Clinical trial NCT04807569: The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms
Official title: A Prospective Randomized Trial "The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Hypersensitivity
Lead sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 68
Sex: MALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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;

Primary outcomes:
measure: IPSS change score
timeFrame: Baseline, 4, 12, 24, 48 weeks
measure: Change baseline of micturition episodes per day
timeFrame: Baseline, 4, 12, 24, 48 weeks
Secondary outcomes:
measure: Change baseline of micturition episodes per day
timeFrame: Baseline, 4, 12, 24, 48 weeks
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
Study officials:
References: