A Phase 1 interventional study of Venlafaxine oral tablet combined with Education and Behavioral Modification Program (EBMP) and Education and Behavioral Modification Program (EBMP) only in Bladder Pain Syndrome, Chronic Pelvic Nociplastic Pain and Interstitial Cystitis, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Beijing Tiantan Hospital · Phase 1, Interventional, and Treatment
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.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 140 is above the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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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 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) moderate-severe cardiac, pulmonary, hepatic or renal insufficiency Documented to venlafaxine or other SNRI drugs Concurrent regular use of antibiotics or NSAIDs throughout trial period Pregnancy or breastfeeding state at screening
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Education and Behavioral Modification Program (EBMP) only
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.
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.
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
No study locations are listed for this record.
Plan to share: Undecided — The plan for sharing individual participant data (IPD) has not yet been finalized. After trial completion, the research team will evaluate data sharing feasibility under the supervision of the Institutional Review Board, including assessment of participant privacy protection, data de-identification procedures, institutional data management policies and relevant domestic clinical research data regulations. A formal data sharing plan will be formulated and updated to this registry before study results publication.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 11 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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