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

Bladder Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04807569
• Other study ID #: 2/2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2021
• Source: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
• Contact: Gleb Kovalev, MD
• Phone: +78126004712
• Email: kovalev2207[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Bladder Hypersensitivity
• Hypersensitivity
• Lower Urinary Tract Symptoms

Intervention

Other:
• Peripheral magnetic neuromodulation
Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation

Drug:
• Taking drug Tamsulosin
Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.

Locations

Country	Name	City	State
Russian Federation	Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"	Saint-Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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