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

NCT04578899 | Unknown

• 1 other identifier: 1/2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• OAB-Q SF Change Score

  Baseline, 4, 12, 24, 48 weeks

• PGI-I Change Score

  Baseline, 4, 12, 24, 48 weeks

Study Arms (2)

Transvertebral magnetic stimulation (Experimental group)

ACTIVE COMPARATOR

Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3).

Device: Transvertebral magnetic stimulation

Transvertebral magnetic stimulation (Control group)

PLACEBO COMPARATOR

Control group will receive an equivalent number of "stimulation" sessions using the placebo option.

Device: Transvertebral magnetic stimulation

Interventions

Transvertebral magnetic stimulation DEVICE

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

Transvertebral magnetic stimulation (Control group); Transvertebral magnetic stimulation (Experimental group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation: lead

Study Sites (1)

Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"

Saint Petersburg, 196158, Russia

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitriy Shkarupa, Phd

  JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Zaytseva, MD

CONTACT

+79112953055; zaytseva-anast@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The hidden distribution of patients will be made with using sequentially numbered sealed opaque envelopes containing the patient's digital code. The randomization code will be recorded in the participant's notes, the patient report form. Then the "sent out" code will be provided to the doctor to prepare a stimulation or placebo.Blinding during the study will be achieved by using a specialized "placebo" function built into the magnetic stimulator "Neuro-MS/d Therapeutic". When using this option, the patient will hear the characteristic sound of the device running, but full pulse stimulation will not be performed. Patients will be deprived of information about the treatment received (stimulation/placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 8, 2020
• Study Start: September 4, 2020
• Primary Completion: March 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)