A Prospective Multicenter Randomized Blind Placebo-controlled Trial "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change baseline of micturition episodes per day
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years;
- •Signed informed consent;
- •The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence;
- •The presence of detrusor overactivity patterns based on the results of the urodynamic study (UDI)
Exclusion Criteria
- •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).
- •Convulsive attacks in the anamnesis;
- •Taking medications that may trigger the risk of seizures;
- •Pregnancy or suspicion on it;
- •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.)
- •Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
- •Pelvic organ prolapse (II-IV stages according to the POP-Q system)
- •The presence of urinary tract infection
- •The presence of tumors of the pelvic organs
Outcomes
Primary Outcomes
Change baseline of micturition episodes per day
Time Frame: 4, 12, 24, 48 weeks
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.
Secondary Outcomes
- OAB-Q SF Change Score(Baseline, 4, 12, 24, 48 weeks)
- PGI-I Change Score(Baseline, 4, 12, 24, 48 weeks)