title: Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis.
abstract: OBJECTIVE
  To compare the current recommended dose of pentosan polysulfate sodium (PPS) with doses two to three times higher.
  
  
  METHODS
  We evaluated three dosages (300, 600, and 900 mg) of PPS in a randomized, double-blind, double-dummy, parallel-group, multicenter, 32-week study. Adults (n = 380) with a diagnosis of interstitial cystitis (IC) as determined by a positive cystoscopic examination combined with bladder pain and urgency or a history of IC symptoms for at least 6 months were enrolled. Participants completed the Patient's Overall Rating of Symptom Index (PORIS) and the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) at baseline (ICSI only) and during follow-up visits at 4, 8, 12, 16, 24, and 32 weeks.
  
  
  RESULTS
  Mean ICSI scores improved significantly during the 32 weeks for all dosages (baseline 11.2, 11.9, and 11.9 to endpoint 8.2, 8.1, 8.6 for 300, 600, and 900 mg, respectively; P <0.001) but the response to treatment was not dose dependent (no statistically significant difference in response among the three dosages). At baseline, 3.2%, 62.2%, and 34.6% reported mild, moderate, and severe symptoms, respectively, as assessed by the ICSI. At study end, 27.5%, 56.9%, and 15.7% reported mild, moderate, and severe symptoms, respectively. The PORIS scores improved within 4 weeks with 15.8% to 21.1% of all patients classified as responders (50% or greater improvement on PORIS). At 32 weeks, 49.6%, 49.6%, and 45.2% of all patients were responders at a dose of 300, 600, and 900 mg, respectively. Most adverse events were mild and resolved without intervention.
  
  
  CONCLUSIONS
  For all three dosages of PPS, a clinically significant but similar response was demonstrated. The duration of therapy appears to be more important than the dosage.
authors.affiliation: Department of Urology, Queens University, Kingston General Hospital, Kingston, Ontario, Canada. jcn@post.queensu.ca
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Jack
authors.initials: J
authors.lastname: Barkin
authors.forename: John
authors.initials: J
authors.lastname: Forrest
authors.forename: Phillip G
authors.initials: PG
authors.lastname: Mosbaugh
authors.forename: J
authors.initials: J
authors.lastname: Hernandez-Graulau
authors.forename: David
authors.initials: D
authors.lastname: Kaufman
authors.forename: Keith
authors.initials: K
authors.lastname: Lloyd
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Evans
authors.forename: C Lowell
authors.initials: CL
authors.lastname: Parsons
authors.forename: Linda E
authors.initials: LE
authors.lastname: Atkinson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010426:Pentosan Sulfuric Polyester / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010426:Pentosan Sulfuric Polyester