Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis
Interstitial Cystitis
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Interferon, Bladder infusion
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Experimental group drug
Sodium Hyaluronate
Sodium chloride injection
Generic name: Human interferon a2b injection; Dosage form: solution; Dosage: 1ml: 3 million IU; Frequency and duration: The first 4 weeks were irrigated once a week, a total of 4 times, and the last 4 months were irrigated once a month, a total of 4 times. The total treatment cycle was 5 months, and a total of 8 bladder perfusion treatments were performed.
Generic name: Sterile sodium hyaluronate solution; Dosage form: solution; Dosage: 40mg/50ml; Frequency and duration: The first 4 weeks were irrigated once a week, a total of 4 times, and the last 4 months were irrigated once a month, a total of 4 times. The total treatment cycle was 5 months, and a total of 8 bladder perfusion treatments were performed.
Generic name: Sodium chloride injection; Dosage form: solution; Dosage: 50ml: 0.45g; Frequency and duration: The first 4 weeks were irrigated once a week, a total of 4 times, and the last 4 months were irrigated once a month, a total of 4 times. The total treatment cycle was 5 months, and a total of 8 bladder perfusion treatments were performed.