Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Inclusion Criteria:

• Are a female, 18 years or older
• Have been diagnosed with IC/PBS
• Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation

Exclusion Criteria:

• Are lactating females
• Have previously received investigational products or devices within 30 days of screening
• Have previously received Uracyst
• Are currently receiving therapy with Interstim®
• Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
• Are unable or unwilling to comply with protocol requirements