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

Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation

Status: Unknown

Conditions: Overactive Bladder

Treatments: Device: Transvertebral magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04578899

1/2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Transvertebral magnetic stimulation (Experimental group)

Active Comparator group

Description:

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

Treatment:

Device: Transvertebral magnetic stimulation

Transvertebral magnetic stimulation (Control group)

Placebo Comparator group

Description:

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

Treatment:

Device: Transvertebral magnetic stimulation