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

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.

• 2% sodium chondroitin sulfate (Drug), also known as Uracyst: Weekly 20 mL Intravesical instillation
• Placebo (Drug), also known as buffer: The identical buffer used in Uracyst for the same administration

Primary outcomes

• Global Response Assessment (GRA) Responders at Week 11. [at week 11]: subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF

Secondary outcomes

• Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. [at week 11]: Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF

Sex: Female, ages: 18 Years to any

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

Participant flow

Outcome results

• Global Response Assessment (GRA) Responders at Week 11. (Primary), Number, participants: Uracyst 19; Placebo 15
• Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. (Secondary), Number, participants: Uracyst 23; Placebo 18

Adverse events

Serious adverse events by term

Other adverse events by term

• Lawrence A Hill, PharmD, MBA, Study director, Watson Laboratories, Inc.