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

• Status: Completed
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serdinsek Tamara
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• Female patients

• Age between 30 and 80 years

• Signs of OAB (including urinary frequency, urgency and urinary urgency incontinence)

Exclusion Criteria:

• Positive urine culture

• Treatment with anticholinergics or mirabegron in the last 3 months

• Physiotherapy treatment of the pelvic floor muscles (e.g. pelvic floor exercises, electrical stimulation, etc.) in the last 3 months

• Stress incontinence

• Pelvic malignancies

• Pregnancy

• Cardiac pacemaker, implantable cardiac defibrillator

• Electronic device or metallic implant applied to areas between the lumbar region and lower extremities