Where am I: Product information > Efficacy > Study 2

Study 2 - Nickel et al 2009²

This phase II, multicentre, randomised, double-blind placebo-controlled study is the first positive placebo study to be presented on this class of therapy (intravesical GAG replenishment therapies).

The observed difference in treatment effect was not statistically significant. However, the results show that Uracyst is a promising treatment for PBS/IC and provides the impetus and data required to design a well-powered trial.

Sixty-five patients with a clinical diagnosis of IC were randomised to receive six once-weekly treatments of Uracyst or the intravesical placebo control.

Result

For the primary outcome at 7 weeks (after 6 weekly treatments), almost twice as many patients reported a clinically significant benefit with Uracyst compared to the control. Generally, both the Uracyst and placebo treatments were well tolerated by the subjects.

View graph

A responder was indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale.

∧ Back to top