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

Overactive Bladder Clinical Trial

Official title:

A Prospective Multicenter Randomized Blind Placebo-controlled Trial "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578899
• Other study ID #: 1/2020
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2020
• Source: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation
• Contact: Anastasia Zaytseva, MD
• Phone: +79112953055
• Email: zaytseva-anast[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age > 18 years;

2. Signed informed consent;

3. The presence of OAB symptoms: urinary frequency, nocturia, urgency and urge incontinence;

4. The presence of detrusor overactivity patterns based on the results of the urodynamic study (UDI)

Exclusion Criteria:

1. 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).

2. Convulsive attacks in the anamnesis;

3. Taking medications that may trigger the risk of seizures;

4. Pregnancy or suspicion on it;

5. 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.)

6. Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)

7. Pelvic organ prolapse (II-IV stages according to the POP-Q system)

8. The presence of urinary tract infection

9. The presence of tumors of the pelvic organs

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Transvertebral magnetic stimulation
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

Locations

Country	Name	City	State
Russian Federation	Joint-Stock Company "North-Western Centre of Evidence-Based Medicine"	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	Baseline, 4, 12, 24, 48 weeks