The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity

Study Overview
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Brief Summary
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The main hypothesis of this study is that magnetic neuromodulation can be used to correct bladder overactivity. The investigators assume that the transvertebral magnetic stimulation can improve both the subjective state of patients evaluated through questionnaires and objective parameters evaluated through invasive and non-invasive urodynamic studies. This study will compare two protocols for magnetic stimulation of the sacral spine roots (S2-S3 segments). The investigators propose to find out the dependence of the therapeutic effect on the frequency of stimulation, the frequency of procedures and the duration of the treatment course.

Detailed Description
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The aim of the study is to test the hypothesis that the use of magnetic stimulation of the sacral spine roots (S2 - S3) in patients with idiopathic overactive bladder (OAB) will help reduce the clinical and urodynamic manifestations of bladder overactivity.

Official Title
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A Prospective Multicenter Randomized Blind Placebo-controlled Trial The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Transvertebral magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; Signed informed consent; The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence; The presence of detrusor overactivity patterns based on the results of the urodynamic study (UDI) 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; Pregnancy or suspicion on it; 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.) Pelvic organ prolapse (II-IV stages according to the POP-Q system) The presence of urinary tract infection The presence of tumors of the pelvic organs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In case of presence/absence of inclusion/exclusion criteria and written informed consent will be obtained, patients will be randomized in a 1:1 ratio according to the list of randomized blocks using a computer generator. Patients will be randomized at the last available moment in order to minimise bias.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transvertebral magnetic stimulation (Experimental group)<br>Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3). | Device: Transvertebral magnetic stimulation<br>* Continuous theta-burst with a frequency of 5 Hz, lasting 20 minutes 3 times a week for 5 weeks, the total number of procedures is 15<br>|
| Placebo Comparator: Transvertebral magnetic stimulation (Control group)<br>Control group will receive an equivalent number of stimulation sessions using the placebo option. | Device: Transvertebral magnetic stimulation<br>* Continuous theta-burst with a frequency of 5 Hz, lasting 20 minutes 3 times a week for 5 weeks, the total number of procedures is 15<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4, 12, 24, 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB-Q SF Change Score | Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between the two cohorts by student's t-test. The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life, and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during transvertebral magnetic neuromodulation therapy. The OAB-q SF questionnaire consists of 19 items divided into a 6-item symptom severity (SS) scale and a 13-item health-related quality of life (HRQL) scale, with both scales ranging from 0 to 100. For the OAB-q SS scale a higher score indicates worse symptom severity while for the OAB-q HRQL scale a higher score indicates better quality of life. | Baseline, 4, 12, 24, 48 weeks | 
| PGI-I Change Score | Treatment success at 4,12,24,48 weeks after initiation of transvertebral magnetic neuromodulation therapy. Treatment success will be defined as a response of very much better or much better on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from very much worse to very much better. Statistical analysis will be by intention-to-treat for the primary outcome. A chi-square test will be utilized to determine if there is a statistically significant difference between the two cohorts and sensitivity analyses will be performed using logistic regression analysis. | Baseline, 4, 12, 24, 48 weeks |