The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms
NCT ID: NCT04807569
Last Updated: 2021-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2021-04-01
2022-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Experimental group
10 sessions of non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation".
Peripheral magnetic neuromodulation
Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation
Control group
one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme
Taking drug Tamsulosin
Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.
Interventions
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Peripheral magnetic neuromodulation
Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation
Taking drug Tamsulosin
Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent;
3. The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.
Exclusion Criteria
2. Convulsive attacks in the anamnesis;
3. Taking medications that may trigger the risk of seizures;
4. 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.)
5. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
6. The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
7. The postvoid residual volume (more than 50 ml);
8. The concentration of prostate specific antigen (PSA) in the blood is more than 4.0 ng / ml;
9. The presence of urinary tract infection;
10. A history of cancer of the pelvic floor organs;
25 Years
75 Years
MALE
No
Sponsors
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Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
OTHER
Responsible Party
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Locations
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Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
Saint Petersburg, , Russia
Countries
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Central Contacts
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Other Identifiers
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2/2021
Identifier Type: -
Identifier Source: org_study_id
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