NCT04721210

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

January 13, 2021

Last Update Submit

March 17, 2021

Conditions

Bladder Hypersensitivity

Outcome Measures

Primary Outcomes (4)

  • 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

    Baseline, 4, 12, 24, 48 weeks

  • 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

  • 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.

    Baseline, 4, 12, 24, 48 weeks

  • 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.

    Baseline, 4, 12, 24, 48 weeks

Secondary Outcomes (1)

  • Improvement of urodynamic parameters

    Baseline, 4, 12, 24, 48 weeks

Study Arms (3)

Frequency of 1 Hz

EXPERIMENTAL

continuous stimulation with a frequency of 1 Hz, 2000 pulses, 10 days-daily;

Other: Transcranial magnetic stimulation

Frequency of 10 Hz

EXPERIMENTAL

continuous stimulation with a frequency of 10 Hz-10 seconds with a pause of 50 seconds, 2000 pulses, 10 days-daily;

Other: Transcranial magnetic stimulation

Continuous stimulation placebo

PLACEBO COMPARATOR

continuous stimulation placebo

Other: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationOTHER

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.

Continuous stimulation placeboFrequency of 1 HzFrequency of 10 Hz

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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; 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.

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.)
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Saint Petersburg, 196158, Russia

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Gleb Kovalev, MD

CONTACT

+78126004712kovalev2207@gmail.com

Dmitriy Shkarupa, Phd

CONTACT

shkarupa.dmitry@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 22, 2021

Study Start

January 20, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)