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Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladder Pain Syndrome/Interstitial Cystitis
Sponsor: Beijing Tiantan Hospital
Summary
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.
Official title: A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention Program for Bladder Pain Syndrome/Interstitial Cystitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-12-31
Completion Date
2027-12-31
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
Educational and Behavioral Management Program (EBMP)
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.
Pregabalin
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.