A multicenter, randomized, double-blind, parallel group pilot evaluation of the efficacy and safety of intravesical sodium chondroitin sulfate versus vehicle control in patients with interstitial cystitis/painful bladder syndrome.
OBJECTIVE
The goal of this pilot study was to gather information on differences between intravesical chondroitin sulfate and inactive vehicle control for treatment of interstitial cystitis/painful bladder syndrome (IC/PBS).


METHODS
This was a prospective, randomized, double-blind, inactive vehicle-controlled, 12-week study (6-week treatment period, followed by a 6-week follow-up period) in patients with IC/PBS. Patients were randomized to weekly intravesical treatment with 2.0% sodium chondroitin sulfate in phosphate-buffered saline or intravesical vehicle control. Primary efficacy analysis compared responders (moderately or markedly improved) according to the 7-point Global Response Assessment. Secondary endpoints include questionnaires focused on symptoms and quality of life.


RESULTS
Sixty-five evaluable patients were randomized. At the primary endpoint analysis (week 7), 22.6% of the vehicle control group were responders compared with 39.4% of the active therapy group (P = .15). There was no statistically significant difference for any of the secondary endpoints. Overall, 76.9% of the patients in the study reported at least 1 adverse event; most were mild or moderate, the majority associated with the vehicle control treatment. Nine nonserious intervention-related adverse events were reported in 3 patients in the vehicle control group compared with 2 in 1 patient in the active treatment group.


CONCLUSIONS
The difference in treatment effect in this small underpowered study was not statistically significant, although twice as many patients reported a clinically significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment. This trial provides data required to design a well-powered randomized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy.
Nickel
J Curtis
JC
Department of Urology, Queen's University, Kingston, Ontario, Canada. jcn@queensu.ca
Egerdie
R Blair
RB
Steinhoff
Gary
G
Palmer
Bruce
B
Hanno
Philip
P
D000283:Administration, Intravesical; D000328:Adult; D002809:Chondroitin Sulfates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D010865:Pilot Projects; D011446:Prospective Studies; D018401:Sample Size; D016896:Treatment Outcome
D002809:Chondroitin Sulfates