NCT04578899

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Joint-Stock Company North-West Center for Evidence-Based Medicine, Russian Federation · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-04
• Primary completion: 2021-03-01
• Completion: 2021-10-01
• First posted: 2020-10-08
• Last updated: 2020-10-08

Locations

1 site across 1 country: Russia