Actively Recruiting
The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.
Led by JSC NextGen · Updated on 2026-02-05
180
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner's Lesions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 65 years
- Written informed consent before any study procedures
- Confirmed diagnosis of painful bladder syndrome/interstitial cystitis with pelvic pain and frequent urination lasting at least 12 months
- No Hunner's lesions in the bladder during cystoscopy with hydrobougienage
- Normal glycated hemoglobin level for age
- Ability to comply with study requirements including voiding diary, questionnaires, and visits
- Negative pregnancy test and use of reliable contraception for women of childbearing potential
You will not qualify if you...
- Any condition preventing intravesical medication administration
- Received medication or non-medication therapy for BPS/IC within 1 month before study
- Instillation of any bladder pharmacological agent less than 1 month before screening
- History of chronic drug or alcohol abuse
- Pregnant, planning pregnancy, or breastfeeding
- Other conditions causing pelvic pain besides BPS
- Pelvic surgery less than 6 months before the study
- Intravesical procedures except diagnostic cystoscopy less than 3 months before screening
- Allergy or intolerance to anesthetic or antibiotics used in the study
- Inability to stop anticoagulants/antiplatelets as required around drug administration
- Urinary tract/bladder diseases such as neoplasms, infections, stones, radiation injury, urethral diverticulum, or neurogenic dysfunction
- Diseases of female genital organs like neoplasms, vaginitis, or infections
- Any condition that may hinder study participation or increase risks as judged by the physician
- Intravesical botulinum therapy within 12 months before 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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