Clinical trial NCT04721210: The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain
Official title: A Prospective Randomized, Blind, Placebo-controlled Trial "The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Hypersensitivity
Lead sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: VAPS change score
timeFrame: Baseline, 4, 12, 24, 48 weeks
measure: OAB-Q SF change score
timeFrame: Baseline, 4, 12, 24, 48 weeks
measure: Hospital Anxiety and Depression Scale change score
timeFrame: Baseline, 4, 12, 24, 48 weeks
measure: Change baseline of micturition episodes per day
timeFrame: Baseline, 4, 12, 24, 48 weeks
Secondary outcomes:
measure: Improvement of urodynamic parameters
timeFrame: Baseline, 4, 12, 24, 48 weeks
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
Study officials:
References: