Status:
UNKNOWN
The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms
Lead Sponsor:
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
Conditions:
Bladder Hypersensitivity
Eligibility:
MALE
25-75 years
Phase:
NA
Brief Summary
The main hypothesis of this study is that peripheral magnetic neuromodulation can correct the symptoms of lower urinary tract in men. We assume that under the influence of t peripheral magnetic stimul...
Detailed Description
The aim of the study is to test the hypothesis that the use of the peripheral magnetic stimulation in men with lower urinary tract symptoms will help to reduce subjective and objective clinical sympto...
Eligibility Criteria
Inclusion
- Age \> 18 years;
- Signed informed consent;
- The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.
Exclusion
- The patient, who have been implanted devices that control physiological functions (a pacemaker, a device for deep brain stimulation and chronic epidural brain stimulation, a cochlear implant).
- Convulsive attacks in the anamnesis;
- Taking medications that may trigger the risk of seizures;
- The presence in the patient's body of metal elements or objects made with the use of ferromagnets (joint prostheses, eye prostheses, tattoos made using metal ink, surgical clips, staples and other metal suture materials, etc.)
- Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
- The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
- The postvoid residual volume (more than 50 ml);
- The concentration of prostate specific antigen (PSA) in the blood is more than 4.0 ng / ml;
- The presence of urinary tract infection;
- A history of cancer of the pelvic floor organs;
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04807569
Start Date
April 1 2021
End Date
April 1 2022
Last Update
March 19 2021
Active Locations (1)
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1
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
Saint Petersburg, Russia, 196158