An interventional study of Transcranial magnetic stimulation in Bladder Hypersensitivity, sponsored by Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation. Status unknown at 1 site in Russian Federation. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation · Not applicable, Interventional, and Other
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 28 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
continuous stimulation with a frequency of 1 Hz, 2000 pulses, 10 days-daily;
Other: Transcranial magnetic stimulation
continuous stimulation with a frequency of 10 Hz-10 seconds with a pause of 50 seconds, 2000 pulses, 10 days-daily;
Other: Transcranial magnetic stimulation
continuous stimulation placebo
Other: Transcranial magnetic stimulation
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.
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
Time frame: Baseline, 4, 12, 24, 48 weeks
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.
Time frame: Baseline, 4, 12, 24, 48 weeks
Hospital Anxiety and Depression Scale change score
The Hospital Anxiety and Depression Scale (HADS) consists of 14 questions: 7 questions assessing anxiety and 7 questions assessing the presence of depression.
Time frame: Baseline, 4, 12, 24, 48 weeks
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.
Time frame: Baseline, 4, 12, 24, 48 weeks
Improvement of urodynamic parameters
Secondary endpoints were evaluated using invasive and non-invasive urodynamic studies: uroflowmetry, filling cystometry, and pressure/flow studies. Invasive urodynamic studies will be performed using a transurethral catheter with 3 lumen transurethral catheter in the bladder and a balloon catheter installed in the vagina or rectum to measure abdominal pressure. The rate of filling the bladder is 30 ml/min in the patient's sitting position on the uroflowmetric chair.
Time frame: Baseline, 4, 12, 24, 48 weeks
Plan to share: No
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Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation