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

Not Applicable

• Conditions: Bladder Hypersensitivity
• Interventions: Other: Peripheral magnetic neuromodulation; Drug: Taking drug Tamsulosin

• Registration Number: NCT04807569
• Lead Sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Study Start: 2021-04-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 68

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Peripheral magnetic neuromodulation	10 sessions of non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation".
Control group	Taking drug Tamsulosin	one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme

Primary Outcome Measures

Name	Time	Method
IPSS change score	Baseline, 4, 12, 24, 48 weeks	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.
Change baseline of micturition episodes per day	Baseline, 4, 12, 24, 48 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change baseline of micturition episodes per day	Baseline, 4, 12, 24, 48 weeks	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.

Trial Locations

Locations (1)

Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"; 🇷🇺 Saint-Petersburg, Russian Federation