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The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.

RecruitingPhase 2, Phase 3NCT07391306
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.

Study details

Official title
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)
Conditions
  • IC
  • Interstitial Cystitis and Bladder Pain Syndrome
  • Interstitial Cystitis, Chronic
Interventions
Sponsor
JSC NextGen
Start date
2024-02-16
Primary completion
2027-05-31
Sex
Female
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Russia
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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. Absence 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, at the discretion 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 BPS 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 be…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07391306