a Simplified Diagnostic-Therapeutic Strategy Based on the Prostate-Pelvic Syndrome Theory Versus NIH Conventional Classification‑Based Protocol for Type III Prostatitis: A Randomized Controlled Trial.

BACKGROUND: To evaluate and compare the efficacy of a simplified diagnostic and individualized comprehensive treatment strategy based on the "prostate-pelvic syndrome (PPS)" theory versus the traditional National Institutes of Health (NIH) conventional classification-based protocol for type III prostatitis in men under 40 years. METHODS: In this prospective randomized controlled trial, 222 patients (18-39 years) with type III prostatitis were randomly assigned to individualized comprehensive therapy guided by simplified PPS-based diagnosis (n = 112) or traditional NIH conventional classification-based therapy (n = 110) for 6 weeks. Randomization was performed using a computer-generated sequence with allocation concealment via sealed opaque envelopes. The primary endpoint was the change in the NIH-chronic prostatitis symptom Index (NIH-CPSI) total score and the response rate (≥ 6-point decrease). Secondary endpoints included changes in prostate volume (PV), NIH-CPSI subdomain scores, and the proportion of patients with sexual dysfunction (SD). Univariate and multivariate analyses identified factors influencing treatment response. RESULTS: A total of 212 patients completed follow-up (108 PPS and 104 NIH). Baseline characteristics were comparable between groups (p > 0.05). After treatment, the median decrease in NIH-CPSI total score was significantly greater in the PPS group than in the NIH group (p = 0.003), and the response rate was higher (79.6% versus 61.5%, p = 0.004). The intergroup difference was primarily driven by the quality-of-life domain (p = 0.003), while pain and voiding domain changes did not differ significantly between groups. Multivariate analysis identified PPS-based treatment [odds ratio (OR) = 2.227, 95% onfidence intervals (CI): 1.143-4.337] and baseline factors, including SD (OR = 0.334, 95% CI: 0.165-0.673), sedentariness (OR = 3.554, 95% CI: 1.652-7.642), and PV ≥ 20 mL (OR = 4.850, 95% CI: 1.870-12.575), as independent predictors of response. CONCLUSION: In men under 40 years with type III prostatitis, individualized comprehensive therapy guided by simplified PPS-based diagnosis was associated with greater symptom improvement-particularly in quality of life-compared with the traditional NIH conventional classification-based protocol. The findings suggest that a comprehensive, symptom-directed treatment strategy may outperform a more restricted classification-based regimen, though the contribution of the simplified diagnostic pathway-eliminating lower urinary tract pathogen localization and invasive expressed prostatic secretion testing-per se requires further study. TRIAL REGISTRATION: MR-34-24-035332; https://www.medicalresearch.org.cn.