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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Interstitial Cystitis, Painful Bladder Syndrome

Intervention / Treatment
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* Drug: 2% sodium chondroitin sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8 weekly bladder instillations of Uracyst<br>20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period | Drug: 2% sodium chondroitin sulfate<br>* Weekly 20 mL Intravesical instillation<br>* Other names: Uracyst;|
| Placebo Comparator: 8 weekly bladder instillations of inactive control<br>20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period | Drug: Placebo<br>* The identical buffer used in Uracyst for the same administration<br>* Other names: buffer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Response Assessment (GRA) Responders at Week 11. | subjects that indicated markedly improved or moderately improved on the GRA, LOCF | at week 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. | Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF | at week 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder Pain, GAG replacement therapy, IC/PBS