Conditions: Interstitial Cystitis Painful Bladder Syndrome
Keywords: Bladder Pain GAG replacement therapy IC/PBS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: 20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period arm 2: 20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period

Interventions: intervention 1: 2% sodium chondroitin sulfate intervention 2: Placebo
Intervention descriptions: intervention 1: Weekly 20 mL Intravesical instillation intervention 2: The identical buffer used in Uracyst for the same administration

Protocol document: