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.
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
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
Parallel
Educational and Behavioral Management Program (EBMP)
BehavioralStandardized 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
DrugFlexible 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.
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.
Changes in ICSI score
Score range 0-20, evaluating urinary symptoms including frequency, nocturia, urgency and pain
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
Changes in ICPI score
Score range 0-16, assessing distress triggered by urinary symptoms Unit of measure: Scale score
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
