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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Urinary Incontinence III | Change in the number of urinary incontinence episodes / day at 4 weeks and 8. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Men will be excluded to avoid the potential influence of prostate problems, the main causes of the symptoms described.
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| Name | Affiliation | Role |
|---|---|---|
| AnÃbal Báez-Suárez, PhD | University of Las Palmas de Gran Canaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnÃbal Báez-Suárez | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12493342 | Result | 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. | |
| 15621220 | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| D014570 | Urologic Diseases |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| 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 |
|
| Between the fourth and the eighth week of intervention. |
| 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. |
| Bladder Control Self-Assessment Hyperactive | Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire | After 5 weeks of intervention. |
| 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 |
| 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 |
| 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 |
| 27350947 | 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. |
| 17049716 | 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. |
| 20035977 | 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. |
| 31039103 | 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. |
| 26491706 | 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. |
| 28656519 | 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. |
| 28615976 | 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. |
| 23281067 | 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. |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D011248 | Pregnancy Complications |