Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04807569
Other study ID # 2/2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04721210 - The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain N/A