"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2021-10-01

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.

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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).

Study Groups

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Transvertebral magnetic stimulation (Experimental group)

Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3).

Group Type ACTIVE_COMPARATOR

Transvertebral magnetic stimulation

Intervention Type 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

Transvertebral magnetic stimulation (Control group)

Control group will receive an equivalent number of "stimulation" sessions using the placebo option.

Group Type PLACEBO_COMPARATOR

Transvertebral magnetic stimulation

Intervention Type 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

Interventions

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Transvertebral magnetic stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years;
2. Signed informed consent;
3. The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence;
4. The presence of detrusor overactivity patterns based on the results of the urodynamic study (UDI)

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. Pregnancy or suspicion on it;
5. 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.)
6. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
7. Pelvic organ prolapse (II-IV stages according to the POP-Q system)
8. The presence of urinary tract infection
9. The presence of tumors of the pelvic organs

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No