RecruitingPhase 2/3

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

Russia180 participantsStarted 2024-02-16

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Written informed consent prior to any study-related procedures.
✓. Women aged 18 to 65 years, inclusive.

Exclusion criteria

✕. Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
✕. A glycated hemoglobin level within the normal range for the patient's age group.
✕. 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.
✕. Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.
✕. 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.

What they're measuring

"Number of Participants with Treatment-Related effect according to the protocol through study completion, on average, over 1 year.

Timeframe: Until the end of the study

Trial details

NCT IDNCT07391306

SponsorJSC NextGen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

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