The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain

Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation28 enrolled

Overview

The main hypothesis of this study is that transcranial magnetic neuromodulation can correct the symptoms of hypersensitivity and bladder pain. The investigators assume that under the influence of transcranial magnetic stimulation, both the subjective state of patients assessed by standardized questionnaires and the objective parameters assessed by invasive and non-invasive urodynamic studies will be improved. In this study, two protocols for magnetic stimulation of the supplementary motor area (SMA) will be compared with each other and with placebo. The investigators expect to determine the dependence of the therapeutic effect on the applied stimulation protocol.

The aim of the study is to test the hypothesis that the use of the magnetic stimulation method SMA in patients with symptoms of bladder hypersensitivity and bladder pain will help to reduce the clinical and urodynamic signs of these pathological conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Bladder Hypersensitivity

Interventions

The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the "double conical coil" type. Navigation will be carried out through the use of the international system "10-20%". The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 18 years; 2. Signed informed consent; 3. The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence; discomfort during filling the bladder, pain in the projection of the bladder over the womb. 4. Resistance to standard therapy for bladder hypersensitivity and bladder pain. 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. A history of injuries associated with impaired conduction along the pathways of the brain and spinal cord; 8. The presence of detrusor hyperactivity patterns according to the preliminary multichannel urodynamic study; 9. The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram); 10. The postvoid residual volume (more than 100 ml); 11. The presence of urinary tract infection; 12. A history of cancer;

Outcomes

Primary Outcomes

VAPS change score

VAPS is a continuous scale in the form of a horizontal or 10 cm (100 mm) long and located on it with two extreme points "no pain" and "the strongest pain that can be imagined