Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP), Education and Behavioral Modification Program (EBMP) only.
- Who it may be relevant to
- Registry conditions: Bladder Pain Syndrome, Chronic Pelvic Nociplastic Pain, Interstitial Cystitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP)
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. - Behavioral Education and Behavioral Modification Program (EBMP) only
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.
Primary outcome measures
- Patient Self-reported Global Response Assessment (GRA) [Time frame: 12 weeks after randomization]
Secondary outcome measures (3)
- Mean Visual Analog Scale (VAS) Bladder Pain Score [Time frame: Baseline, Week 1, Week2, Week6, Week12]
- Pelvic Pain and Urgency/Frequency (PUF) Total Score [Time frame: Baseline, Week 1, Week2, Week6, Week12]
- O'Leary-Sant ICSI + ICPI Composite Symptom Score [Time frame: Baseline, Week 1, Week2, Week6, Week12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07698626 · 2026YJSKTPG