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NCT Number: NCT07803393

Mirogabalin Plus EBMP for IC/BPS

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.

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Key information

Conditions

Bladder Pain Syndrome Cystitis Cystitis, Interstitial Educational Behavioral Intervention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urinary Urgency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral: Educational and Behavioral Management Program (EBMP)

Behavioral

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.

Intervention

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Serial PUF assessment (total score range: 0-40; higher scores indicate more severe pelvic urinary symptoms) to track symptom severity alterations.

  2. Changes in ICSI score

    Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

    Score range 0-20, evaluating urinary symptoms including frequency, nocturia, urgency and pain

  3. 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

    All adverse events throughout follow-up will be collected and graded as mild, moderate, severe, or life-threatening for safety evaluation

  4. Changes in ICPI score

    Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

    Score range 0-16, assessing distress triggered by urinary symptoms Unit of measure: Scale score

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo doctor, doctor

CONTACT

[email protected]

+8615560392365

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study 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

Acronym: M-EBMP-IC/BPS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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