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

NCT07459790 | Recruiting Phase 2 DMC

• 1 other identifier: 01-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 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.

Conditions

IC; Hunner Type Interstitial Cystitis; Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

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

  Conclusions about the effectiveness of treatment will be made based on the results of cystoscopies, patient complaints and questionnaire results.

  within 1 year from treatment start to study end

Study Arms (2)

The investigational therapy group (Neovasculgen)

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

Neovasculgen® DRUG

The bladder is hydro-bougienated, Hunner's lesions are identified, and electrocoagulation is performed using a resectoscope using standard techniques, followed by repeated hydro-bougienage of the bladder. The drug/placebo is then administered using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder. The drug/placebo is injected evenly along the edges of the coagulated area and into the Hunner's lesion itself, and then evenly along the bladder walls in a series of 30 injections.

The investigational therapy group (Neovasculgen)

Placebo DRUG

The bladder is hydro-bougienated, Hunner's lesions are identified, and electrocoagulation is performed using a resectoscope using standard techniques, followed by repeated hydro-bougienage of the bladder. The drug/placebo is then administered using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder. The drug/placebo is injected evenly along the edges of the coagulated area and into the Hunner's lesion itself, and then evenly along the bladder walls in a series of 30 injections.

Placebo 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.
• 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.

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 PBS.
• 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 12, 2026
• First Posted: March 10, 2026
• Study Start: December 29, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)