Overactive BladderNCT04578899
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
A study testing Transvertebral magnetic stimulation in people with Overactive Bladder, run by Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Transvertebral magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 4 Sep 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"
Saint Petersburg, 196158
Aleksey Shmelev, MD, +78126004712, aludm2@mail.ru
About this study
Official title: 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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Transvertebral magnetic stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvertebral magnetic stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Transvertebral magnetic stimulation (Experimental group) | Active comparator | Experimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3). Receives: 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. Receives: Device: Transvertebral magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4, 12, 24, 48 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 4, 12, 24, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start4 Sep 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitriy Shkarupa, Phd, Principal investigator, JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578899
- Sponsor's protocol ID
- 1/2020
- Status last verified
- Oct 2020
- First submitted
- 15 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Blind Placebo-controlled Trial "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
- ClinicalTrials.gov ID
- NCT04578899
- Acronym / sponsor ID
- 1/2020
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian FederationUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transvertebral magnetic stimulation (Experimental group) | Active comparator | Device: Transvertebral magnetic stimulationExperimental intervention will receive non-invasive transvertebral magnetic stimulation of the sacral spine roots (level S2-S3). |
| Transvertebral magnetic stimulation (Control group) | Placebo comparator | Device: Transvertebral magnetic stimulationControl group will receive an equivalent number of "stimulation" sessions using the placebo option. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvertebral magnetic stimulationContinuous 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 | Device | Transvertebral magnetic stimulation (Control group), Transvertebral magnetic stimulation (Experimental group) |
Primary outcome
Change baseline of micturition episodes per day
Time frame: 4, 12, 24, 48 weeks
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.
2 secondary outcomes
OAB-Q SF Change Score
Time frame: Baseline, 4, 12, 24, 48 weeks
PGI-I Change Score
Time frame: Baseline, 4, 12, 24, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitriy Shkarupa, Phd principal investigator
JOINT-STOCK COMPANY "NORTH-WESTERN CENTRE OF EVIDENCE-BASED MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvertebral magnetic stimulation in people with Overactive Bladder, run by Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasia Zaytseva, MD (+79112953055, zaytseva-anast@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change baseline of micturition episodes per day (time frame: 4, 12, 24, 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.