Comparison of Electroacupuncture to Mirabegron for Treatment of Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03087578
• Other study ID #: UHClevelandMC
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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