Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome: a multicenter, randomized, placebo controlled study.
OBJECTIVE
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.


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.
Nickel
J Curtis
JC
Department of Urology, Queens University, Kingston, Ontario, Canada. jcn@post.queensu.ca
Forrest
John B
JB
Tomera
Kevin
K
Hernandez-Graulau
Jose
J
Moon
Timothy D
TD
Schaeffer
Anthony J
AJ
Krieger
John N
JN
Zeitlin
Scott I
SI
Evans
Robert J
RJ
Lama
Daniel J
DJ
Neal
Durwood E
DE
Sant
Grannum R
GR
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010147:Pain Measurement; D017699:Pelvic Pain / Q000188:drug therapy*; D010426:Pentosan Sulfuric Polyester / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011472:Prostatitis / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D010426:Pentosan Sulfuric Polyester