NCT04120545

Effectiveness of Microcurrents Therapy in Overactive Bladder.

Effectiveness of Microcurrents Therapy in Overactive Bladder : Controlled and Randomized Triple Blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect on the overactive bladder in women using a care protocol plus the application of microcurrent patches during 1 hours per session compared to the effect of the same protocol plus placebo electric stimulation.

Detailed description

The design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control. The size of the sample will be 56 participants who come to referral hospitals. They will be randomized in two groups: control or experimental. The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention. The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p \<0.05

Conditions

• Overactive Bladder
• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Microcurrents	The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7, L3 or S1. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.
DEVICE	Placebo Microcurrents	The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents

Timeline

• Start date: 2019-11-04
• Primary completion: 2021-11-04
• Completion: 2021-12-04
• First posted: 2019-10-09
• Last updated: 2021-12-14

Locations

1 site across 1 country: Spain