Effectiveness of Microcurrents Therapy in Overactive Bladder.

NCT04120545 | Completed

• 1 other identifier: NESAob
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Urinary Incontinence

Keywords

physical therapy modality; Electric Stimulation Therapy; Urologic Diseases; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• Urinary Incontinence

  The reduction of at least 25% urination will be considered successful. This result is measured objectively from the voiding diary.

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Urinary Incontinence II

  Between the first and the fourth week of intervention.

• Urinary Incontinence III

  Between the fourth and the eighth week of intervention.

• Nocturia

  Average number of nocturia episodes measured in a diary of 3 days before each visit.

• Bladder Control Self-Assessment Hyperactive

  After 5 weeks of intervention.

• International Consultation on Incontinence questionnaire

  It will be completed at the beginning of the study, at week 4 and at 8 of the treatment

Other Outcomes (1)

• Blinding effectiveness evaluation

  At 2 weeks after the start of the intervention

Study Arms (2)

Microcurrents

EXPERIMENTAL

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

Device: Microcurrents

Placebo microcurrents

PLACEBO COMPARATOR

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

Device: Placebo Microcurrents

Interventions

Microcurrents DEVICE

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.

Microcurrents

Placebo Microcurrents DEVICE

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

Placebo microcurrents

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men will be excluded to avoid the potential influence of prostate problems, the main causes of the symptoms described.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Study Sites (1)

Aníbal Báez-Suárez

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Related Publications (10)

• 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.

  PMID: 12493342 RESULT

• 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.

  PMID: 15621220 RESULT

• 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.

  PMID: 27350947 RESULT

• 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.

  PMID: 17049716 RESULT

• 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.

  PMID: 20035977 RESULT

• 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.

  PMID: 31039103 RESULT

• 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.

  PMID: 26491706 RESULT

• 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.

  PMID: 28656519 RESULT

• 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.

  PMID: 28615976 RESULT

• 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.

  PMID: 23281067 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Urologic Diseases; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Pregnancy Complications

Study Officials

• Aníbal Báez-Suárez, PhD

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 9, 2019
• Study Start: November 4, 2019
• Primary Completion: November 4, 2021
• Study Completion: December 4, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)