Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladd… (NCT07752134) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladder Pain Syndrome/Interstitial Cystitis
200 participantsStarted 2026-12-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:- 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
Exclusion Criteria:- 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)