Bladder Pain Syndrome, Educational Behavioral Intervention, Urinary Urgency
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral: Educational and Behavioral Management Program (EBMP)
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.
DRUGIntervention
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | All adverse events throughout follow-up will be collected and graded as mild, moderate, severe, or life-threatening for safety evaluation |
| Changes in ICPI score | 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 |
| 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 | Serial PUF assessment (total score range: 0-40; higher scores indicate more severe pelvic urinary symptoms) to track symptom severity alterations. |
| Changes in ICSI score | 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 |
Contacts
CONTACTFang Luo doctor, doctor
Outcome results
None listed