Clinical trial NCT04120545: Effectiveness of Microcurrents Therapy in Overactive Bladder.
Official title: Effectiveness of Microcurrents Therapy in Overactive Bladder : Controlled and Randomized Triple Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urinary Incontinence
Keywords: physical therapy modality
Electric Stimulation Therapy
Urologic Diseases
Pelvic Floor Disorders
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Urinary Incontinence
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Urinary Incontinence II
timeFrame: Between the first and the fourth week of intervention.
measure: Urinary Incontinence III
timeFrame: Between the fourth and the eighth week of intervention.
measure: Nocturia
timeFrame: Average number of nocturia episodes measured in a diary of 3 days before each visit.
measure: Bladder Control Self-Assessment Hyperactive
timeFrame: After 5 weeks of intervention.
measure: International Consultation on Incontinence questionnaire
timeFrame: It will be completed at the beginning of the study, at week 4 and at 8 of the treatment
measure: Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).
timeFrame: Through study completion, an average of 1 year
measure: Quality of life II ( EuroQol-5D)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Blinding effectiveness evaluation
timeFrame: At 2 weeks after the start of the intervention
Locations:
city: Las Palmas de Gran Canaria
country: Spain
facility: Aníbal Báez-Suárez
state: Las Palmas
Study officials:
affiliation: University of Las Palmas de Gran Canaria
name: Aníbal Báez-Suárez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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