The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms

Study Overview
=================
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 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.

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 symptoms and improve the quality of life of patients.

Official Title
-----------------
A Prospective Randomized Trial The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms

Conditions
-----------------
Bladder Hypersensitivity

Intervention / Treatment
-----------------
* Other: Peripheral magnetic neuromodulation
* Drug: Taking drug Tamsulosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>10 sessions of non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: pelvic floor rehabilitation. | Other: Peripheral magnetic neuromodulation<br>* Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: pelvic floor rehabilitation<br>|
| Experimental: Control group<br>one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme | Drug: Taking drug Tamsulosin<br>* Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline, 4, 12, 24, 48 weeks |