drugset / Trial / NCT05912946

Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis

NCT05912946

Phase 2/3 Unknown 129 enrolled West China Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Interstitial cystitis/bladder pain syndrome (IC/BPS) is one of the most intractable diseases of Urogynecology. The main clinical manifestations of interstitial cystitis/bladder pain are frequent urination and severe overflowing bladder pain. Due to the unclear pathological mechanism and the diversity of clinical manifestations and pathological features of the disease, the diagnosis is mainly to exclude suspicious diseases. At present, IC/BPS treatment mainly includes oral administration of mast cell stabilizing drugs such as sodium pentosan sulfate and anticholinergic drugs, or bladder instillation of dimethyl sulfone, hyaluronic acid and other drugs directly acting on the bladder mucosa, or surgical treatment such as sacrospinal radiculotomy and peripheral denervation of the bladder, but all can only relieve clinical symptoms and improve quality of life, and can not be targeted etiological treatment according to the pathological mechanism. Research showed JC polyomavirus (JCPyV) virus may be the original pathogen causing the development of IC/BPS. Interferon, as a broad-body antiviral agent, plays a critical role in triggering innate and adaptive immune responses against viral replication and infection. It can inhibit the replication and transcription of JCPyV through a variety of pathways. Interferon may be a potential specific drug for IC/BPS. Therefore, this study aims to evaluate the efficacy and safety of interferon bladder perfusion for IC/BPS.

Timeline

Start
2023-10-15
Primary completion
2024-10-15
Completion
2024-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Hyaluronate Other / unclassified 40 mg Other
Subject interferon alfa-2b Protein / enzyme biologic 3e+06 iu Other

Indications