Overactive BladderNCT06123364
Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder
A study testing mirabegron 50 mg daily and Extracorporeal magnetic innervation (active treatment) in people with Overactive Bladder and Overactive Bladder Syndrome, run by Serdinsek Tamara at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome
- What is being tested?
- mirabegron 50 mg daily and Extracorporeal magnetic innervation (active treatment)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSlovenia
- Study dates
- 14 Oct 2019to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Age between 30 and 80 years
- Signs of OAB (including urinary frequency, urgency and urinary urgency incontinence)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Being tested
- mirabegron 50 mg daily, Extracorporeal magnetic innervation (active treatment), Extracorporeal magnetic innervation (sham treatment)
- Keywords
- overactive bladder, urinary urge incontinence, mirabegron, magnetic stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: mirabegron 50 mg daily; Device: 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. Receives: Drug: mirabegron 50 mg daily; Device: Extracorporeal magnetic innervation (sham treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start14 Oct 2019
- Primary completion3 Apr 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serdinsek Tamara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serdinsek Tamara, University Medical Centre Maribor
- Investigators
- Igor But, MD, PhD, Study director, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123364
- Sponsor's protocol ID
- IRP-2018/01-06
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Urinary Frequency, Urgency and Urge Incontinence
- ClinicalTrials.gov ID
- NCT06123364
- Acronym / sponsor ID
- IRP-2018/01-06
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Keywords
- overactive bladder, urinary urge incontinence, mirabegron, magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Serdinsek TamaraUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active treatment arm | Active comparator | Drug: mirabegron 50 mg daily, Device: Extracorporeal magnetic innervation (active treatment)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. |
| Sham treatment arm | Sham comparator | Drug: mirabegron 50 mg daily, Device: Extracorporeal magnetic innervation (sham treatment)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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients
- Age between 30 and 80 years
- Signs of OAB (including urinary frequency, urgency and urinary urgency incontinence)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegron 50 mg dailyPatients 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. | Drug | Active treatment arm, Sham treatment arm |
| 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 | Active treatment arm |
| 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. | Device | Sham treatment arm |
Primary outcome
Change in the rate of urgency incontinence episodes
Time frame: From enrollment to the end of treatment at 8 weeks
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.
4 secondary outcomes
Change in Incontinence Quality of Life Questionnaire (I-QOL) Score
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Incontinence Impact Questionnaire - short form (IIQ-7) Score
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Urogenital Distress Inventory - short form (UDI-6) Score
Time frame: From enrollment to the end of treatment at 8 weeks
Change in Patient Perception of Intensity of Urgency Scale (PPIUS)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor But, MD, PhD study director
University Medical Centre Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirabegron 50 mg daily and Extracorporeal magnetic innervation (active treatment) in people with Overactive Bladder and Overactive Bladder Syndrome, run by Serdinsek Tamara at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the rate of urgency incontinence episodes (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.