- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Sihong Shen
- Phone Number: +8615757400692
- Email: 760223213@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group drug
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.
|
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.
|
Active Comparator: Sodium Hyaluronate
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.
|
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.
|
Placebo Comparator: Sodium chloride injection
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The score of global response assessment (GRA) pre- and post-treatment
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
|
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 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
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
|
The score of VAS ranging from 0 to 10. Higher scores indicate higher levels of pain.
|
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
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
|
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. |
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
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
|
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 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
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
|
The score ranges from 0 to 35 points.
A score ≥5 points is considered to indicate IC.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related complications
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
|
Treatment-related complications, such as urinary tract infections, pain, psychiatric symptoms, changes in liver and kidney function, and gastrointestinal symptoms.
|
The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Wei-min Li, West China Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Cystitis
- Cystitis, Interstitial
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Viscosupplements
- Interferons
- Hyaluronic Acid
Other Study ID Numbers
- 2022370
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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