NCT06123364

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

3.5 years

First QC Date

October 29, 2023

Last Update Submit

November 8, 2023

Conditions

Overactive BladderOveractive Bladder Syndrome

Keywords

overactive bladderurinary urge incontinencemirabegronmagnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Incontinence Quality of Life Questionnaire (I-QOL) Score

    From enrollment to the end of treatment at 8 weeks

  • Change in Incontinence Impact Questionnaire - short form (IIQ-7) Score

    From enrollment to the end of treatment at 8 weeks

  • Change in Urogenital Distress Inventory - short form (UDI-6) Score

    From enrollment to the end of treatment at 8 weeks

  • Change in Patient Perception of Intensity of Urgency Scale (PPIUS)

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Active treatment arm

ACTIVE COMPARATOR

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 dailyDevice: Extracorporeal magnetic innervation (active treatment)

Sham treatment arm

SHAM COMPARATOR

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 dailyDevice: Extracorporeal magnetic innervation (sham treatment)

Interventions

mirabegron 50 mg dailyDRUG

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.

Active treatment armSham treatment arm
Extracorporeal magnetic innervation (active treatment)DEVICE

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.

Active treatment arm
Extracorporeal magnetic innervation (sham treatment)DEVICE

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.

Sham treatment arm

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients
  • Age between 30 and 80 years
  • Signs of OAB (including urinary frequency, urgency and urinary urgency incontinence)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Igor But, MD, PhD

    University Medical Centre Maribor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized into 2 study groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive placebo stimulation.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor, MD, PhD

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 8, 2023

Study Start

October 14, 2019

Primary Completion

April 3, 2023

Study Completion

October 1, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

SL(1)