Effectiveness of Microcurrents Therapy in Overactive Bladder.

Not Applicable

Completed

• Conditions: Overactive Bladder; Urinary Incontinence
• Interventions: Device: Placebo Microcurrents; Device: Microcurrents

• Registration Number: NCT04120545
• Lead Sponsor: University of Las Palmas de Gran Canaria

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

Study Timeline

• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2019-11-04
• Primary Completion: 2021-11-04
• Status Verified: 2021-12
• Study Completion: 2021-12-04
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo microcurrents	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.
Microcurrents	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.

Primary Outcome Measures

Name	Time	Method
Urinary Incontinence	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 Outcome Measures

Name	Time	Method
Urinary Incontinence III	Between the fourth and the eighth week of intervention.	Change in the number of urinary incontinence episodes / day at 4 weeks and 8.
Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).	Through study completion, an average of 1 year	This questionnaire measures the impact of daily sleep in daily activity
Urinary Incontinence II	Between the first and the fourth week of intervention.	Change in the number of urination / day compared to baseline, at the fourth week.
Nocturia	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
Bladder Control Self-Assessment Hyperactive	After 5 weeks of intervention.	Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire
International Consultation on Incontinence questionnaire	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
Quality of life II ( EuroQol-5D)	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).

Trial Locations

Locations (1)

Aníbal Báez-Suárez; 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain