Mirogabalin Plus EBMP for IC/BPS
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this 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:
1. Does combined mirogabalin and EBMP treatment produce better overall symptom improvement after 12 weeks compared with EBMP alone? 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older
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
Disqualifiers
Symptomatic urethral stricture
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
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral: Educational and Behavioral Management Program (EBMP)
BehavioralDescription: 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.
Intervention
DrugOral, 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Arm1: EBMP Only GroupOther 1 intervention
Group B: Arm 2：EBMP + Mirogabalin groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeks after intervention initiationSecondary outcomes
1
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.
Time frame
Time Frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 122
Changes in ICSI score
Score range 0-20, evaluating urinary symptoms including frequency, nocturia, urgency and pain
Time frame
Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 123
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
Time frame
Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 124
Changes in ICPI score
Score range 0-16, assessing distress triggered by urinary symptoms Unit of measure: Scale score
Time frame
Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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