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

NCT07391306 | Recruiting Phase 2 DMC

• 1 other identifier: 02-InterCis-NVG-III
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Cystitis, Chronic; IC; Interstitial Cystitis and Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

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

  Until the end of the study

Study Arms (2)

The investigational therapy group

EXPERIMENTAL

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

Drug: Neovasculgen®

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo group

Neovasculgen® DRUG

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.

The investigational therapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any condition that prevents intravesical administration of medications.
• Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.
• History of chronic drug or alcohol abuse.
• Pregnant women, planning to become pregnant during the study, or currently breastfeeding.
• Any other conditions associated with pelvic pain, except for BPS
• Pelvic surgery less than 6 months prior to the study
• Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening
• History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.
• 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).
• 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).
• 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.
• Bladder capacity under anesthesia less than 150 ml.
• Residual urine volume greater than 50 ml.

Sponsors & Collaborators

• JSC NextGen: lead

Study Sites (1)

Botkin Hospital

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 5, 2026
• Study Start: February 16, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

RU (1)