NCT05912946

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

Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis: a Randomized, Double-blind, Placebo-controlled Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The main manifestations of IC/BPS patients are pain, pressure or discomfort related to the bladder. Due to the unclear pathogenesis and inconsistent diagnostic criteria, accurate and effective clinical diagnosis and treatment of IC/BPS become very difficult. The diagnosis of IC/BPS is often uncertain and delayed, with patients moving from one hospital to another, often taking 2-11 years to get a final diagnosis. At present, the treatment of IC/BPS is mostly aimed at relieving clinical symptoms (including drugs, bladder perfusion, sacral nerve regulation, etc.), instead of radical treatment based on pathological mechanism. However, the long-term follow-up effect of commonly used clinical treatment is not good, with a recurrence rate of 70%. And about 10% of patients will eventually choose bladder resection because of the physical torture and mental stress caused by the disease. Previous studies confirmed that the positive rate of JCPyV in the urine of IC/BPS patients was 95%, while no JCPYV was found in the control group, suggesting that JCPYV may play an important role in the pathological mechanism of IC/BPS. The literature review also confirmed the presence of BK polyomaviruses (BKPyV) and JCPyV in IC/BPS urine, and a case of bladder perfusion therapy with interferon was reported to alleviate the frequency of urination and pain symptoms in IC/BPS patients, suggesting that interferon may be a potential specific drug for IC/BPS treatment. However, there are basically no relevant clinical studies at present. Therefore, this study aims to explore the efficacy and safety of interferon intravesical infusion therapy for IC/BPS. The research results are expected to improve the existing therapeutic means and explore new therapeutic targets. It lays an important foundation for the accurate treatment of IC/BPS.

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	Interferon	The patient was seated in the seat and rested quietly. A three-way urinary tube was indwelled to drain urine. Interferon solution was configured according to the ratio of 3 million IU interferon +49ml normal saline. The urinary tube was clamped and the interferon solution was injected through the water inlet tube and retained for 30 minutes.
DRUG	Sodium Hyaluronate	The patient was seated in the seat and rested quietly. A three-way urinary tube was indwelled to drain urine. The urinary tube was clamped and the sterile sodium hyaluronate solution was injected through the water inlet tube and retained for 30 minutes.
DRUG	Sodium Chloride Injection	The patient was seated in the seat and rested quietly. A three-way urinary tube was indwelled to drain urine. The urinary tube was clamped and the sodium chloride injection was injected through the water inlet tube and retained for 30 minutes.

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2023-06-22
• Last updated: 2023-09-15