Effectiveness of Microcurrents Therapy in Overactive Bladder.

Study Overview
=================
Brief 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

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

Conditions
-----------------
Overactive Bladder, Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Microcurrents
* Device: Placebo Microcurrents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, over 18 years of age and with urinary incontinence (3 or more times per week) or overactive bladder (8 or more emptied per day, and / or 2 or more at night) who have received, or not, active / alternative treatment for this pathology. Under competent cognitive conditions to participate in the study and trained to complete the study questionnaires. Without contraindications for a treatment with microcurrents: Pacemakers, pregnant women, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia. Exclusion Criteria: People with lifestyle habits (diet, amount of fluid ingested) extreme or singular (eg person who consumes 5 liters of water a day). Presence of urinary fistula. Men. Men will be excluded to avoid the potential influence of prostate problems, the main causes of the symptoms described. Urinary tract infection, or relapses: 5 or more infections in the last 12 months. Participants with bladder stones. Hematuria during the trial period. Pregnancy or plans for it during the study. The patient has had a hysterectomy. Pathology of the central or peripheral nervous system. Diabetes without controlled and guaranteed medical treatment its stabilization. Diabetes that affects the peripheral nerves. Treated with anticoagulant. Current use of anticholinergics and beta adrenergic use in the last 4 weeks. Currently treated with botox injections for the bladder or in the last year. Current treatment with interstim or interstim device currently implanted. Obstruction of the bladder outlet. Urinary retention. Painful bladder syndrome / interstitial cystitis. Treatment with more than two antidepressants and / or multiple benzodiazepines, as well as anti-epileptics.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microcurrents<br>Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number. | Device: Microcurrents<br>* 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.<br>|
| Placebo Comparator: Placebo microcurrents<br>Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number. | Device: Placebo Microcurrents<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Incontinence | The reduction of at least 25% urination will be considered successful. This result is measured objectively from the voiding diary. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Incontinence II | Change in the number of urination / day compared to baseline, at the fourth week. | 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. | Between the fourth and the eighth week of intervention. | 
| Nocturia | Change in the number of nocturia episodes every 24 hours | 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 | 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 | 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 | 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). | Through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical therapy modality, Electric Stimulation Therapy, Urologic Diseases, Pelvic Floor Disorders