Gene therapy aims to stop bladder scarring in painful bladder condition
NCT ID NCT07459790
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a gene therapy called Neovasculgen in 180 women with painful bladder syndrome and Hunner's lesions. The goal is to reduce scarring from previous treatments and prevent the bladder from shrinking. Participants receive either the drug or a placebo, and doctors check results using bladder cameras and symptom surveys over one year.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. The presence 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, in the opinion 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 PBS. 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 become an objective obstacle to the patient's participation in the study and/or create additional risks for the patient. 13. A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study. 14. Bladder capacity under anesthesia less than 150 ml. 15. Residual urine volume greater than 50 ml.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Botkin Hospital
RECRUITINGMoscow, Russia
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