Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder
Condition: Overactive Bladder; Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

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.
    

Detailed description: 
      In this study the investigators are studying the impact of extracorporeal electromagnetic
      stimulation on the treatment of overactive bladder (OAB).

      For the research, the investigators will gather participants' basic demographic information
      (age, co-morbidities, etc.), results of uro-gynecological examinations (gynecological and
      transabdominal ultrasound, uroflow, urinalysis) and the results of different questionnaires,
      which will be filled out by the participants, describing the burden of the investigated
      disease and the impact on quality of life.

      The research will last 8 weeks. Before the start of the research, participants will submit a
      urine sample to rule out a urinary tract infection and determine baseline laboratory
      parameters in the urine. Participants will then 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 participants will come to the Department of General Gynecology and Gynecological
      Urology, Clinic of Gynecology and Perinatology, UMC Maribor, where the investigators will
      additionally perform extracorporeal electromagnetic stimulation for the treatment of OAB.
      These treatments will last 20 minutes each time. The patients will be divided into 2 groups,
      namely one group will receive actual electromagnetic stimulation, and the other group will
      receive placebo stimulation.

      At the beginning of the research and after 4 and 8 weeks, the investigators will perform a
      uro-gynecological 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. It will be necessary for the participants to submit urine for laboratory tests
      and to fill out questionnaires regarding OAB symptoms.

      Based on the safety profile of mirabegron and extracorporeal electromagnetic stimulation, the
      investigators do not expect any serious side effects. The investigators anticipate that there
      will be a reduction in the symptoms caused by the overactive bladder. In the event of a
      serious adverse event, participants can contact the on-call gynecologist or on-call urologist
      at UMC Maribor, who are available 24 hours a day.

      In the research, the participants' personal data will remain undisclosed, as the
      investigators will lead each participant under a random number during data processing, and
      will also display the results in the form of an average for the entire group of participants,
      so that it will not be possible to draw conclusions about participants' identity based on the
      results. Participation in the research is voluntary, and participants can stop participating
      at any stage of the research.
    

Intervention name(s): mirabegron 50 mg daily; Extracorporeal magnetic innervation (active treatment); Extracorporeal magnetic innervation (sham treatment)
Intervention type(s): Drug; Device; Device
Intervention description(s): 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.; 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.; 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.
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into 2 study groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive placebo stimulation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: overactive bladder; urinary urge incontinence; mirabegron; magnetic stimulation