Laparoscopic prostatectomy for severely symptomatic, treatment-refractory chronic prostatitis: Preliminary observations from an ongoing phase II clinical trial

Abstract

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