Comparison of Electroacupuncture to Mirabegron on Symptoms of Overactive Bladder in Women Who Have Failed Anti-Cholinergic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Difference in Incontinence Impact Questionnaire (IIQ-7) scores
研究概览
简要总结
This study compares electroacupuncture to mirabegron for treatment of overactive bladder (OAB) symptoms in women who have failed treatment with anticholingeric therapy.
详细描述
Screening/Eligibility Visit:
If it is determined that a patient with a diagnosis of OAB has failed therapy with at least one anti-cholinergic agent, the potential participant will be screened and eligibility will be confirmed by a study investigator. A signed, IRB-approved informed consent will be obtained.
Randomization:
Randomization will be performed after the patient has agreed to participate and discussed and signed the informed consent form. Patients will be randomized in random blocks of 4, 6 and 8 into either the acupuncture group or mirabegron group. Once patient participation is confirmed, an enveloped marked with the study participant number will be opened by one of the study investigators in front of the patient.
Acupuncture Protocol:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Patients must be 18 years or older as well as willing and able to provide informed consent
- •Patients with documented symptoms of overactive bladder including: urgency, frequency >7 times per day, nocturia, urgency incontinence for at least 6 months
- •Patients who have failed at least one anti-cholinergic medication defined as no change or unsatisfactory improvement in symptom severity after 6 weeks of a daily regimen
排除标准
- •Patients younger than 18 years,
- •Patients unable or unwilling to provide informed consent,
- •Patients who are illiterate,
- •Patients who are non-English speaking or reading,
- •Patients with a current urinary tract infection
- •Patients with a history of interstitial cystitis
- •Patients who have a history of a bleeding disorder
- •Patients who are currently on chronic anti-coagulation
- •Patients who are have taken mirabegron in the past or are currently using it
- •Patients currently undergoing acupuncture treatment for a different condition
- •Patients who are currently undergoing pelvic floor physical therapy
- •Patients who are currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
- •Patients who are currently pregnant
- •Patients with an implanted pacemaker or AICD
- •Patients with a history of uncontrolled or poorly controlled hypertension
研究组 & 干预措施
EA
Patients undergoing electroacupuncture weekly for 6 weeks for 30 minutes/session.
干预措施: electroacupncture (Other)
Medication
Patients will receive 50 mg of mirabegron daily for 6 weeks. Patients may continue to take this medication after the study if they have improvement in symptoms.
干预措施: Mirabegron 50 MG [Myrbetriq] (Drug)
结局指标
主要结局
Difference in Incontinence Impact Questionnaire (IIQ-7) scores
时间窗: at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group
change in IIQ-7 scores before and after initiation of treatment
Difference in Overactive Bladder Symptom Score (OABSS)
时间窗: at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group
change in OABSS before and after initiation of treatment
incontinence episodes
时间窗: at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group
change in number of incontinence episodes before and after treatment
Nocturia
时间窗: at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group
change in number of nocturia episodes before and after treatment
Urogenital Distress Inventory (UDI-6) scores
时间窗: at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group
change in UDI-6 scores before and after initiation of treatment
Differences in daytime frequency
时间窗: at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group
before and after treatment
次要结局
- Recurrence/worsening of symptoms(at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group)