Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome

NCT07698626 — Phase 1, Not yet recruiting, 140 participants, Beijing Tiantan Hospital

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A Multicenter, Open-label, Observer-blinded Randomized Controlled Trial Comparing the Efficacy and Safety of Venlafaxine Plus Education and Behavioral Modification Program Versus Education and Behavioral Modification Program Alone in Adults With Interstitial Cystitis/Bladder Pain Syndrome

Registry	NCT07698626, acronym VEN-BPS
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	140 (Estimated)
Sponsor	Beijing Tiantan Hospital (Other)
Conditions	Bladder Pain Syndrome, Chronic Pelvic Nociplastic Pain, Interstitial Cystitis
Interventions	Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP), Education and Behavioral Modification Program (EBMP) only (Drug, behavioral)
Dates	start 2026-12-31 (estimated), primary completion 2027-12-30 (estimated), completion 2027-12-31 (estimated), first posted 2026-07-13, last updated 2026-07-13

-Summary

This study aims to compare two treatment plans for adults with bladder pain syndrome (also called interstitial cystitis), a disease that causes long-lasting bladder pain, frequent urination and urgent need to pee. All participants will receive standardized patient education and behavioral training to relieve urinary discomfort. Half of the participants will only get this behavioral intervention, while the other half will take oral venlafaxine in addition to the same behavioral training for 12 weeks. We will check patients' pain levels, urination frequency, sleep quality, mood and daily life ability at 1, 2, 6 and 12 weeks of treatment. The main goal is to see whether adding venlafaxine can better ease bladder pain and urinary symptoms without obvious side effects. This research will provide safer and more effective treatment suggestions for patients with bladder pain syndrome.

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+Arms and interventions

Arm	Type	Interventions	Description
Arm 1 Control Arm (n=70)	Other	Behavioral: Education and Behavioral Modification Program (EBMP) only	Intervention Name: Education and Behavioral Modification Program (EBMP) Only Intervention Description: Standardized 12-week behavioral intervention including IC/BPS disease education, bladder irritant dietary restriction guidance, timed bladder training, pelvic floor relaxation training, stress and sleep adjustment guidance. No additional oral antidepressants, analgesics or NSAIDs permitted throughout trial. Weekly telephone follow-up for adherence monitoring.
Arm 2 Experimental Arm (n=70)	Experimental	Drug: Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP)	Intervention Name: Venlafaxine + Education and Behavioral Modification Program (EBMP) Intervention Description: Full identical EBMP intervention as control group, plus flexible-dose oral venlafaxine for 12 weeks. Week 1 starting dose: 75mg once daily evening administration; Week3 escalate to 150mg daily if well-tolerated; Week5 maximum titration up to 225mg daily based on individual tolerance and symptom improvement. Dose down-titration allowed for intolerable adverse events to identify individual maximum tolerated dose (MTD), maintained until week12 endpoint. No rescue analgesic, NSAID or other antidepressant allowed during study period. Weekly telephone follow-up to record drug compliance and adverse reactions.

Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP) (Drug): Oral venlafaxine with flexible dose titration for 12 weeks plus standardized EBMP. Initial dose 75mg once daily in week 1, escalate to 150mg daily at week 3, maximum up to 225mg daily based on tolerance and symptom improvement. All participants receive identical disease education, bladder training, dietary guidance and psychological stress management training weekly. No other antidepressants, NSAIDs or rescue analgesics are allowed during the trial.
Education and Behavioral Modification Program (EBMP) only (Behavioral): 12-week standardized behavioral intervention without additional oral drugs, including IC/BPS disease education, bladder irritant dietary restriction, timed bladder training, pelvic floor relaxation training and sleep/stress adjustment guidance. Weekly telephone follow-up to monitor adherence; no antidepressants or analgesics permitted throughout the study period.

+Outcome measures

Primary outcomes

Patient Self-reported Global Response Assessment (GRA) [12 weeks after randomization]: Binary clinical response endpoint, defined as significant overall improvement in bladder pain and urinary symptoms versus minimal/no improvement, completed by participants at the 12-week treatment endpoint.

Secondary outcomes

Mean Visual Analog Scale (VAS) Bladder Pain Score [Baseline, Week 1, Week2, Week6, Week12]: 0-10 Likert scale; higher scores represent more severe bladder/pelvic discomfort.
Pelvic Pain and Urgency/Frequency (PUF) Total Score [Baseline, Week 1, Week2, Week6, Week12]: 8-item scale total score ranging 0-40; higher scores indicate worse pelvic pain and lower urinary tract symptoms.
O'Leary-Sant ICSI + ICPI Composite Symptom Score [Baseline, Week 1, Week2, Week6, Week12]: ICSI (0-20) evaluates frequency, nocturia, urgency and pain; ICPI (0-16) measures symptom-related life interference.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

Age ≥ 18 years (all genders) Confirmed IC/BPS diagnosis fulfilling AUA 2015 and ESSIC standardized diagnostic criteria, ruled out confounding urologic disorders Predominant lower urinary tract symptoms present for most days in the past 3 months Baseline bladder/pelvic pain and urinary frequency score ≥ 3 points on 0-10 Likert scale within prior 4 weeks

Exclusion Criteria:

Symptomatic urethral stricture Active degenerative/inflammatory neurological disease altering bladder/intestinal function Uncontrolled active autoimmune disease or systemic infection Medical history of pelvic tuberculosis, pelvic radiotherapy or chemotherapy-induced cystitis History of non-cutaneous malignant tumors Current diagnosis of severe psychiatric disorders (major depressive disorder, bipolar disorder, schizophrenia, psychotic disorders) Clinically significant moderate-severe cardiac, pulmonary, hepatic or renal insufficiency Documented hypersensitivity to venlafaxine or other SNRI drugs Concurrent regular use of antibiotics or NSAIDs throughout trial period Pregnancy or breastfeeding state at screening