Actively Recruiting
The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions
Led by JSC NextGen · Updated on 2026-03-10
180
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before study procedures
- Female aged 18 to 65 years
- Confirmed painful bladder syndrome/interstitial cystitis with pelvic pain and frequent urination lasting at least 12 months
- Presence of Hunner's lesions identified during cystoscopy with hydrobougienage
- Glycated hemoglobin level within normal range for age
- Ability to comply with study requirements including diaries, questionnaires, and visits
- Negative pregnancy test and use of reliable contraception if of childbearing potential
You will not qualify if you...
- Any condition preventing intravesical medication administration
- Received medication or physical therapy for bladder condition within 1 month prior to study
- Instillation of pharmacological agents into bladder less than 1 month before screening
- History of chronic drug or alcohol abuse
- Pregnant, planning pregnancy, or breastfeeding
- Other pelvic pain conditions besides painful bladder syndrome
- Pelvic surgery less than 6 months before study
- Intravesical procedures other than diagnostic cystoscopy less than 3 months before screening
- Allergy or intolerance to anesthetics or antibiotics planned for use
- Inability to stop anticoagulant/antiplatelet drugs 5 days before and resume 4 days after investigational drug administration
- Diseases of urinary tract/bladder or female genital organs such as neoplasms, infections, or neurogenic dysfunction
- Other conditions posing risks or obstacles to participation as judged by physician
- Intravesical botulinum therapy within 12 months prior to inclusion
- Bladder capacity under anesthesia less than 150 ml
- Residual urine volume greater than 50 ml
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Botkin Hospital
Moscow, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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