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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvertebral magnetic stimulation (Experimental group) | Active Comparator | Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3). |
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| Transvertebral magnetic stimulation (Control group) | Placebo Comparator | Control group will receive an equivalent number of "stimulation" sessions using the placebo option. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvertebral magnetic stimulation | Device | 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Zaytseva, MD | Contact | +79112953055 | zaytseva-anast@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Dmitriy Shkarupa, Phd | JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" | Recruiting | Saint Petersburg | 196158 | Russia |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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The hidden distribution of patients will be made with using sequentially numbered sealed opaque envelopes containing the patient's digital code. The randomization code will be recorded in the participant's notes, the patient report form. Then the "sent out" code will be provided to the doctor to prepare a stimulation or placebo.Blinding during the study will be achieved by using a specialized "placebo" function built into the magnetic stimulator "Neuro-MS/d Therapeutic". When using this option, the patient will hear the characteristic sound of the device running, but full pulse stimulation will not be performed. Patients will be deprived of information about the treatment received (stimulation/placebo).
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |