Bladder Pain SyndromePhase 1PEBI-ICBPSNCT07752134
Efficacy and Safety of Pregabalin Combined With Educational and Behavioral Intervention for Bladder Pain Syndrome/Interstitial Cystitis
A Phase 1 study testing Educational and Behavioral Management Program (EBMP) and Pregabalin in people with Bladder Pain Syndrome and Pregabalin, run by Beijing Tiantan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Pain Syndrome, Pregabalin, Educational Behavioral Intervention
- What is being tested?
- Educational and Behavioral Management Program (EBMP) and Pregabalin
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Confirmed hypersensitivity to pregabalin
- Concomitant use of additional antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs)
- Pregnancy status
- Lactation period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
This prospective multicenter parallel randomized controlled trial adopts both intention-to-treat and per-protocol statistical analyses to compare combined pregabalin plus educational-behavioral intervention against behavioral intervention alone for IC/BPS management. Sample size calculation was performed via PASS 11 software. With the presumed 45% response rate of standalone EBMP and an expected 70% response rate in the combined-treatment arm, bilateral α=0.05 and statistical power of 80% were set for calculation. Allowing for a 10% participant dropout rate, the final planned enrollment is 70 subjects per group (140 participants in total).
Random allocation is conducted through the sealedenvelope.com online platform, with allocation concealment realized by sealed opaque envelopes managed by an independent research assistant who is isolated from data collection and direct patient contact. The trial uses an open-label design for both treating clinicians and participants, while outcome assessors remain blinded to group allocation to reduce evaluation bias.
Eligible adults must meet formal AUA and ESSIC IC/BPS diagnostic benchmarks, with urinary symptoms persisting across most days in the latest 3 months and baseline bladder discomfort scores no lower than 3 on the 0-10 Likert scale. Patients satisfying predefined exclusion criteria such as neurogenic bladder dysfunction, severe uncontrolled systemic diseases, pregabalin hypersensitivity, pregnancy and lactation will not be enrolled.
For the combined-treatment arm, pregabalin titration strictly follows the preset dose-escalation protocol. Once intolerable adverse reactions emerge, dosage will be rolled back to the maximum tolerable dose that is maintained until the 12-week endpoint. SPSS 25.0 will be utilized for subsequent statistical analyses. Normal continuous variables will be expressed as mean ± standard deviation, non-normal metrics will be presented with median and interquartile ranges, and appropriate parametric or non-parametric statistical tests as well as chi-square/Fisher's tests will be selected in line with data distribution features, with statistical significance set at P < 0.05. Rigorous source-data monitoring will be implemented across all involved medical centers throughout the whole trial course.
- Being tested
- Educational and Behavioral Management Program (EBMP), Pregabalin
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational and Behavioral Management Program (EBMP)Behavioural
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.
PregabalinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: EBMP Only Group | Other | Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention Receives: 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 Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after intervention initiation
Secondary outcomes (4)
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.
Measured: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICSI score
Score range 0-20, evaluating urinary symptoms including frequency, nocturia, urgency and pain
Measured: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
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
Measured: Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICPI score
Score range 0-16, assessing distress triggered by urinary symptoms Unit of measure: Scale score
Measured: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752134
- Sponsor's protocol ID
- 2026YJSKTPG-2
- Acronym
- PEBI-ICBPS
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decisions on individual participant data (IPD) sharing have not been finalized at the current trial registration stage. The research team will assess institutional data policies, patient privacy constraints, and future collaborative demands later during the trial. Any formal data-sharing arrangements will be updated promptly on ClinicalTrials.gov once confirmed.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07752134
- Acronym / sponsor ID
- PEBI-ICBPS / 2026YJSKTPG-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective multicenter parallel randomized controlled trial adopts both intention-to-treat and per-protocol statistical analyses to compare combined pregabalin plus educational-behavioral intervention against behavioral intervention alone for IC/BPS management. Sample size calculation was performed via PASS 11 software. With the presumed 45% response rate of standalone EBMP and an expected 70% response rate in the combined-treatment arm, bilateral α=0.05 and statistical power of 80% were set for calculation. Allowing for a 10% participant dropout rate, the final planned enrollment is 70 subjects per group (140 participants in total).
Random allocation is conducted through the sealedenvelope.com online platform, with allocation concealment realized by sealed opaque envelopes managed by an independent research assistant who is isolated from data collection and direct patient contact. The trial uses an open-label design for both treating clinicians and participants, while outcome assessors remain blinded to group allocation to reduce evaluation bias.
Eligible adults must meet formal AUA and ESSIC IC/BPS diagnostic benchmarks, with urinary symptoms persisting across most days in the latest 3 months and baseline bladder discomfort scores no lower than 3 on the 0-10 Likert scale. Patients satisfying predefined exclusion criteria such as neurogenic bladder dysfunction, severe uncontrolled systemic diseases, pregabalin hypersensitivity, pregnancy and lactation will not be enrolled.
For the combined-treatment arm, pregabalin titration strictly follows the preset dose-escalation protocol. Once intolerable adverse reactions emerge, dosage will be rolled back to the maximum tolerable dose that is maintained until the 12-week endpoint. SPSS 25.0 will be utilized for subsequent statistical analyses. Normal continuous variables will be expressed as mean ± standard deviation, non-normal metrics will be presented with median and interquartile ranges, and appropriate parametric or non-parametric statistical tests as well as chi-square/Fisher's tests will be selected in line with data distribution features, with statistical significance set at P < 0.05. Rigorous source-data monitoring will be implemented across all involved medical centers throughout the whole trial course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1: EBMP Only Group | Other | Behavioral: Educational and Behavioral Management Program (EBMP)Drug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention |
| Arm2: EBMP Plus Pregabalin Group | Experimental | Drug: PregabalinDrug: Pregabalin with flexible titration (starting dose 150mg daily, maximal capped daily dose 600mg) + identical EBMP intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Arm1: EBMP Only Group |
| PregabalinFlexible 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. | Drug | Arm2: EBMP Plus Pregabalin Group |
Primary outcome
Proportion of Treatment Responders Assessed by Global Response Assessment (GRA)
Time frame: 12 weeks after intervention initiation
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.
4 secondary outcomes
Changes in Pelvic Pain and Urgency/Frequency (PUF) Scale Scores
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICSI score
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Incidence and Severity Grading of Adverse Events
Time frame: Entire study period with assessments at Day 0, Week 1, Week 3, Week 5, Week 6, Week 12
Changes in ICPI score
Time frame: Baseline (Day 0), Week 1, Week 3, Week 5, Week 6, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Undecided. Decisions on individual participant data (IPD) sharing have not been finalized at the current trial registration stage. The research team will assess institutional data policies, patient privacy constraints, and future collaborative demands later during the trial. Any formal data-sharing arrangements will be updated promptly on ClinicalTrials.gov once confirmed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Educational and Behavioral Management Program (EBMP) and Pregabalin in people with Bladder Pain Syndrome and Pregabalin, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo doctor (+8615560392365, Litypacop@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Treatment Responders Assessed by Global Response Assessment (GRA) (time frame: 12 weeks after intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.