Bladder Pain SyndromePhase 1M-EBMP-IC/BPSNCT07803393
Mirogabalin Plus EBMP for IC/BPS
A Phase 1 study testing Behavioral: Educational and Behavioral Management Program (EBMP) and Intervention in people with Bladder Pain Syndrome and Educational Behavioral Intervention, run by Beijing Tiantan Hospital.
Trial summary
The goal of this clinical trial is to learn whether adding mirogabalin to educational-behavioral modification program (EBMP) improves symptoms and safety outcomes for adults living with interstitial cystitis/bladder pain syndrome (IC/BPS). The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Pain Syndrome, Educational Behavioral Intervention, Urinary Urgency
- What is being tested?
- Behavioral: Educational and Behavioral Management Program (EBMP) and Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 20 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with bladder pain syndrome/interstitial cystitis (IC/BPS) in accordance with diagnostic criteria released by AUA and ESSIC, with confounding disorders excluded through clinical workup
- Persistent urinary symptoms across most days in the latest 3 months prior to enrollment
- Participants report bladder pain/discomfort and urinary urgency/frequency scores ≥ 3 on the 0-10 Likert scale over the past 4 weeks
Who cannot join
- Active neurological diseases that impair bladder or intestinal function
- Active autoimmune disorders or infectious diseases
- History of cystitis secondary to tuberculosis, pelvic radiotherapy or pelvic chemotherapy
- Previous history of non-cutaneous malignant tumors
- Confirmed severe psychiatric disorders at present, including major depressive disorder, bipolar disorder, schizophrenia and other serious mental illnesses
- Severe systemic diseases featuring obvious dysfunction of the heart, lung, liver or kidney
Show all 10Show fewer
- Confirmed hypersensitivity to pregabalin
- Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Pregnancy status
- Lactation period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mirogabalin Combined With Educational-Behavioral Modification Program Versus Educational-Behavioral Modification Program Alone for Interstitial Cystitis/Bladder Pain Syndrome: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn whether adding mirogabalin to educational-behavioral modification program (EBMP) improves symptoms and safety outcomes for adults living with interstitial cystitis/bladder pain syndrome (IC/BPS).
The main questions this study aims to answer are:
Read more
- Does combined mirogabalin and EBMP treatment produce better overall symptom improvement after 12 weeks compared with EBMP alone?
- Is combination treatment safe and well-tolerated in adults with IC/BPS?
Researchers will compare two treatment groups to test these questions. Eligible adult participants will be randomly assigned in a 1-to-1 ratio to one of two groups. Randomization is performed through a certified online clinical trial platform with allocation concealment.
Participants will:
- Receive either standard EBMP alone or EBMP plus oral mirogabalin for 12 weeks
- Follow a flexible mirogabalin dosing schedule in the combination group, starting at a low dose and gradually increasing based on individual tolerance
- Complete regular clinic visits, bladder diaries, and symptom questionnaires at baseline, week 2, week 6, and week 12
- Undergo repeated assessments of pain, bladder function, quality of life, sleep status, and mood during treatment
This is an open-label study, meaning participants and treating clinicians know the assigned treatment. To avoid assessment bias, outcome evaluators remain blinded to group allocation throughout the trial.
The primary study outcome is participants' overall symptom response after 12 weeks of treatment. Secondary outcomes include changes in bladder pain, urinary frequency, functional bladder capacity, IC/BPS-specific symptoms, quality of life, sleep quality, and depressive symptoms. The study also monitors all adverse events to evaluate treatment safety over 12 weeks.
Read the detailed description
This is a multicenter, open-label, parallel-group, randomized controlled trial. A total of 140 adult participants with physician-diagnosed IC/BPS will be enrolled. Participants are randomized 1:1 to receive either EBMP alone or EBMP combined with mirogabalin. Independent centralized randomization and sealed opaque envelopes ensure allocation concealment. Outcome assessors are blinded to group assignment to minimize detection bias.
The intervention period lasts 12 weeks. Study assessments are conducted at baseline, week 2, week 6, and week 12. The primary endpoint is patient-reported global response assessment at week 12. Secondary endpoints cover bladder pain, urinary diary parameters, validated symptom scales, quality of life, sleep function, depressive symptoms, and adverse event profiles.
Statistical analyses will adopt both intention-to-treat and per-protocol analysis sets. Sample size calculation was performed using PASS 11 software with consideration of a 10% dropout rate to ensure statistical power.
- Being tested
- Behavioral: Educational and Behavioral Management Program (EBMP), Intervention
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Educational and Behavioral Management Program (EBMP)Behavioural
Description: Standardized educational and behavioral intervention for IC/BPS patients, including bladder health education, dietary adjustment guidance, pelvic floor behavioral training, lifestyle modification and regular follow-up counseling. Identical EBMP content is delivered to participants in both study arms throughout the 12-week trial period.
InterventionDrug
Oral, starting dose 5 mg twice daily (Bid). Titrate by 5 mg Bid every week up to maximum 15 mg Bid, based on tolerability. Maintain the maximum tolerated dose (MTD) for total 12-week treatment. Dose reduction permitted for intolerable adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: EBMP Only Group | Other | Behavioral：Educational-Behavioral Modification Program (EBMP) Receives: Behavioral: Behavioral: Educational and Behavioral Management Program (EBMP) |
| Arm 2：EBMP + Mirogabalin group | Experimental | Oral, starting dose 5 mg twice daily (Bid). Titrate by 5 mg Bid every week up to maximum 15 mg Bid, based on tolerability. Maintain the maximum tolerated dose (MTD) for total 12-week treatment. Dose reduction permitted for intolerable adverse events. Receives: Drug: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)
The 7-point patient-reported GRA scale evaluates overall treatment well-being, with response categories: markedly worse, moderately worse, slightly worse, unchanged, slightly improved, moderately improved, markedly improved. Participants reporting moderately improved or markedly improved outcomes are defined as treatment responders. We compare responder proportions between the two randomized groups.
Measured: 12 weeks after intervention initiation
Secondary outcomes (4)
2. Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores
Serial PUF assessment (total score range: 0-40; higher scores indicate more severe pelvic urinary symptoms) to track symptom severity alterations.
Measured: Time Frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICSI score
Score range 0-20, evaluating urinary symptoms including frequency, nocturia, urgency and pain
Measured: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Incidence and Severity Grading of Adverse Events
All adverse events throughout follow-up will be collected and graded as mild, moderate, severe, or life-threatening for safety evaluation
Measured: Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICPI score
Score range 0-16, assessing distress triggered by urinary symptoms Unit of measure: Scale score
Measured: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Pain SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803393
- Sponsor's protocol ID
- 2026YJSKTPG-03
- Acronym
- M-EBMP-IC/BPS
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decisions on individual participant data (IPD) sharing have not been finalized at the current trial registration stage. The research team will assess institutional data policies, patient privacy constraints, and future collaborative demands later during the trial. Any formal data-sharing arrangements will be updated promptly on ClinicalTrials.gov once confirmed.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirogabalin Combined With Educational-Behavioral Modification Program Versus Educational-Behavioral Modification Program Alone for Interstitial Cystitis/Bladder Pain Syndrome: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07803393
- Acronym / sponsor ID
- M-EBMP-IC/BPS / 2026YJSKTPG-03
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 3 Sep 2026 (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.
The goal of this clinical trial is to learn whether adding mirogabalin to educational-behavioral modification program (EBMP) improves symptoms and safety outcomes for adults living with interstitial cystitis/bladder pain syndrome (IC/BPS).
The main questions this study aims to answer are:
- Does combined mirogabalin and EBMP treatment produce better overall symptom improvement after 12 weeks compared with EBMP alone?
- Is combination treatment safe and well-tolerated in adults with IC/BPS?
Researchers will compare two treatment groups to test these questions. Eligible adult participants will be randomly assigned in a 1-to-1 ratio to one of two groups. Randomization is performed through a certified online clinical trial platform with allocation concealment.
Participants will:
- Receive either standard EBMP alone or EBMP plus oral mirogabalin for 12 weeks
- Follow a flexible mirogabalin dosing schedule in the combination group, starting at a low dose and gradually increasing based on individual tolerance
- Complete regular clinic visits, bladder diaries, and symptom questionnaires at baseline, week 2, week 6, and week 12
- Undergo repeated assessments of pain, bladder function, quality of life, sleep status, and mood during treatment
This is an open-label study, meaning participants and treating clinicians know the assigned treatment. To avoid assessment bias, outcome evaluators remain blinded to group allocation throughout the trial.
The primary study outcome is participants' overall symptom response after 12 weeks of treatment. Secondary outcomes include changes in bladder pain, urinary frequency, functional bladder capacity, IC/BPS-specific symptoms, quality of life, sleep quality, and depressive symptoms. The study also monitors all adverse events to evaluate treatment safety over 12 weeks.
Detailed description
This is a multicenter, open-label, parallel-group, randomized controlled trial. A total of 140 adult participants with physician-diagnosed IC/BPS will be enrolled. Participants are randomized 1:1 to receive either EBMP alone or EBMP combined with mirogabalin. Independent centralized randomization and sealed opaque envelopes ensure allocation concealment. Outcome assessors are blinded to group assignment to minimize detection bias.
The intervention period lasts 12 weeks. Study assessments are conducted at baseline, week 2, week 6, and week 12. The primary endpoint is patient-reported global response assessment at week 12. Secondary endpoints cover bladder pain, urinary diary parameters, validated symptom scales, quality of life, sleep function, depressive symptoms, and adverse event profiles.
Statistical analyses will adopt both intention-to-treat and per-protocol analysis sets. Sample size calculation was performed using PASS 11 software with consideration of a 10% dropout rate to ensure statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1: EBMP Only Group | Other | Behavioral: Behavioral: Educational and Behavioral Management Program (EBMP)Behavioral：Educational-Behavioral Modification Program (EBMP) |
| Arm 2：EBMP + Mirogabalin group | Experimental | Drug: InterventionOral, starting dose 5 mg twice daily (Bid). Titrate by 5 mg Bid every week up to maximum 15 mg Bid, based on tolerability. Maintain the maximum tolerated dose (MTD) for total 12-week treatment. Dose reduction permitted for intolerable adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosed with bladder pain syndrome/interstitial cystitis (IC/BPS) in accordance with diagnostic criteria released by AUA and ESSIC, with confounding disorders excluded through clinical workup
- Persistent urinary symptoms across most days in the latest 3 months prior to enrollment
- Participants report bladder pain/discomfort and urinary urgency/frequency scores ≥ 3 on the 0-10 Likert scale over the past 4 weeks
Key exclusion criteria (10 listed)
- Active neurological diseases that impair bladder or intestinal function
- Active autoimmune disorders or infectious diseases
- History of cystitis secondary to tuberculosis, pelvic radiotherapy or pelvic chemotherapy
- Previous history of non-cutaneous malignant tumors
- Confirmed severe psychiatric disorders at present, including major depressive disorder, bipolar disorder, schizophrenia and other serious mental illnesses
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 |
|---|---|---|
| Behavioral: Educational and Behavioral Management Program (EBMP)Description: Standardized educational and behavioral intervention for IC/BPS patients, including bladder health education, dietary adjustment guidance, pelvic floor behavioral training, lifestyle modification and regular follow-up counseling. Identical EBMP content is delivered to participants in both study arms throughout the 12-week trial period. | Behavioural | Arm1: EBMP Only Group |
| InterventionOral, starting dose 5 mg twice daily (Bid). Titrate by 5 mg Bid every week up to maximum 15 mg Bid, based on tolerability. Maintain the maximum tolerated dose (MTD) for total 12-week treatment. Dose reduction permitted for intolerable adverse events. | Drug | Arm 2：EBMP + Mirogabalin group |
Primary outcome
1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)
Time frame: 12 weeks after intervention initiation
The 7-point patient-reported GRA scale evaluates overall treatment well-being, with response categories: markedly worse, moderately worse, slightly worse, unchanged, slightly improved, moderately improved, markedly improved. Participants reporting moderately improved or markedly improved outcomes are defined as treatment responders. We compare responder proportions between the two randomized groups.
4 secondary outcomes
2. Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores
Time frame: Time Frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICSI score
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Incidence and Severity Grading of Adverse Events
Time frame: Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICPI score
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided. Decisions on individual participant data (IPD) sharing have not been finalized at the current trial registration stage. The research team will assess institutional data policies, patient privacy constraints, and future collaborative demands later during the trial. Any formal data-sharing arrangements will be updated promptly on ClinicalTrials.gov once confirmed.
Related trials for Bladder Pain Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Behavioral: Educational and Behavioral Management Program (EBMP) and Intervention in people with Bladder Pain Syndrome and Educational Behavioral Intervention, run by Beijing Tiantan 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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo doctor, doctor (+8615560392365, Litypacop@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA) (time frame: 12 weeks after intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.