NCT07459790

The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions

Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome/Interstitial Cystitis (BPS/IC) With Hunner's Lesions

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: JSC NextGen · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis with Hunner's lesions to reduce cicatricial changes in the bladder caused by electrocoagulation and to prevent secondary bladder shrinkage with a decrease in its volume.

Conditions

• IC
• Hunner Type Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	Neovasculgen®	The bladder is hydro-bougienated, Hunner's lesions are identified, and electrocoagulation is performed using a resectoscope using standard techniques, followed by repeated hydro-bougienage of the bladder. The drug/placebo is then administered using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder. The drug/placebo is injected evenly along the edges of the coagulated area and into the Hunner's lesion itself, and then evenly along the bladder walls in a series of 30 injections.
DRUG	Placebo	The bladder is hydro-bougienated, Hunner's lesions are identified, and electrocoagulation is performed using a resectoscope using standard techniques, followed by repeated hydro-bougienage of the bladder. The drug/placebo is then administered using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder. The drug/placebo is injected evenly along the edges of the coagulated area and into the Hunner's lesion itself, and then evenly along the bladder walls in a series of 30 injections.

Timeline

• Start date: 2023-12-29
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Russia