Effectiveness of Microcurrents Therapy in Overactive Bladder.

December 10, 2021 updated by: Aníbal Báez Suárez, University of Las Palmas de Gran Canaria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Aníbal Báez-Suárez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microcurrents
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

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.
Placebo Comparator: Placebo microcurrents
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Incontinence
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Between the first and the fourth week of intervention.
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
Time Frame: Between the fourth and the eighth week of intervention.
Change in the number of urinary incontinence episodes / day at 4 weeks and 8.
Between the fourth and the eighth week of intervention.
Nocturia
Time Frame: Average number of nocturia episodes measured in a diary of 3 days before each visit.
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
Time Frame: After 5 weeks of intervention.
Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire
After 5 weeks of intervention.
International Consultation on Incontinence questionnaire
Time Frame: It will be completed at the beginning of the study, at week 4 and at 8 of the treatment
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).
Time Frame: Through study completion, an average of 1 year
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)
Time Frame: Through study completion, an average of 1 year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blinding effectiveness evaluation
Time Frame: At 2 weeks after the start of the intervention
The participants, evaluators and those who apply the intervention will be asked if they know the research group to which the study subject belongs through a questionnaire prepared by one of the principal investigators.
At 2 weeks after the start of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Las Palmas de Gran Canaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

December 4, 2021

Study Registration Dates

First Submitted

October 6, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NESAob

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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