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

Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation

Status: Unknown

Conditions: Bladder Hypersensitivity

Treatments: Other: Peripheral magnetic neuromodulation; Drug: Taking drug Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT04807569

2/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: Male

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years;
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

1. 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).
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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Experimental group

Experimental group

Description:

10 sessions of non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation".

Treatment:

Other: Peripheral magnetic neuromodulation

Control group

Experimental group

Description:

one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme

Treatment:

Drug: Taking drug Tamsulosin