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

The Effects of Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Urinary Frequency, Urgency and Urge Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Overactive Bladder Syndrome
• Intervention / Treatment: Drug: mirabegron 50 mg daily; Device: Extracorporeal magnetic innervation (active treatment); Device: Extracorporeal magnetic innervation (sham treatment)

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Maribor, Slovenia, 2000
    • University Medical Centre Maribor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active treatment arm; Patients in this study arm will receive 50 mg of mirabegron daily in the form of tablets, which is used to treat OAB according to current treatment guidelines. Additionally they will twice a week receive an actual extracorporeal electromagnetic stimulation in the duration of 20 minutes, for 8 weeks.	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.
Sham Comparator: Sham treatment arm; Patients in this study arm will receive 50 mg of mirabegron daily in the form of tablets, which is used to treat OAB according to current treatment guidelines. Additionally they will twice a week receive a sham extracorporeal electromagnetic stimulation in the duration of 20 minutes, for 8 weeks.	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 (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the rate of urgency incontinence episodes	The investigators will monitor the rate of urgency incontinence episodes at the enrollment and throughout the study to detect a possible urgency incontinence rate change.	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Incontinence Quality of Life Questionnaire (I-QOL) Score	The investigators will monitor the change in Incontinence Quality of Life Questionnaire (I-QOL) Score at the enrollment and throughout the study to detect a possible improvement in quality of life. The score rage is from values 0 to 100, where higher scores mean a better outcome.	From enrollment to the end of treatment at 8 weeks
Change in Incontinence Impact Questionnaire - short form (IIQ-7) Score	The investigators will monitor the change in Incontinence Impact Questionnaire - short form (IIQ-7) Score at the enrollment and throughout the study to detect a possible improvement in quality of life. The score rage is from values 0 to 100, where lower scores mean a better outcome.	From enrollment to the end of treatment at 8 weeks
Change in Urogenital Distress Inventory - short form (UDI-6) Score	The investigators will monitor the change in Urogenital Distress Inventory - short form (UDI-6) Score at the enrollment and throughout the study to detect a possible improvement in quality of life. The score rage is from values 0 to 100, where lower scores mean a better outcome.	From enrollment to the end of treatment at 8 weeks
Change in Patient Perception of Intensity of Urgency Scale (PPIUS)	The investigators will monitor the change in Patient Perception of Intensity of Urgency Scale (PPIUS) at the enrollment and throughout the study to detect a possible improvement in quality of life. The score rage is from values 0 to 4, where lower scores mean a better outcome.	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Serdinsek Tamara
• Investigators: Study Director: Igor But, MD, PhD, University Medical Centre Maribor

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: overactive bladder; mirabegron; magnetic stimulation; urinary urge incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; 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: IRP-2018/01-06

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