NCT03087578

Comparison of Electroacupuncture to Mirabegron for Treatment of Overactive Bladder

Comparison of Electroacupuncture to Mirabegron on Symptoms of Overactive Bladder in Women Who Have Failed Anti-Cholinergic Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares electroacupuncture to mirabegron for treatment of overactive bladder (OAB) symptoms in women who have failed treatment with anticholingeric therapy.

Detailed description

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: All acupuncture sessions will be performed by a licensed acupuncturist employed by University Hospitals Connor Integrative Health Network. All acupuncturists involved in the study protocol will be trained and supervised in the correct technique by Christine Kaiser, MS, LAc, Dipl.OM. Acupuncture session will be performed weekly for 6 weeks and will be scheduled to accommodate both the patient's and acupuncturists' schedules. Acupuncture sessions will last for 30 minutes. Selected points will include kidney 3, kidney 6, spleen 6, and ren 4. The current delivery with electroacupuncture is approximately 10-20 mA (adjusted to patient sensation) delivery at 10 Hz for 30 minutes per session. After completion of 6 weeks of treatments patients will be contacted by phone at 2 week intervals to determine duration of symptomatic relief after cessation of treatment.. Mirabegron Protocol: Patients assigned to the medication group will be prescribed 50 mg of myrbetriq daily to take for 6 weeks. At the completion of the study, if patients are satisfied with the effect of mirabegron they may continue to use it at their discretion.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
OTHER	electroacupncture	Patients will receive electroacupuncture treatment for 30 minutes per weekly session for 6 weeks.
DRUG	Mirabegron 50 MG [Myrbetriq]	Patients will receive 50 mg of mirabegron daily for 6 weeks.

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-07-01
• Completion: 2018-09-30
• First posted: 2017-03-22
• Last updated: 2022-05-06

Locations

1 site across 1 country: United States