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 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

✕. 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.
✕. 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 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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