Pentosan polysulfate therapy for chronic nonbacterial prostatitis (chronicpelvic pain syndrome category IIIA): A prospective multicenter clinical trial

Objectives. Chronic nonbacterial prostatitis/chronic pelvic pain syndrome ( CPPS) has clinical and perhaps etiologic characteristics similar to interst itial cystitis. Pentosan polysulfate sodium (PPS), an oral medication indic ated for the treatment of interstitial cystitis, has shown moderate benefit in reducing chronic pelvic pain and voiding symptoms in patients with inte rstitial cystitis. We undertook a prospective open-label, multicenter Phase II pilot study to examine the potential efficacy of PPS in the treatment o f CPPS in men, using outcome tools validated for CPPS in men. Methods. Patients with a diagnosis consistent with National institutes of H ealth (NIH) CPPS category IIIA (inflammatory) were treated with PPS, 100 mg three times daily, for 6 months. The evaluation at baseline, 3 months, and 6 months consisted of the Symptom Severity Index, a Symptom Frequency Ques tionnaire, the NIH-Chronic Prostatitis Symptom Pain Index (NIH-CPSI), a qua lity-of-life assessment, and a subjective global assessment. Results. Thirty-two patients (mean age 45.5 +/- 11 years; duration of sympt oms 9.2 +/- 12 years) were enrolled in five centers; 28 patients were avail able for evaluation. Seven patients experienced drug-related side effects, including hair loss (n = 2), headache (n = 2), mild nausea (n = 1), mild we ight gain (n = 1), and skin flushing (n = 1). The decrease in frequency (Sy mptom Frequency Questionnaire 28. 1 to 17.9), severity (Symptom Severity In dex 53.6 to 36.3), and combined location/frequency/severity of pain (NIH-CP SI pain 14.5 to 9.2) symptom scores at 6 months compared with baseline was significant. The decrease was associated with a significant improvement in patients' quality of life (quality-of-life assessment 5.3 to 3.8). Forty-th ree percent of the patients had a greater than 50% improvement in the Sympt om Frequency Questionnaire, Symptom Severity Index, and NIH-CPSI (rated as clinically significant improvement). At 6 months, mild, moderate, and marke d improvement was noted (subjective global assessment) by 33%, 19%, and 15% of the patients, respectively. Conclusions. PPS is well tolerated and appears to have efficacy in reducing the severity and frequency of general symptoms, reducing specific pain sym ptoms, and improving the quality of life in many male patients with CPPS. T he results of this study justify the initiation of a randomized controlled trial comparing the safety and efficacy of PPS to placebo. UROLOGY 56: 413- 417, 2000. (C) 2000, Elsevier Science Inc.