title: A real-life multicentre clinical practice study to evaluate the efficacy and safety of intravesical chondroitin sulphate for the treatment of interstitial cystitis.
abstract: OBJECTIVE
  To report a multicentre, community based open-label study designed to assess the efficacy and safety of intravesical sodium chondroitin sulphate in the treatment of patients with the clinical diagnosis of interstitial cystitis (IC). Chondroitin sulphate is a naturally occurring glycosaminoglycan (GAG) in the bladder mucus layer and changes in this GAG have been implicated in the pathogenesis of IC, and small single-centre studies have suggested that intravesical chondroitin sulphate may have efficacy in IC.
  
  
  METHODS
  Patients with IC were treated with sodium chondroitin sulphate (Uracyst, Stellar Pharmaceuticals Inc., London ON, Canada) solution 2.0% via urinary catheter weekly for 6 weeks and then monthly for 16 weeks for a total of 10 treatments. The primary efficacy endpoint was the percentage of responders to treatment as indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale at week 10 (4 weeks after the initial six treatments) compared with baseline. A major secondary efficacy endpoint (durability) was the percentage of responders on the GRA scale after 10 treatments. Additional secondary efficacy objectives were differences from baseline in Patient Symptom/Problem Index scores over the course of the treatment compared with baseline.
  
  
  RESULTS
  In all, 47% of the 53 enrolled patients with long standing moderately severe IC (mean [SD, range] diagnosis of IC 3.0 [3.4, 0.1-16] years; duration of symptoms 9.2 [9.2, 1-39] years; baseline symptom score 14.2 [3.2]) were responders at week 10. At 24 weeks, 60% were responders. There was a statistically and clinically significant decrease in the mean (SD) symptom and bother scores from baseline at 10 weeks and 24 weeks, at 9.0 (4.3) and 8.1 (5.0), respectively (P < 0.001). There were no significant safety issues during the study.
  
  
  CONCLUSIONS
  This multicentre community based real-life clinical practice study suggests that intravesical chondroitin sulphate may have an important role in the treatment of IC and validates the rationale for a randomized placebo-controlled trial.
authors.affiliation: Department of Urology, Centre for Applied Urological Research, Queen's University, Kingston, ON, Canada. jcn@queensu.ca
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: Blair
authors.initials: B
authors.lastname: Egerdie
authors.forename: Joe
authors.initials: J
authors.lastname: Downey
authors.forename: Rajiva
authors.initials: R
authors.lastname: Singh
authors.forename: Anthony
authors.initials: A
authors.lastname: Skehan
authors.forename: Leslie
authors.initials: L
authors.lastname: Carr
authors.forename: Karen
authors.initials: K
authors.lastname: Irvine-Bird
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002809:Chondroitin Sulfates / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D018856:Cystitis, Interstitial / Q000188:drug therapy; D005260:Female; D006025:Glycosaminoglycans / Q000378:metabolism; D006801:Humans; D008875:Middle Aged; D011188:Potassium / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D006025:Glycosaminoglycans; D002809:Chondroitin Sulfates; D011188:Potassium