Acupuncture as First-line Therapy for Patients With Interstitial Cystitis/Painful Bladder Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- O'Leary-Sant Interstitial Cystitis Index (OLSICI)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Acupuncture (Other)
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.
干预措施: Behavioral management (Behavioral)
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.
干预措施: Physical therapy (Other)
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.
干预措施: Behavioral management (Behavioral)
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.
干预措施: Physical therapy (Other)
结局指标
主要结局
O'Leary-Sant Interstitial Cystitis Index (OLSICI)
时间窗: 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.
次要结局
- Genitourinary Pain Index (GUPI)(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(1 year post-treatment period)
- Short Form (SF-36)(x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period))
- Patient Global Impression of Improvement (PGI-I)(x1 (end of 6 week study protocol period), x1 (end of 1 year post-treatment period))
- Number of unscheduled interactions(1 year post-treatment period)
研究者
David Sheyn
Physician, UHMG
University Hospitals Cleveland Medical Center