Back to results

Effectiveness of Microcurrents Therapy in Overactive Bladder.

Primary Purpose

Overactive Bladder, Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Microcurrents

Placebo Microcurrents

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring physical therapy modality, Electric Stimulation Therapy, Urologic Diseases, Pelvic Floor Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Aníbal Báez-Suárez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Microcurrents

Placebo microcurrents

Arm Description

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

Outcomes

Primary Outcome Measures

Urinary Incontinence

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

Secondary Outcome Measures

Urinary Incontinence II

Change in the number of urination / day compared to baseline, at the fourth week.

Urinary Incontinence III

Change in the number of urinary incontinence episodes / day at 4 weeks and 8.

Nocturia

Change in the number of nocturia episodes every 24 hours

Bladder Control Self-Assessment Hyperactive

Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire

International Consultation on Incontinence questionnaire

It is a questionnaire in which the experience is answered daily individual urination and incontinence

Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).

This questionnaire measures the impact of daily sleep in daily activity

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).

Full Information

NCT ID

NCT04120545

First Posted

October 6, 2019

Last Updated

December 10, 2021

Sponsor

University of Las Palmas de Gran Canaria

1. Study Identification

Unique Protocol Identification Number

NCT04120545

Brief Title

Effectiveness of Microcurrents Therapy in Overactive Bladder.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

November 4, 2021 (Actual)

Study Completion Date

December 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Las Palmas de Gran Canaria

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Urinary Incontinence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microcurrents

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo microcurrents

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Microcurrents

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Placebo Microcurrents

Intervention Description

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

Primary Outcome Measure Information:

Title

Urinary Incontinence

Description

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

Time Frame

Through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Urinary Incontinence II

Description

Change in the number of urination / day compared to baseline, at the fourth week.

Time Frame

Between the first and the fourth week of intervention.

Title

Urinary Incontinence III

Description

Change in the number of urinary incontinence episodes / day at 4 weeks and 8.

Time Frame

Between the fourth and the eighth week of intervention.

Title

Nocturia

Description

Change in the number of nocturia episodes every 24 hours

Time Frame

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

Title

Bladder Control Self-Assessment Hyperactive

Description

Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire

Time Frame

After 5 weeks of intervention.

Title

International Consultation on Incontinence questionnaire

Description

It is a questionnaire in which the experience is answered daily individual urination and incontinence

Time Frame

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

Title

Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).

Description

This questionnaire measures the impact of daily sleep in daily activity

Time Frame

Through study completion, an average of 1 year

Title

Quality of life II ( EuroQol-5D)

Description

The main problems or difficulties are collected by patients in 5 dimensions (mobility, self-care, daily activities, pain / discomfort level and anxiety / depression level).

Time Frame

Through study completion, an average of 1 year

Other Pre-specified Outcome Measures:

Title

Blinding effectiveness evaluation

Description

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.

Time Frame

At 2 weeks after the start of the intervention

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Men will be excluded to avoid the potential influence of prostate problems, the main causes of the symptoms described.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aníbal Báez-Suárez, PhD

Organizational Affiliation

University of Las Palmas de Gran Canaria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aníbal Báez-Suárez

City

Las Palmas de Gran Canaria

State/Province

Las Palmas

ZIP/Postal Code

35016

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12493342

Citation

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.

Results Reference

result

PubMed Identifier

15621220

Citation

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.

Results Reference

result

PubMed Identifier

27350947

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.

Results Reference

result

PubMed Identifier

17049716

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 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.

Results Reference

result

PubMed Identifier

20035977

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.

Results Reference

result

PubMed Identifier

31039103

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.

Results Reference

result

PubMed Identifier

26491706

Citation

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.

Results Reference

result

PubMed Identifier

28656519

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.

Results Reference

result

PubMed Identifier

28615976

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 2017.

Results Reference

result

PubMed Identifier

23281067

Citation

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.

Results Reference

result

Learn more about this trial

Effectiveness of Microcurrents Therapy in Overactive Bladder.

We'll reach out to this number within 24 hrs