Clinical trial
Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis: a Randomized, Double-blind, Placebo-controlled Study
Name
2022370
Description
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.
Trial arms
Trial start
2023-10-15
Estimated PCD
2024-10-15
Trial end
2024-10-15
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Experimental group 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.
Arms:
Sodium Hyaluronate
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.
Arms:
Sodium chloride injection
Size
129
Primary endpoint
The score of global response assessment (GRA) pre- and post-treatment
The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
The score of visual analogue scale (VAS) pre- and post-treatment
The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
Interstitial Cystitis Symptom Average Index (ICSI) questionnaires pre- and post-treatment
The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
Interstitial Cystitis Problem Average Index (ICPI) questionnaires pre- and post-treatment
The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
The score of pelvic pain and urgency/frequency (PUF) pre- and post-treatment
The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
Eligibility criteria
Inclusion Criteria:
* Patients over 18 years old, regardless of gender
* Combined with bladder pain/discomfort during urination, and at least one lower urinary tract symptom such as frequency and urgency, duration \> 6 months
* The total score of O'Leary-Sant ICSI+ICPI is more than 18 points
* Agree to receive bladder perfusion therapy
Exclusion Criteria:
* Have a history of allergy to interferon drugs
* Patients with serious heart, lung, liver, kidney or blood diseases, abnormal liver function, renal insufficiency, etc.
* Pregnant or lactating women
* A history of urinary tract infection within 12 weeks
* IC/ BPS-like symptoms caused by urinary diseases, such as overactive bladder, neurogenic bladder, urinary calculi, radiation cystitis, and endometriosis
* Within 24 weeks, patients had the following treatment history: bladder hydrodilation, intravesical laser treatment, pelvic floor reconstruction surgery
* Patients who have taken related drugs or participated in other clinical studies and received study drugs or medical device interventions within 3 months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 129, 'type': 'ESTIMATED'}}
Updated at
2023-09-15
1 organization
3 products
1 indication
Organization
West China HospitalProduct
InterferonIndication
Interstitial CystitisProduct
Sodium HyaluronateProduct
Sodium Chloride