Back to resultsThe Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms
Primary Purpose
Bladder Hypersensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Peripheral magnetic neuromodulation
Taking drug Tamsulosin
Sponsored by
About this trial
This is an interventional other trial for Bladder Hypersensitivity
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years;
- Signed informed consent;
- The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.
Exclusion Criteria:
- 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;
Sites / Locations
- Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental group
Control group
Arm 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".
one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04807569
First Posted
March 17, 2021
Last Updated
March 17, 2021
Sponsor
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT04807569
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Hypersensitivity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm 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".
Arm Title
Control group
Arm Type
Experimental
Arm Description
one-month course of drug therapy with alpha-1-adrenoblocker according to the standard scheme
Intervention Type
Other
Intervention Name(s)
Peripheral magnetic neuromodulation
Intervention Description
Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: "pelvic floor rehabilitation
Intervention Type
Drug
Intervention Name(s)
Taking drug Tamsulosin
Intervention Description
Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.
Primary Outcome Measure Information:
Title
IPSS change score
Description
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.
Time Frame
Baseline, 4, 12, 24, 48 weeks
Title
Change baseline of micturition episodes per day
Description
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.
Time Frame
Baseline, 4, 12, 24, 48 weeks
Secondary Outcome Measure Information:
Title
Change baseline of micturition episodes per day
Description
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.
Time Frame
Baseline, 4, 12, 24, 48 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years;
Signed informed consent;
The presence of lower urinary tract symptoms: urinary frequency, nocturia, urgency; feeling of incomplete bladder, weak urine stream.
Exclusion Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gleb Kovalev, MD
Phone
+78126004712
Email
kovalev2207@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitriy Shkarupa, Phd
Phone
+78126004712
Email
shkarupa.dmitry@mail.ru
Facility Information:
Facility Name
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
City
Saint-Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effectiveness of Peripheral Magnetic Stimulation in Men With Lower Urinary Tract Symptoms
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