[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650727":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":30,"locations":24,"responsibleParty":36,"collaborators":24,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":24,"enrollmentInfo":50,"targetDuration":24,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":24,"overallStatus":61,"whyStopped":24,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":24},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm1: EBMP Only Group","Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention",[12],"Behavioral: Educational and Behavioral Management Program (EBMP)",{"label":14,"type":15,"description":10,"interventionNames":16},"Arm2: EBMP Plus Pregabalin Group","EXPERIMENTAL",[17],"Drug: Pregabalin",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","Educational and Behavioral Management Program (EBMP)","Standardized educational and behavioral intervention for IC\u002FBPS 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.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Pregabalin","Flexible oral dose titration scheme. Initial daily dosage is 150 mg split into 2-3 administrations. Dosage can be raised to 300 mg\u002Fday 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.",[14],[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Fang Luo doctor","CONTACT","+8615560392365","Litypacop@163.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Fang Luo","doctor","100650727","phase-1-efficacy-and-safety-of-pregabalin-combined-with-educational-and-behavioral-intervention-for-bladder-pain-syndromeinterstitial-cystitis-100650727",false,"NCT07752134","Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladder Pain Syndrome\u002FInterstitial Cystitis","A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention Program for Bladder Pain Syndrome\u002FInterstitial Cystitis","PEBI-ICBPS","Inclusion Criteria:- Adults aged 18 years and older\n\n* Clinically diagnosed with bladder pain syndrome\u002Finterstitial cystitis (IC\u002FBPS) in accordance with diagnostic criteria released by AUA and ESSIC, with confounding disorders excluded through clinical workup\n* Persistent urinary symptoms across most days in the latest 3 months prior to enrollment\n* Participants report bladder pain\u002Fdiscomfort and urinary urgency\u002Ffrequency scores ≥ 3 on the 0-10 Likert scale over the past 4 weeks\n\nExclusion Criteria:- Symptomatic urethral stricture\n\n* Active neurological diseases that impair bladder or intestinal function\n* Active autoimmune disorders or infectious diseases\n* History of cystitis secondary to tuberculosis, pelvic radiotherapy or pelvic chemotherapy\n* Previous history of non-cutaneous malignant tumors\n* Confirmed severe psychiatric disorders at present, including major depressive disorder, bipolar disorder, schizophrenia and other serious mental illnesses\n* Severe systemic diseases featuring obvious dysfunction of the heart, lung, liver or kidney\n* Confirmed hypersensitivity to pregabalin\n* Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Pregnancy status\n* Lactation period","ALL","18 Years",{"count":51,"type":52},200,"ESTIMATED","INTERVENTIONAL",[55],"PHASE1","Bladder pain syndrome\u002Finterstitial cystitis (IC\u002FBPS) 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\u002FBPS, 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\u002FBPS patients.\n\nA total of 140 eligible adult participants fulfilling AUA and ESSIC diagnostic criteria for IC\u002FBPS 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.\n\nAll 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\u002FBPS.",[58,27,59,60],"Bladder Pain Syndrome","Educational Behavioral Intervention","Urinary Urgency","NOT_YET_RECRUITING","2026-08-06",{"date":64,"type":65},"2026-08-07","ACTUAL",{"date":67,"type":52},"2026-12-31",{"date":69,"type":52},"2027-12-31",{"name":5,"class":6}]