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

Официальное название

Double-blind, Placebo-controlled, Adaptive, Multicenter, Prospective, Randomized, Comparative, Parallel-group Study of the Efficacy and Safety of Neovasculgen (Plasmid Supercoiled Deoxyribonucleic Acid pCMV-VEGF165) in Painful Bladder Syndrome/Interstitial Cystitis (BPS/IC)

Обзор

To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.

Вмешательства

• Препарат Neovasculgen®
  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.
• Препарат Placebo
  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.

Первичные конечные точки

• "Number of Participants with Treatment-Related effect according to the protocol through study completion, on average, over 1 year. [Срок оценки: Until the end of the study]

Критерии участия

Критерии включения

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

Критерии исключения

• Any condition that prevents intravesical administration of medications.
• Received medication or non-medication therapy, including physical therapy, for BPS/IC within 1 month prior to study inclusion.
• 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.
• A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.
• Bladder capacity under anesthesia less than 150 ml.
• Residual urine volume greater than 50 ml.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• Botkin Hospital — Moscow

Идентификаторы

NCT: NCT07391306 · 02-InterCis-NVG-III

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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