IC/BPS 针灸优先
针灸作为间质性膀胱炎/膀胱疼痛综合征患者的一线治疗
The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:
Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.
Participants will
- complete surveys about their bladder pain symptoms
- make behavioral changes that have been shown to improve bladder pain symptoms
- attend six (6) weekly acupuncture sessions
- attend six (6) weekly physical therapy sessions after finishing acupuncture
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Gabriella Rustia, MD
- 电话号码：216-202-0597
- 邮箱：gabriella.rustia@uhhospitals.org
研究联系人备份
- 姓名：Jessica Abou Zeki
- 电话号码：216-286-0603
- 邮箱：Jessica.AbouZeki@UHhospitals.org
学习地点
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-
Ohio
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Cleveland、Ohio、美国、44106
- 招聘中
- University Hospitals
-
接触：
- Gabriella Rustia, MD
- 电话号码：216-202-0597
- 邮箱：gabriella.rustia@uhhospitals.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Meets American Urologic Association (AUA) criteria for interstitial cystitis/bladder pain syndrome (IC/BPS): "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause"
- Negative urine culture
- Has completed cystoscopic evaluation for IC/BPS
Exclusion Criteria:
- History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)
- History of overactive bladder
- History of bleeding disorder or are currently on chronic anti-coagulation
- Post-void residual >100mL
- Has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (PTNS), sacral neuromodulation, or intradetrusor Botox
- Prior bladder augmentation
- Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
- Currently pregnant (if applicable, based on self-report)
- Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)
- Non-English speaking and reading
学习计划
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Acupuncture
Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain. They will complete six (6) weekly one hour acupuncture sessions followed by pelvic floor physical therapy. |
traditional and electroacupuncture based on American urologic association guidelines pelvic floor with biofeedback |
|
有源比较器：Behavioral Management
Participants will receive instruction (verbal and written) on recommended changes to diet and urinary habits to treat bladder pain for six (6) weeks before starting pelvic floor physical therapy. |
based on American urologic association guidelines pelvic floor with biofeedback |
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 |
|---|---|---|
|
O'Leary-Sant Interstitial Cystitis Index (OLSICI)
大体时间：Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
|
Validated 8-item questionnaire with reported scores ranging 0-37. Higher scores are consistent with worse symptoms. |
Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
大体时间：x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
|
Validated 1-item likert-scale question on a scale from 1 (very much better) to 7 (very much worse). |
x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
|
|
Short Form (SF-36)
大体时间：x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
|
Validated 36-item questionnaire. Higher scores are consistent with worse symptom control. |
x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period)
|
|
Genitourinary Pain Index (GUPI)
大体时间：Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
|
Validated 9-item questionnaire with reported scores ranging 0-45. Higher scores are consistent with worse symptom control. |
Baseline, every 2 weeks x3 (6 week study protocol period), every 4 weeks x 13 (52 week post-treatment period)
|
|
Number of additional treatments used during study period
大体时间：1 year post-treatment period
|
Treatments include pharmacotherapy, intradetrusor botox, neuromodulation, cyclosporine |
1 year post-treatment period
|
|
Number of unscheduled interactions
大体时间：1 year post-treatment period
|
Unscheduled interactions include any phone calls, messages, or unplanned visits |
1 year post-treatment period
|
合作者和调查者
调查人员
- 首席研究员：David Sheyn, MD、University Hospitals Cleveland Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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