Effectiveness of Microcurrents Therapy in Overactive Bladder.

University of Las Palmas de Gran Canaria

Status: Completed

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Device: Microcurrents; Device: Placebo Microcurrents

Study type: Interventional

Funder types: Other

Identifiers

NCT04120545

NESAob

Details and patient eligibility

About

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.

Full 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

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Microcurrents

Experimental group

Description:

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number.

Treatment:

Device: Microcurrents

Placebo microcurrents

Placebo Comparator group

Description:

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number.

Treatment:

Device: Placebo Microcurrents