Mirogabalin Combined With Educational-Behavioral Modification Program Versus Educational-Behavioral Modification Program Alone for Interstitial Cystitis/Bladder Pain Syndrome: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- 1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm1: EBMP Only Group
Behavioral：Educational-Behavioral Modification Program (EBMP)
干预措施: Behavioral: Educational and Behavioral Management Program (EBMP) (Behavioral)
Arm 2：EBMP + Mirogabalin group
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.
干预措施: Intervention (Drug)
结局指标
主要结局
1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)
时间窗: 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.
次要结局
- 2. Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores(Time Frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12)
- Changes in ICSI score(Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12)
- Incidence and Severity Grading of Adverse Events(Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12)
- Changes in ICPI score(Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12)
研究者
Fang Luo
Dotocr
Beijing Tiantan Hospital