Mirogabalin Plus EBMP for IC/BPS

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:

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.

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.

Inclusion Criteria:- 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

Exclusion Criteria:- 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
• 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
• Confirmed hypersensitivity to pregabalin
• Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Pregnancy status
• Lactation period