Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladder Pain Syndrome/Interstitial Cystitis

NCT07752134 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2026YJSKTPG-2
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bladder Pain Syndrome; Pregabalin; Educational Behavioral Intervention; Urinary Urgency

Outcome Measures

Primary Outcomes (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.

  12 weeks after intervention initiation

Secondary Outcomes (4)

• Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores

  Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

• Changes in ICSI score

  Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

• Incidence and Severity Grading of Adverse Events

  Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12

• Changes in ICPI score

  Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12

Study Arms (2)

Arm1: EBMP Only Group

OTHER

Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention

Behavioral: Educational and Behavioral Management Program (EBMP)

Arm2: EBMP Plus Pregabalin Group

EXPERIMENTAL

Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention

Drug: Pregabalin

Interventions

Educational and Behavioral Management Program (EBMP) BEHAVIORAL

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.

Arm1: EBMP Only Group

Pregabalin DRUG

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.

Arm2: EBMP Plus Pregabalin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Previous history of non-cutaneous malignant tumors
• Confirmed severe psychiatric disorders at present, including major depressive disorder, bipolar disorder, schizophrenia and other serious mental illnesses
• Severe systemic diseases featuring obvious dysfunction of the heart, lung, liver or kidney
• Confirmed hypersensitivity to pregabalin
• Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Pregnancy status
• Lactation period

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Fang Luo doctor

CONTACT

+8615560392365; Litypacop@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08