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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals

Criteria

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