RecruitingPhase 2/3

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

Russia180 participantsStarted 2023-12-29

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. The presence 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, in the opinion 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants who experienced a treatment effect at study end, within 1 year from treatment start to study end.

Timeframe: within 1 year from treatment start to study end

Trial details

NCT IDNCT07459790

SponsorJSC NextGen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-30

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