"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"

Not Applicable

• Conditions: Overactive Bladder
• Interventions: Device: Transvertebral magnetic stimulation

• Registration Number: NCT04578899
• Lead Sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation

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.

Study Timeline

• Study Start: 2020-09-04
• Study First Submitted: 2020-09-15
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-03-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvertebral magnetic stimulation (Experimental group)	Transvertebral magnetic stimulation	Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3).
Transvertebral magnetic stimulation (Control group)	Transvertebral magnetic stimulation	Control group will receive an equivalent number of "stimulation" sessions using the placebo option.

Primary Outcome Measures

Name	Time	Method
Change baseline of micturition episodes per day	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 Outcome Measures

Name	Time	Method
OAB-Q SF Change Score	Baseline, 4, 12, 24, 48 weeks	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.
PGI-I Change Score	Baseline, 4, 12, 24, 48 weeks	Treatment success at 4,12,24,48 weeks after initiation of transvertebral magnetic neuromodulation therapy. Treatment success will be defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I), which is a single item questionnaire that asks respondents to rate their improvement after undergoing treatment on a 7-point Likert scale ranging from "very much worse" to "very much better." Statistical analysis will be by intention-to-treat for the primary outcome. A chi-square test will be utilized to determine if there is a statistically significant difference between the two cohorts and sensitivity analyses will be performed using logistic regression analysis.

Trial Locations

Locations (1)

Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"; 🇷🇺 Saint-Petersburg, Russian Federation