Mirogabalin Plus EBMP for IC/BPS

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a multicenter, open‐label, parallel‐group, randomized controlled trial. A totalof 140 adult participants with physician‐diagnosed IC/BPS will be enrolled. Participantsare randomized 1:1 to receive either EBMP alone or EBMP combined with mirogabalin.Independent centralized randomization and sealed opaque envelopes ensure allocationconcealment. Outcome assessors are blinded to group assignment to minimize detectionbias.The intervention period lasts 12 weeks. Study assessments are conducted at baseline, week2, week 6, and week 12. The primary endpoint is patient‐reported global responseassessment at week 12. Secondary endpoints cover bladder pain, urinary diary parameters,validated symptom scales, quality of life, sleep function, depressive symptoms, andadverse 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.
Epistemonikos ID: 8bf87e5b3c500bd573cc36f51e2133f06a3ec96d
First added on: Sep 03, 2026