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

A Prospective Multicenter Randomized Blind Placebo-controlled Trial "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"

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.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Transvertebral magnetic stimulation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anastasia Zaytseva, MD; Phone Number: +79112953055; Email: zaytseva-anast@mail.ru

Study Locations

• Russian Federation
  • Saint-Petersburg, Russian Federation, 196158
    • Recruiting
    • Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
    • Contact: Aleksey Shmelev, MD; Phone Number: +78126004712; Email: aludm2@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transvertebral magnetic stimulation (Experimental group); Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3).	Device: Transvertebral magnetic stimulation; Continuous theta-burst with a frequency of 5 Hz, lasting 20 minutes 3 times a week for 5 weeks, the total number of procedures is 15
Placebo Comparator: Transvertebral magnetic stimulation (Control group); Control group will receive an equivalent number of "stimulation" sessions using the placebo option.	Device: Transvertebral magnetic stimulation; Continuous theta-burst with a frequency of 5 Hz, lasting 20 minutes 3 times a week for 5 weeks, the total number of procedures is 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4, 12, 24, 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4, 12, 24, 48 weeks
PGI-I Change Score	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.	Baseline, 4, 12, 24, 48 weeks

Collaborators and Investigators

• Sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
• Investigators: Principal Investigator: Dmitriy Shkarupa, Phd, JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: 1/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No