Status:
COMPLETED
Effectiveness of Microcurrents Therapy in Overactive Bladder.
Lead Sponsor:
University of Las Palmas de Gran Canaria
Conditions:
Overactive Bladder
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04120545
Start Date
November 4 2019
End Date
December 4 2021
Last Update
December 14 2021
Active Locations (1)
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1
Aníbal Báez-Suárez
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016