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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorJSC NextGen

About this trial

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

Eligibility criteria

Qualifiers

Written informed consent prior to any study-related procedures.

Women aged 18 to 65 years, inclusive.

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.

Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).

Disqualifiers

Any condition that prevents intravesical administration of medications.

Received medication or non-medication therapy, including physical therapy, for BPS/IC within 1 month prior to study inclusion.

Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.

History of chronic drug or alcohol abuse.

Trial design

Treatments tested in this trial

  • Neovasculgen®
  • Placebo

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators