ClinicalTrials.gg
RecruitingNCT07391306Updated Feb 5, 2026

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

A Phase 2/3 interventional study of Neovasculgen® and Placebo in IC, Interstitial Cystitis and Bladder Pain Syndrome and Interstitial Cystitis, Chronic, sponsored by JSC NextGen. Recruiting at 1 site in Russia. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by JSC NextGen · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Feb 2024, registered Jan 2026).
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • IC
  • Interstitial Cystitis and Bladder Pain Syndrome
  • Interstitial Cystitis, Chronic
03

In context

Cystitis, Interstitial

236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.

This study's planned enrollment of 180 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.

Browse Cystitis, Interstitial studies →

Lead sponsor

JSC NextGen is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written 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. Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
  5. A level within the normal range for the patient's age group.
  6. 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.
  7. Women who are of must have negative pregnancy test results and must use reliable throughout their participation in the study.

Exclusion criteria

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 BPS
  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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    The investigational therapy group

    Receiving combination therapy: coagulation of Hunner's lesions of the bladder followed by hydrobougienage and intradetrusor administration of Neovasculgen

    Drug: Neovasculgen®

  • Placebo comparator
    Placebo group

    Control group, receiving basic therapy: coagulation of Hunner's lesions of the bladder followed by hydrobougienage

    Drug: Placebo

Interventions

  • The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder.

  • DrugPlacebo

    The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder.

06

What researchers measure

Primary outcomes

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

    Time frame: Until the end of the study

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07391306
Lead sponsor
JSC NextGen
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Feb 16, 2024
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Feb 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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