Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP)
DrugOral 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
Behavioral12-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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Arm 1 Control Arm (n=70)Other 1 intervention
Group B: Arm 2 Experimental Arm (n=70)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 randomizationSecondary outcomes
1
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, Week122
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, Week123
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, Week12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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