Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Phase 2

Terminated

• Conditions: Painful Bladder Syndrome; Interstitial Cystitis; Bladder Pain Syndrome

• Registration Number: NCT00517868
• Lead Sponsor: Urigen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-8-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - male and female subjects >= 18 years of age<br><br> - moderate to severe symptoms of PBS/IC<br><br> - minimum pain/urgency/frequency scores<br><br> - female subjects on hormone therapy must be on stable dose for >= 3 months<br><br>Exclusion Criteria:<br><br> - positive pregnancy test or pregnant or lactating<br><br> - narcotics or medical marijuana within 3 months<br><br> - use of any investigational drug or device within 30 days<br><br> - bacterial cystitis within 30 days

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Daytime Bladder Pain Intensity

Secondary Outcome Measures

Name	Time	Method
Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire;Change in Total Symptom Score;Change in Daytime Urinary Urgency Score