A Phase 1 interventional study of Educational and Behavioral Management Program (EBMP) and Pregabalin in Bladder Pain Syndrome, Pregabalin and Educational Behavioral Intervention, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Beijing Tiantan Hospital · Phase 1, Interventional, and Treatment
Bladder pain syndrome/interstitial cystitis (IC/BPS) brings long-term pelvic pain, frequent urination and poor sleep quality, which severely lowers patients' daily life quality. Educational and behavioral management program (EBMP) is a mainstream non-drug treatment for IC/BPS, yet a considerable proportion of patients fail to achieve satisfying symptom relief via EBMP alone. This multicenter randomized controlled trial aims to compare the efficacy and safety of pregabalin combined with EBMP versus EBMP monotherapy in adult IC/BPS patients.
A total of 140 eligible adult participants fulfilling AUA and ESSIC diagnostic criteria for IC/BPS will be randomized at a 1:1 ratio into two groups. The control group receives standalone EBMP intervention, while the intervention group obtains EBMP plus pregabalin with flexible dosage titration. Pregabalin starts at 150 mg per day, and doses can be gradually adjusted up to a maximum daily limit of 600 mg according to patients' tolerance and symptom improvement during the 12-week intervention period.
All enrolled participants will complete standardized symptom questionnaires, pain scoring and voiding diary assessments at predefined follow-up time points. The primary outcome is treatment response measured by Global Response Assessment (GRA) after 12 weeks of intervention. Secondary evaluations cover VAS pain scores, PUF, ICSI, ICPI scales, bladder functional parameters, quality of life, sleep status and depressive symptoms. Researchers will track all adverse events throughout follow-up to judge the safety of combined treatment. Findings from this trial can offer optimized treatment options for adults diagnosed with IC/BPS.
This prospective multicenter parallel randomized controlled trial adopts both intention-to-treat and per-protocol statistical analyses to compare combined pregabalin plus educational-behavioral intervention against behavioral intervention alone for IC/BPS management. Sample size calculation was performed via PASS 11 software. With the presumed 45% response rate of standalone EBMP and an expected 70% response rate in the combined-treatment arm, bilateral α=0.05 and statistical power of 80% were set for calculation. Allowing for a 10% participant dropout rate, the final planned enrollment is 70 subjects per group (140 participants in total).
Random allocation is conducted through the sealedenvelope.com online platform, with allocation concealment realized by sealed opaque envelopes managed by an independent research assistant who is isolated from data collection and direct patient contact. The trial uses an open-label design for both treating clinicians and participants, while outcome assessors remain blinded to group allocation to reduce evaluation bias.
Eligible adults must meet formal AUA and ESSIC IC/BPS diagnostic benchmarks, with urinary symptoms persisting across most days in the latest 3 months and baseline bladder discomfort scores no lower than 3 on the 0-10 Likert scale. Patients satisfying predefined exclusion criteria such as neurogenic bladder dysfunction, severe uncontrolled systemic diseases, pregabalin hypersensitivity, pregnancy and lactation will not be enrolled.
For the combined-treatment arm, pregabalin titration strictly follows the preset dose-escalation protocol. Once intolerable adverse reactions emerge, dosage will be rolled back to the maximum tolerable dose that is maintained until the 12-week endpoint. SPSS 25.0 will be utilized for subsequent statistical analyses. Normal continuous variables will be expressed as mean ± standard deviation, non-normal metrics will be presented with median and interquartile ranges, and appropriate parametric or non-parametric statistical tests as well as chi-square/Fisher's tests will be selected in line with data distribution features, with statistical significance set at P \< 0.05. Rigorous source-data monitoring will be implemented across all involved medical centers throughout the whole trial course.
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.
Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention
Behavioral: Educational and Behavioral Management Program (EBMP)
Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention
Drug: Pregabalin
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.
Flexible oral dose titration scheme. Initial daily dosage is 150 mg split into 2-3 administrations. Dosage can be raised to 300 mg/day after 3-7 days, then further escalated by 150 mg every 3-7 days based on patient tolerance and symptom relief. The maximum daily dosage is capped at 600 mg. Dosage will be down-titrated to the maximum tolerated dose once intolerable adverse events occur, with stable dosing maintained until Week 12. This medication is only administered to the combined-treatment arm.
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
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: 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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Studies of the drug tested here: Pregabalin