Effectiveness of Microcurrents Therapy in Overactive Bladder.

Urinary Incontinence Clinical Trial

Official title:

Effectiveness of Microcurrents Therapy in Overactive Bladder : Controlled and Randomized Triple Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120545
• Other study ID #: NESAob
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 4, 2021

Study information

• Verified date: December 2021
• Source: University of Las Palmas de Gran Canaria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	Aníbal Báez-Suárez	Las Palmas de Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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 t — View Citation

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 — View Citation

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. Review. — View Citation

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. — View Citation

Timmermans L, Falez F, Mélot 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 Ur — View Citation

Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology. 2004 Dec;64(6 Suppl 1):2-6. Review. — View Citation

Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blinding effectiveness evaluation	The participants, evaluators and those who apply the intervention will be asked if they know the research group to which the study subject belongs through a questionnaire prepared by one of the principal investigators.	At 2 weeks after the start of the intervention
Primary	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	Urinary Incontinence II	Change in the number of urination / day compared to baseline, at the fourth week.	Between the first and the fourth week of intervention.
Secondary	Urinary Incontinence III	Change in the number of urinary incontinence episodes / day at 4 weeks and 8.	Between the fourth and the eighth week of intervention.
Secondary	Nocturia	Change in the number of nocturia episodes every 24 hours	Average number of nocturia episodes measured in a diary of 3 days before each visit.
Secondary	Bladder Control Self-Assessment Hyperactive	Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire	After 5 weeks of intervention.
Secondary	International Consultation on Incontinence questionnaire	It is a questionnaire in which the experience is answered daily individual urination and incontinence	It will be completed at the beginning of the study, at week 4 and at 8 of the treatment
Secondary	Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).	This questionnaire measures the impact of daily sleep in daily activity	Through study completion, an average of 1 year
Secondary	Quality of life II ( EuroQol-5D)	The main problems or difficulties are collected by patients in 5 dimensions (mobility, self-care, daily activities, pain / discomfort level and anxiety / depression level).	Through study completion, an average of 1 year