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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
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.
Patient Self-reported Global Response Assessment (GRA)
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.
Time frame: 12 weeks after randomization
Mean Visual Analog Scale (VAS) Bladder Pain Score
0-10 Likert scale; higher scores represent more severe bladder/pelvic discomfort.
Time frame: Baseline, Week 1, Week2, Week6, Week12
Pelvic Pain and Urgency/Frequency (PUF) Total Score
8-item scale total score ranging 0-40; higher scores indicate worse pelvic pain and lower urinary tract symptoms.
Time frame: Baseline, Week 1, Week2, Week6, Week12
O'Leary-Sant ICSI + ICPI Composite Symptom Score
ICSI (0-20) evaluates frequency, nocturia, urgency and pain; ICPI (0-16) measures symptom-related life interference.
Time frame: Baseline, Week 1, Week2, Week6, Week12
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