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Completed

NCT Number: NCT04120545

Effectiveness of Microcurrents Therapy in Overactive Bladder.

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microcurrents

Device

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 Microcurrents

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. Bladder Control Self-Assessment Hyperactive

    Time frame: After 5 weeks of intervention.

    Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire

  5. 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

  6. 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

  7. 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).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Las Palmas de Gran Canaria

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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