Effectiveness of Microcurrents Therapy in Overactive Bladder.
NCT ID: NCT04120545
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2019-11-04
2021-12-04
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number.
Placebo Microcurrents
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
Interventions
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Microcurrents
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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University of Las Palmas de Gran Canaria
OTHER
Responsible Party
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Aníbal Báez Suárez
Clinical Professor
Principal Investigators
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Aníbal Báez-Suárez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Las Palmas de Gran Canaria
Locations
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Aníbal Báez-Suárez
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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References
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Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. doi: 10.1016/s0090-4295(02)01784-3.
Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004 Dec;64(6 Suppl 1):2-6. doi: 10.1016/j.urology.2004.10.047.
Eapen RS, Radomski SB. Review of the epidemiology of overactive bladder. Res Rep Urol. 2016 Jun 6;8:71-6. doi: 10.2147/RRU.S102441. eCollection 2016.
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
Ganz ML, Smalarz AM, Krupski TL, Anger JT, Hu JC, Wittrup-Jensen KU, Pashos CL. Economic costs of overactive bladder in the United States. Urology. 2010 Mar;75(3):526-32, 532.e1-18. doi: 10.1016/j.urology.2009.06.096. Epub 2009 Dec 29.
Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
de Groat WC, Tai C. Impact of Bioelectronic Medicine on the Neural Regulation of Pelvic Visceral Function. Bioelectron Med. 2015 Jan 22;2015:25-36.
Jaqua K, Powell CR. Where Are We Headed with Neuromodulation for Overactive Bladder? Curr Urol Rep. 2017 Aug;18(8):59. doi: 10.1007/s11934-017-0711-x.
Janssen DA, Martens FM, de Wall LL, van Breda HM, Heesakkers JP. Clinical utility of neurostimulation devices in the treatment of overactive bladder: current perspectives. Med Devices (Auckl). 2017 Jun 1;10:109-122. doi: 10.2147/MDER.S115678. eCollection 2017.
Timmermans L, Falez F, Melot C, Wespes E. Validation of use of the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) for impairment rating: a transversal retrospective study of 120 patients. Neurourol Urodyn. 2013 Sep;32(7):974-9. doi: 10.1002/nau.22363. Epub 2012 Dec 31.
Other Identifiers
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NESAob
Identifier Type: -
Identifier Source: org_study_id