Clinical trial NCT04578899: "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
Official title: A Prospective Multicenter Randomized Blind Placebo-controlled Trial "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In case of presence/absence of inclusion/exclusion criteria and written informed consent will be obtained, patients will be randomized in a 1:1 ratio according to the list of randomized blocks using a computer generator. Patients will be randomized at the last available moment in order to minimise bias.
Primary purpose: TREATMENT

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.

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;
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

Primary outcomes:
measure: Change baseline of micturition episodes per day
timeFrame: 4, 12, 24, 48 weeks
Secondary outcomes:
measure: OAB-Q SF Change Score
timeFrame: Baseline, 4, 12, 24, 48 weeks
measure: PGI-I Change Score
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:
affiliation: JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE
name: Dmitriy Shkarupa, Phd
role: PRINCIPAL_INVESTIGATOR
References: