A Phase 1 interventional study of Behavioral: Educational and Behavioral Management Program (EBMP) and Intervention in Bladder Pain Syndrome, Educational Behavioral Intervention and Urinary Urgency, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Beijing Tiantan Hospital · Phase 1, Interventional, and Treatment
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:
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:
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 200 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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Inclusion Criteria:- Adults aged 18 years and older
Exclusion Criteria:- Symptomatic urethral stricture
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral：Educational-Behavioral Modification Program (EBMP)
Behavioral: Behavioral: Educational and Behavioral Management Program (EBMP)
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.
Drug: Intervention
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.
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.
1. Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)
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.
Time frame: 12 weeks after intervention initiation
2. Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores
Serial PUF assessment (total score range: 0-40; higher scores indicate more severe pelvic urinary symptoms) to track symptom severity alterations.
Time frame: Time Frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICSI score
Score range 0-20, evaluating urinary symptoms including frequency, nocturia, urgency and pain
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Incidence and Severity Grading of Adverse Events
All adverse events throughout follow-up will be collected and graded as mild, moderate, severe, or life-threatening for safety evaluation
Time frame: Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICPI score
Score range 0-16, assessing distress triggered by urinary symptoms Unit of measure: Scale score
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
No study locations are listed for this record.
Plan to share: Undecided — Decisions on individual participant data (IPD) sharing have not been finalized at the current trial registration stage. The research team will assess institutional data policies, patient privacy constraints, and future collaborative demands later during the trial. Any formal data-sharing arrangements will be updated promptly on ClinicalTrials.gov once confirmed.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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