INTRODUCTION: We report outcomes 1 year after surgery for the first 6 consecutive patients enrolled in an ongoing, prospective, Phase II clinical trial of laparoscopic radical prostatectomy (LRP) as a treatment for severely symptomatic, treatment-refractory chronic prostatitis. The protocol is approved by the Western Institutional Review Board and listed on the searchable National Institutes of Health clinical trials Web site. METHODS: Patients met prespecified eligibility criteria, were fully counseled before treatment, gave written informed consent, had surgery, and were regularly monitored after treatment. The primary outcome measure was symptom severity, which was measured prior to LRP and at 1, 3, 6, and 12 months after treatment using the Chronic Prostatitis Symptom Index (CPSI). The exact Wilcoxon signed rank test was used to compare pretreatment and 6-month posttreatment scores, with statistical significance at P <.05. Patients also described symptoms that were not included on the CPSI. Intraoperative and postoperative complications were recorded. RESULTS: Average patient age was 48.5 years (range, 31-61 years). The pretrial median disease duration was 6.5 years (range 3-31 years). Aside from their prostatitis, all patients were generally healthy. All patients had failed numerous medical, surgical, and complementary treatments. LRP was uncomplicated. All patients reported resolution of their prostatitis. Median CPSI scores were 35 before surgery and 26, 15.5, 10, and 7.5 at 1, 3, 6, and 12 months after surgery, respectively. The 6-month CPSI scores were significantly lower than the preoperative scores (P =.03). CONCLUSIONS: Preliminary data suggest that LRP may offer a previously unavailable level of relief for carefully selected patients with severely symptomatic, treatment-refractory chronic prostatitis. This potential needs to be further validated and more thoroughly characterized.
- Chronic prostatitis
- Clinical trial
- Laparoscopic radical prostatectomy
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