Neovasculgen for 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

This study will test whether Neovasculgen can reduce bladder scarring and prevent bladder shrinkage in women with interstitial cystitis and Hunner's lesions.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: JSC NextGen (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Moscow)
• Trial ID: NCT07459790 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2/3 study compares Neovasculgen with placebo in women aged 18–65 who have interstitial cystitis with confirmed Hunner's lesions and symptoms for at least 12 months. Participants receive Neovasculgen or placebo in addition to standard lesion management and are followed for safety, bladder scarring, bladder volume, and symptoms. Outcomes are measured with cystoscopy, voiding diaries, questionnaires, and imaging or urodynamic measures as appropriate. The goal is to see if Neovasculgen reduces cicatricial changes after lesion treatment and helps preserve bladder capacity.

Who should consider this trial

Good fit: Women 18 to 65 with a confirmed diagnosis of interstitial cystitis/ painful bladder syndrome and visible Hunner's lesions on cystoscopy, with symptoms for at least 12 months and ability to comply with study procedures and contraception requirements.

Not a fit: People without Hunner's lesions, men, those with active urinary tract infection or other causes of their symptoms, or those unable to attend follow-up visits or keep required diaries are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, Neovasculgen could reduce scarring after lesion treatment, help preserve bladder volume, and improve pain and urinary symptoms.

How similar studies have performed: Neovasculgen has demonstrated benefit in peripheral arterial disease, but applying it to prevent bladder scarring in interstitial cystitis is a novel approach that has not been proven in large trials.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent prior to any study-related procedures.
2. Women aged 18 to 65 years, inclusive.
3. A confirmed diagnosis of painful bladder syndrome/interstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.
4. The presence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
5. A glycated hemoglobin level within the normal range for the patient's age group.
6. Ability to comply with all study requirements, in the opinion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.
7. Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.

Exclusion Criteria:

1. Any condition that prevents intravesical administration of medications.
2. Received medication or non-medication therapy, including physical therapy, for BPS/IC within 1 month prior to study inclusion.
3. Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.
4. History of chronic drug or alcohol abuse.
5. Pregnant women, planning to become pregnant during the study, or currently breastfeeding.
6. Any other conditions associated with pelvic pain, except for PBS.
7. Pelvic surgery less than 6 months prior to the study.
8. Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening.
9. History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.
10. Inability to discontinue anticoagulant/antiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low molecular weight heparin may be used for 3 days after investigational drug administration).
11. Diseases of the urinary tract/bladder (neoplasms, tuberculous and bacterial cystitis, urolithiasis, radiation injury, urethral diverticulum, neurogenic dysfunction of the lower urinary tract) and female genital organs (neoplasms, vaginitis, genital infections).
12. Other conditions that, in the opinion of the research physician, could become an objective obstacle to the patient's participation in the study and/or create additional risks for the patient.
13. A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.
14. Bladder capacity under anesthesia less than 150 ml.
15. Residual urine volume greater than 50 ml.

Where this trial is running

Moscow

• Botkin Hospital — Moscow, Russia (Recruiting)

Conditions IC; Hunner Type Interstitial Cystitis; Bladder Pain Syndrome