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

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

Study Overview

• Status: Withdrawn
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: electroacupncture; Drug: Mirabegron 50 MG [Myrbetriq]

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• - 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EA; Patients undergoing electroacupuncture weekly for 6 weeks for 30 minutes/session.	Other: electroacupncture; Patients will receive electroacupuncture treatment for 30 minutes per weekly session for 6 weeks.
Active Comparator: 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.	Drug: Mirabegron 50 MG [Myrbetriq]; Patients will receive 50 mg of mirabegron daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Incontinence Impact Questionnaire (IIQ-7) scores	change in IIQ-7 scores before and after initiation of treatment	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
Difference in Overactive Bladder Symptom Score (OABSS)	change in OABSS before and after initiation of treatment	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
Urogenital Distress Inventory (UDI-6) scores	change in UDI-6 scores before and after initiation of treatment	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
Differences in daytime frequency	before and after treatment	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
incontinence episodes	change in number of incontinence episodes before and after treatment	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
Nocturia	change in number of nocturia episodes before and after treatment	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence/worsening of symptoms	Recurrence/worsening of symptoms after cessation of acupuncture treatment	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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: overactive bladder, acupuncture
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron
• Other Study ID Numbers: UHClevelandMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No