Back to resultsThe Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain
Primary Purpose
Bladder Hypersensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional other trial for Bladder Hypersensitivity
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years;
- Signed informed consent;
- The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence; discomfort during filling the bladder, pain in the projection of the bladder over the womb.
- Resistance to standard therapy for bladder hypersensitivity and bladder pain.
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.)
- A history of injuries associated with impaired conduction along the pathways of the brain and spinal cord;
- The presence of detrusor hyperactivity patterns according to the preliminary multichannel urodynamic study;
- The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
- The postvoid residual volume (more than 100 ml);
- The presence of urinary tract infection;
- A history of cancer;
Sites / Locations
- Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Frequency of 1 Hz
Frequency of 10 Hz
Continuous stimulation placebo
Arm Description
continuous stimulation with a frequency of 1 Hz, 2000 pulses, 10 days-daily;
continuous stimulation with a frequency of 10 Hz-10 seconds with a pause of 50 seconds, 2000 pulses, 10 days-daily;
continuous stimulation placebo
Outcomes
Primary Outcome Measures
VAPS change score
VAPS is a continuous scale in the form of a horizontal or 10 cm (100 mm) long and located on it with two extreme points "no pain" and "the strongest pain that can be imagined
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.
Hospital Anxiety and Depression Scale change score
The Hospital Anxiety and Depression Scale (HADS) consists of 14 questions: 7 questions assessing anxiety and 7 questions assessing the presence of depression.
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
Improvement of urodynamic parameters
Secondary endpoints were evaluated using invasive and non-invasive urodynamic studies: uroflowmetry, filling cystometry, and pressure/flow studies. Invasive urodynamic studies will be performed using a transurethral catheter with 3 lumen transurethral catheter in the bladder and a balloon catheter installed in the vagina or rectum to measure abdominal pressure. The rate of filling the bladder is 30 ml/min in the patient's sitting position on the uroflowmetric chair.
Full Information
NCT ID
NCT04721210
First Posted
January 13, 2021
Last Updated
March 17, 2021
Sponsor
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
1. Study Identification
Unique Protocol Identification Number
NCT04721210
Brief Title
The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain
Official Title
A Prospective Randomized, Blind, Placebo-controlled Trial "The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
January 20, 2022 (Anticipated)
Study Completion Date
January 20, 2022 (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 transcranial magnetic neuromodulation can correct the symptoms of hypersensitivity and bladder pain. The investigators assume that under the influence of transcranial magnetic stimulation, both the subjective state of patients assessed by standardized questionnaires and the objective parameters assessed by invasive and non-invasive urodynamic studies will be improved. In this study, two protocols for magnetic stimulation of the supplementary motor area (SMA) will be compared with each other and with placebo. The investigators expect to determine the dependence of the therapeutic effect on the applied stimulation protocol.
Detailed Description
The aim of the study is to test the hypothesis that the use of the magnetic stimulation method SMA in patients with symptoms of bladder hypersensitivity and bladder pain will help to reduce the clinical and urodynamic signs of these pathological conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Hypersensitivity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Frequency of 1 Hz
Arm Type
Experimental
Arm Description
continuous stimulation with a frequency of 1 Hz, 2000 pulses, 10 days-daily;
Arm Title
Frequency of 10 Hz
Arm Type
Experimental
Arm Description
continuous stimulation with a frequency of 10 Hz-10 seconds with a pause of 50 seconds, 2000 pulses, 10 days-daily;
Arm Title
Continuous stimulation placebo
Arm Type
Placebo Comparator
Arm Description
continuous stimulation placebo
Intervention Type
Other
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the "double conical coil" type. Navigation will be carried out through the use of the international system "10-20%". The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv.
Primary Outcome Measure Information:
Title
VAPS change score
Description
VAPS is a continuous scale in the form of a horizontal or 10 cm (100 mm) long and located on it with two extreme points "no pain" and "the strongest pain that can be imagined
Time Frame
Baseline, 4, 12, 24, 48 weeks
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
Hospital Anxiety and Depression Scale change score
Description
The Hospital Anxiety and Depression Scale (HADS) consists of 14 questions: 7 questions assessing anxiety and 7 questions assessing the presence of depression.
Time Frame
Baseline, 4, 12, 24, 48 weeks
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
Baseline, 4, 12, 24, 48 weeks
Secondary Outcome Measure Information:
Title
Improvement of urodynamic parameters
Description
Secondary endpoints were evaluated using invasive and non-invasive urodynamic studies: uroflowmetry, filling cystometry, and pressure/flow studies. Invasive urodynamic studies will be performed using a transurethral catheter with 3 lumen transurethral catheter in the bladder and a balloon catheter installed in the vagina or rectum to measure abdominal pressure. The rate of filling the bladder is 30 ml/min in the patient's sitting position on the uroflowmetric chair.
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; discomfort during filling the bladder, pain in the projection of the bladder over the womb.
Resistance to standard therapy for bladder hypersensitivity and bladder pain.
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.)
A history of injuries associated with impaired conduction along the pathways of the brain and spinal cord;
The presence of detrusor hyperactivity patterns according to the preliminary multichannel urodynamic study;
The presence of infravesical obstruction in men, determined by uroflowmetry (obstructive urination curve according to the Liverpool nomogram);
The postvoid residual volume (more than 100 ml);
The presence of urinary tract infection;
A history of cancer;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gleb Kovalev, MD
Phone
+78126004712
Email
kovalev2207@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitriy Shkarupa, Phd
Email
shkarupa.dmitry@mail.ru
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
Learn more about this trial
The Effectiveness of Transcranial Magnetic Stimulation of Supplementary Motor Area (SMA) in Patients With Bladder Hypersensitivity and Bladder Pain
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