Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome

A multicenter, randomized, placebo controlled study

J. Curtis Nickel, John B. Forrest, Kevin Tomera, Jose Hernandez-Graulau, Timothy D. Moon, Anthony J. Schaeffer, John N. Krieger, Scott I. Zeitlin, Robert J. Evans, Daniel J. Lama, Durwood Earnest Neal, Grannum R. Sant

Research output: Contribution to journalArticle

74 Citations (Scopus)

Abstract

Purpose: We evaluated the efficacy and tolerability of pentosan polysulfate sodium (PPS) for the treatment of men with chronic pelvic pain syndrome (CPPS), National Institutes of Health (NIH) category III. Materials and Methods: In a 16-week double-blind study 100 men with a clinical diagnosis of CPPS were randomized to receive 300 mg PPS or placebo 3 times daily. Clinical Global Improvement (CGI) was the primary outcome measure. Additional outcome measures were the NIH-Chronic Prostatitis Symptom Index (CPSI), Subjective Global Assessment and Symptom Severity Index assessment tools. Results: Significantly more patients receiving PPS experienced moderate to marked improvement based on CGI assessment (18 or 37% vs 8 or 18%, p = 0.04). However, mean CGI scores were not significantly different between the PPS group (1.0) and placebo groups (1.0 vs 0.6, p = 0.107). All NIH-CPSI domains suggested a positive effect for PPS and for total NIH-CPSI the difference approached statistical significance (-5.9 or 22% vs -3.2 or 12%, p = 0.068). The PPS group showed significantly greater improvement in NIH-CPSI quality of life domain scores than the placebo group (-2.0 or 22% vs -1.0 or 12%, p = 0.031). Of patients receiving PPS 67% and 80% of those receiving placebo completed the 16-week study. Diarrhea, nausea and headache were the most common adverse events. Conclusions: Pentosan polysulfate (900 mg daily) was more likely than placebo to provide relief for CPPS symptoms.

Original languageEnglish (US)
Pages (from-to)1252-1255
Number of pages4
JournalJournal of Urology
Volume173
Issue number4
DOIs
StatePublished - Jan 1 2005
Externally publishedYes

Fingerprint

Pentosan Sulfuric Polyester
Pelvic Pain
Chronic Pain
Placebos
National Institutes of Health (U.S.)
Prostatitis
Therapeutics
Outcome Assessment (Health Care)
Symptom Assessment
Double-Blind Method
Nausea
Headache
Diarrhea
Quality of Life

Keywords

  • Pelvic pain
  • Pentosan sulfuric polyester
  • Prostate
  • Prostatitis

ASJC Scopus subject areas

  • Urology

Cite this

Nickel, J. C., Forrest, J. B., Tomera, K., Hernandez-Graulau, J., Moon, T. D., Schaeffer, A. J., ... Sant, G. R. (2005). Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome: A multicenter, randomized, placebo controlled study. Journal of Urology, 173(4), 1252-1255. https://doi.org/10.1097/01.ju.0000159198.83103.01

Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome : A multicenter, randomized, placebo controlled study. / Nickel, J. Curtis; Forrest, John B.; Tomera, Kevin; Hernandez-Graulau, Jose; Moon, Timothy D.; Schaeffer, Anthony J.; Krieger, John N.; Zeitlin, Scott I.; Evans, Robert J.; Lama, Daniel J.; Neal, Durwood Earnest; Sant, Grannum R.

In: Journal of Urology, Vol. 173, No. 4, 01.01.2005, p. 1252-1255.

Research output: Contribution to journalArticle

Nickel, JC, Forrest, JB, Tomera, K, Hernandez-Graulau, J, Moon, TD, Schaeffer, AJ, Krieger, JN, Zeitlin, SI, Evans, RJ, Lama, DJ, Neal, DE & Sant, GR 2005, 'Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome: A multicenter, randomized, placebo controlled study', Journal of Urology, vol. 173, no. 4, pp. 1252-1255. https://doi.org/10.1097/01.ju.0000159198.83103.01
Nickel, J. Curtis ; Forrest, John B. ; Tomera, Kevin ; Hernandez-Graulau, Jose ; Moon, Timothy D. ; Schaeffer, Anthony J. ; Krieger, John N. ; Zeitlin, Scott I. ; Evans, Robert J. ; Lama, Daniel J. ; Neal, Durwood Earnest ; Sant, Grannum R. / Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome : A multicenter, randomized, placebo controlled study. In: Journal of Urology. 2005 ; Vol. 173, No. 4. pp. 1252-1255.
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abstract = "Purpose: We evaluated the efficacy and tolerability of pentosan polysulfate sodium (PPS) for the treatment of men with chronic pelvic pain syndrome (CPPS), National Institutes of Health (NIH) category III. Materials and Methods: In a 16-week double-blind study 100 men with a clinical diagnosis of CPPS were randomized to receive 300 mg PPS or placebo 3 times daily. Clinical Global Improvement (CGI) was the primary outcome measure. Additional outcome measures were the NIH-Chronic Prostatitis Symptom Index (CPSI), Subjective Global Assessment and Symptom Severity Index assessment tools. Results: Significantly more patients receiving PPS experienced moderate to marked improvement based on CGI assessment (18 or 37{\%} vs 8 or 18{\%}, p = 0.04). However, mean CGI scores were not significantly different between the PPS group (1.0) and placebo groups (1.0 vs 0.6, p = 0.107). All NIH-CPSI domains suggested a positive effect for PPS and for total NIH-CPSI the difference approached statistical significance (-5.9 or 22{\%} vs -3.2 or 12{\%}, p = 0.068). The PPS group showed significantly greater improvement in NIH-CPSI quality of life domain scores than the placebo group (-2.0 or 22{\%} vs -1.0 or 12{\%}, p = 0.031). Of patients receiving PPS 67{\%} and 80{\%} of those receiving placebo completed the 16-week study. Diarrhea, nausea and headache were the most common adverse events. Conclusions: Pentosan polysulfate (900 mg daily) was more likely than placebo to provide relief for CPPS symptoms.",
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AU - Moon, Timothy D.

AU - Schaeffer, Anthony J.

AU - Krieger, John N.

AU - Zeitlin, Scott I.

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