Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06123364 |
Other study ID # |
IRP-2018/01-06 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 14, 2019 |
Est. completion date |
October 1, 2023 |
Study information
Verified date |
November 2023 |
Source |
University Medical Centre Maribor |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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). 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.
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.