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

NCT05912946 | Unknown Phase 2 DMC

• 1 other identifier: 2022370
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Interstitial Cystitis

Keywords

Interstitial cystitis; Interferon; Bladder infusion

Outcome Measures

Primary Outcomes (5)

• 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 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 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

  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

  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

  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 Outcomes (1)

• Treatment-related complications

  The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months

Study Arms (3)

Experimental group drug

EXPERIMENTAL

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.

Drug: Interferon

Sodium Hyaluronate

ACTIVE COMPARATOR

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.

Drug: Sodium Hyaluronate

Sodium chloride injection

PLACEBO COMPARATOR

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.

Drug: Sodium Chloride Injection

Interventions

Interferon DRUG

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.

Experimental group drug

Sodium Hyaluronate DRUG

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.

Sodium Hyaluronate

Sodium Chloride Injection DRUG

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.

Sodium chloride injection

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (1)

• Shen SH, Peng L, Zeng X, Zhang J, Shen H, Luo DY. Intravesical Interferon Therapy vs Hyaluronic Acid for Pain Among Female Individuals With Interstitial Cystitis: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e244880. doi: 10.1001/jamanetworkopen.2024.4880.

  PMID: 38587846 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Interferons; Hyaluronic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wei-min Li

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Sihong Shen

CONTACT

+8615757400692; 760223213@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: October 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09