Phase 2b Study of VNX001 for Treating Moderate to Severe Acute Bladder Pain in Adults with Interstitial CystitisBladder Pain Syndrome Over 14 Days

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and dosing frequency of VNX001 in people with Interstitial CystitisBladder Pain Syndrome ICBPS, a condition causing moderate to severe bladder pain. This Phase 2b, open-label study focuses on treating acute episodes of bladder pain and aims to count the number of doses used and measure pain levels before and after treatment. The research also monitors how well participants tolerate VNX001 and any side effects. Participants will receive up to six doses of VNX001 administered directly into the bladder through a catheter over a 14-day period. Each dose contains 15 mL of buffered lidocaine HCl and sodium heparin. The study includes up to seven clinic visits, which cover screening and dosing appointments, or at least one combined screening and dosing visit plus five telephone calls. The dosing is given as needed based on pain episodes. During the study, participants will record their bladder pain, urinary urgency, side effects, and any medications taken daily via a diary or telephone calls. Researchers will assess pain changes at multiple time points after dosing and track overall symptom improvement. Safety is monitored through adverse event reporting up to 17 days. The study lasts 14 days, during which participants will have frequent contact with the clinic for evaluations and support.

Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)