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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 stimulation, both the subjective state of patients assessed by standardized questionnaires and a urination diary, as well as the objective parameters, assessed by non-invasive urodynamic studies, will be improved. This study will use standard protocols built into the BTL Emsella magnetic stimulator.
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 symptoms and improve the quality of life of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 10 sessions of non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation". |
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| Control group | Experimental | one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral magnetic neuromodulation | Other | Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation |
| Measure | Description | Time Frame |
|---|---|---|
| IPSS change score | The IPSS questionnaire evaluates the impact of lower urinary tract symptoms on the patient's quality of life. It consists of 8 questions. Questionts evaluates whether the patient has symptoms of incomplete emptying of the bladder and ranges from 0 to 5 points. The increase in scores is directly proportional to the increase in symptoms. | Baseline, 4, 12, 24, 48 weeks |
| Change baseline of micturition episodes per day | Patients should document how many times they go to the restroom during the day and at night, as well as the loss of urine in stressful situations (coughing, sneezing, laughter, squatting, weightlifting, walking, running), changing liner or absorbent and episodes of urgency and urgency-incontinence. The journal shall be held for a consecutive period of 24 hours, for a minimum of three consecutive days. | Baseline, 4, 12, 24, 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change baseline of micturition episodes per day | Patients should document how many times they go to the restroom during the day and at night, as well as the loss of urine in stressful situations (coughing, sneezing, laughter, squatting, weightlifting, walking, running), changing liner or absorbent and episodes of urgency and urgency-incontinence. The journal shall be held for a consecutive period of 24 hours, for a minimum of three consecutive days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gleb Kovalev, MD | Contact | +78126004712 | kovalev2207@gmail.com | |
| Dmitriy Shkarupa, Phd | Contact | +78126004712 | shkarupa.dmitry@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" | Saint Petersburg | 196158 | Russia |
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| Taking drug Tamsulosin | Drug | Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month. |
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| Baseline, 4, 12, 24, 48 weeks |