Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder

Summary

The goal of this clinical trial is to learn about impact of extracorporeal electromagnetic stimulation in addition to medical treatment with mirabegron on the treatment of overactive bladder (OAB). The study will include female patients, aged between 30 and 80, with signs of OAB, including urinary frequency, urgency and urinary urgency incontinence.

The main questions it aims to answer are:

* Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the urinary urgency incontinent or frequency?
* Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the urine flow or post-void residual volume?
* Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the patients' quality of life.

Participants will:

* receive 50 mg of mirabegron daily in the form of tablets, which is used to treat OAB according to current treatment guidelines.
* Twice a week receive extracorporeal electromagnetic stimulation in the duration of 20 minutes. The patients will be divided into 2 groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive placebo stimulation.
* Have a urogynecological examination, with ultrasound measurements of the remaining urine in the bladder and determination of the thickness of the bladder wall, as well as a uroflow examination, after 4 and 8 weeks of treatment.
* Have to to submit urine for laboratory tests and to fill out questionnaires regarding participants' symptoms, after 4 and 8 weeks of treatment.

Researchers will compare both study groups to see if the addition of extracorporeal electromagnetic stimulation has influence on the research questions stated above.

Conditions

• Overactive Bladder
• Overactive Bladder Syndrome

Interventions

DRUG

mirabegron 50 mg daily

Patients in both study groups will receive 50 mg of mirabegron daily in the form of tablets, which is used to treat OAB according to current treatment guidelines.

DEVICE

Extracorporeal magnetic innervation (active treatment)

Patients will twice a week receive extracorporeal electromagnetic stimulation in the duration of 20 minutes. Patients will be randomized into 2 study groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive sham stimulation.

DEVICE

Extracorporeal magnetic innervation (sham treatment)

Patients will twice a week receive extracorporeal electromagnetic stimulation in the duration of 20 minutes. Patients will be randomized into 2 study groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive placebo stimulation.

Sponsors & Collaborators

• Serdinsek Tamara

  lead OTHER

Principal Investigators

• Igor But, MD, PhD · University Medical Centre Maribor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-14

Primary Completion

2023-04-03

Completion

2023-10-01

Countries

• Slovenia

Study Locations