Interstitial CystitisPhase 2/3NCT05912946
Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis
A Phase 2/3 study testing Interferon, Sodium Hyaluronate and Sodium Chloride Injection in people with Interstitial Cystitis, run by West China Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Interferon, Sodium Hyaluronate and Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2023to 15 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis: a Randomized, Double-blind, Placebo-controlled Study
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.
Read the 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.
- Conditions
- Interstitial Cystitis
- Being tested
- Interferon, Sodium Hyaluronate, Sodium Chloride Injection
- Keywords
- Interstitial cystitis, Interferon, Bladder infusion
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterferonDrug
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.
Sodium HyaluronateDrug
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 Chloride InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Treatment-related complications, such as urinary tract infections, pain, psychiatric symptoms, changes in liver and kidney function, and gastrointestinal symptoms.
Measured: The time frame was from the date of bladder infusion to the date of final follow-up, ranging from 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De-yi Luo, West China Hospital
- Investigators
- Wei-min Li, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912946
- Sponsor's protocol ID
- 2022370
- Status last verified
- Sep 2023
- First submitted
- 30 May 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38587846
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05912946
- Acronym / sponsor ID
- 2022370
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial cystitis, Interferon, Bladder infusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group drug | Experimental | Drug: InterferonGeneric 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. |
| Sodium Hyaluronate | Active comparator | Drug: Sodium HyaluronateGeneric 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. |
| Sodium chloride injection | Placebo comparator | Drug: Sodium Chloride InjectionGeneric 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterferonThe 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. | Drug | Experimental group drug |
| Sodium HyaluronateThe 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. | Drug | Sodium Hyaluronate |
| Sodium Chloride InjectionThe 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. | Drug | Sodium chloride injection |
Primary outcome
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 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.
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.
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 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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 38587846Shen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-min Li study chair
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Interferon, Sodium Hyaluronate and Sodium Chloride Injection in people with Interstitial Cystitis, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sihong Shen (+8615757400692, 760223213@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.