Back to results"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
Primary Purpose
Overactive Bladder
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Transvertebral magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
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
Sites / Locations
- Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Transvertebral magnetic stimulation (Experimental group)
Transvertebral magnetic stimulation (Control group)
Arm Description
Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3).
Control group will receive an equivalent number of "stimulation" sessions using the placebo option.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04578899
First Posted
September 15, 2020
Last Updated
October 1, 2020
Sponsor
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT04578899
Brief Title
"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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
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).
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transvertebral magnetic stimulation (Experimental group)
Arm Type
Active Comparator
Arm Description
Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3).
Arm Title
Transvertebral magnetic stimulation (Control group)
Arm Type
Placebo Comparator
Arm Description
Control group will receive an equivalent number of "stimulation" sessions using the placebo option.
Intervention Type
Device
Intervention Name(s)
Transvertebral magnetic stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change baseline of micturition episodes per day
Description
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.
Time Frame
4, 12, 24, 48 weeks
Secondary Outcome Measure Information:
Title
OAB-Q SF Change Score
Description
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.
Time Frame
Baseline, 4, 12, 24, 48 weeks
Title
PGI-I Change Score
Description
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.
Time Frame
Baseline, 4, 12, 24, 48 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasia Zaytseva, MD
Phone
+79112953055
Email
zaytseva-anast@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitriy Shkarupa, Phd
Organizational Affiliation
JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
City
Saint-Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksey Shmelev, MD
Phone
+78126004712
Email
aludm2@mail.ru
12. IPD Sharing Statement
Plan to Share IPD
No
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"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
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