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

NCT04807569 | Unknown

• 1 other identifier: 2/2021
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change baseline of micturition episodes per day

  Baseline, 4, 12, 24, 48 weeks

Study Arms (2)

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".

Other: Peripheral magnetic neuromodulation

Control group

EXPERIMENTAL

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

Drug: Taking drug Tamsulosin

Interventions

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

Experimental group

Taking drug Tamsulosin DRUG

Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.

Control group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Signed informed consent;
• The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"

Saint Petersburg, 196158, Russia

Location

Central Study Contacts

Gleb Kovalev, MD

CONTACT

+78126004712; kovalev2207@gmail.com

Dmitriy Shkarupa, Phd

CONTACT

+78126004712; shkarupa.dmitry@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)