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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
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.
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
Aníbal Báez-Suárez
Las Palmas de Gran Canaria, Las Palmas, Spain
Urinary Incontinence
The reduction of at least 25% urination will be considered successful. This result is measured objectively from the voiding diary.
Time frame: Through study completion, an average of 1 year
Urinary Incontinence II
Change in the number of urination / day compared to baseline, at the fourth week.
Time frame: Between the first and the fourth week of intervention.
Urinary Incontinence III
Change in the number of urinary incontinence episodes / day at 4 weeks and 8.
Time frame: Between the fourth and the eighth week of intervention.
Nocturia
Change in the number of nocturia episodes every 24 hours
Time frame: Average number of nocturia episodes measured in a diary of 3 days before each visit.
Bladder Control Self-Assessment Hyperactive
Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire
Time frame: After 5 weeks of intervention.
International Consultation on Incontinence questionnaire
It is a questionnaire in which the experience is answered daily individual urination and incontinence
Time frame: It will be completed at the beginning of the study, at week 4 and at 8 of the treatment
Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).
This questionnaire measures the impact of daily sleep in daily activity
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Time frame: Through study completion, an average of 1 year
Quality of life II ( EuroQol-5D)
The main problems or difficulties are collected by patients in 5 dimensions (mobility, self-care, daily activities, pain / discomfort level and anxiety / depression level).
Time frame: Through study completion, an average of 1 year