Venlafaxine Combined With Education and Behavioral Intervention for Bladder Pain Syndrome (VEN-BPS)
2026年7月7日 更新者：Fang Luo、Beijing Tiantan Hospital
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
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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
140
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fang Luo FL, doctor
- 电话号码：+8615560392365
- 邮箱：Litypacop@163.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Arm 1 Control Arm (n=70)
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.
|
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.
|
|
实验性的：Arm 2 Experimental Arm (n=70)
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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Self-reported Global Response Assessment (GRA)
大体时间：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.
|
12 weeks after randomization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Visual Analog Scale (VAS) Bladder Pain Score
大体时间：Baseline, Week 1, Week2, Week6, Week12
|
0-10 Likert scale; higher scores represent more severe bladder/pelvic discomfort.
|
Baseline, Week 1, Week2, Week6, Week12
|
|
Pelvic Pain and Urgency/Frequency (PUF) Total Score
大体时间：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.
|
Baseline, Week 1, Week2, Week6, Week12
|
|
O'Leary-Sant ICSI + ICPI Composite Symptom Score
大体时间：Baseline, Week 1, Week2, Week6, Week12
|
ICSI (0-20) evaluates frequency, nocturia, urgency and pain; ICPI (0-16) measures symptom-related life interference.
|
Baseline, Week 1, Week2, Week6, Week12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月31日
初级完成 (估计的)
2027年12月30日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年7月7日
首先提交符合 QC 标准的
2026年7月7日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月7日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026YJSKTPG
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.