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

Primary Purpose

Interstitial Cystitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Interferon
Sodium Hyaluronate
Sodium Chloride Injection
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Interferon, Bladder infusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Experimental group drug

    Sodium Hyaluronate

    Sodium chloride injection

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    The score of global response assessment (GRA) pre- and post-treatment
    The primary treatment outcomes were assessed using the Global Response Assessment (GRA) score (categorized into - 3, - 2, - 1, 0, 1, 2, and 3, indicating markedly worse to markedly improved status)
    The score of visual analogue scale (VAS) pre- and post-treatment
    The score of VAS ranging from 0 to 10. Higher scores indicate higher levels of pain.
    Interstitial Cystitis Symptom Average Index (ICSI) questionnaires pre- and post-treatment
    The O'Leary-Sant instrument is comprised of Symptom Index (score range: 0-20 points), which contains four questions related to urinary and pain symptoms. The score is calculated by summing the points for each item, and a score ≥6 points indicates IC.
    Interstitial Cystitis Problem Average Index (ICPI) questionnaires pre- and post-treatment
    The O'Leary-Sant instrument is comprised of Problem Index (score range: 0-16 points), which contains four questions related to urinary and pain symptoms. The score is calculated by summing the points for each item, and a score ≥6 points indicates IC.
    The score of pelvic pain and urgency/frequency (PUF) pre- and post-treatment
    The score ranges from 0 to 35 points. A score ≥5 points is considered to indicate IC.

    Secondary Outcome Measures

    Treatment-related complications
    Treatment-related complications, such as urinary tract infections, pain, psychiatric symptoms, changes in liver and kidney function, and gastrointestinal symptoms.

    Full Information

    First Posted
    May 30, 2023
    Last Updated
    September 14, 2023
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05912946
    Brief Title
    Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis
    Official Title
    Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis: a Randomized, Double-blind, Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2024 (Anticipated)
    Study Completion Date
    October 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Cystitis
    Keywords
    Interstitial cystitis, Interferon, Bladder infusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    129 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group drug
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sodium Hyaluronate
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Sodium chloride injection
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Interferon
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Hyaluronate
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Chloride Injection
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The score of global response assessment (GRA) pre- and post-treatment
    Description
    The primary treatment outcomes were assessed using the Global Response Assessment (GRA) score (categorized into - 3, - 2, - 1, 0, 1, 2, and 3, indicating markedly worse to markedly improved status)
    Time Frame
    The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
    Title
    The score of visual analogue scale (VAS) pre- and post-treatment
    Description
    The score of VAS ranging from 0 to 10. Higher scores indicate higher levels of pain.
    Time Frame
    The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
    Title
    Interstitial Cystitis Symptom Average Index (ICSI) questionnaires pre- and post-treatment
    Description
    The O'Leary-Sant instrument is comprised of Symptom Index (score range: 0-20 points), which contains four questions related to urinary and pain symptoms. The score is calculated by summing the points for each item, and a score ≥6 points indicates IC.
    Time Frame
    The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
    Title
    Interstitial Cystitis Problem Average Index (ICPI) questionnaires pre- and post-treatment
    Description
    The O'Leary-Sant instrument is comprised of Problem Index (score range: 0-16 points), which contains four questions related to urinary and pain symptoms. The score is calculated by summing the points for each item, and a score ≥6 points indicates IC.
    Time Frame
    The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
    Title
    The score of pelvic pain and urgency/frequency (PUF) pre- and post-treatment
    Description
    The score ranges from 0 to 35 points. A score ≥5 points is considered to indicate IC.
    Time Frame
    The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
    Secondary Outcome Measure Information:
    Title
    Treatment-related complications
    Description
    Treatment-related complications, such as urinary tract infections, pain, psychiatric symptoms, changes in liver and kidney function, and gastrointestinal symptoms.
    Time Frame
    The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sihong Shen
    Phone
    +8615757400692
    Email
    760223213@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei-min Li
    Organizational Affiliation
    West China Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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