Aníbal Báez-Suárez
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
NCT Number: NCT04120545
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Through study completion, an average of 1 year
The reduction of at least 25% urination will be considered successful. This result is measured objectively from the voiding diary.
Time frame: Between the first and the fourth week of intervention.
Change in the number of urination / day compared to baseline, at the fourth week.
Time frame: Between the fourth and the eighth week of intervention.
Change in the number of urinary incontinence episodes / day at 4 weeks and 8.
Time frame: Average number of nocturia episodes measured in a diary of 3 days before each visit.
Change in the number of nocturia episodes every 24 hours
Time frame: After 5 weeks of intervention.
Changes in the value of the Hyperactive Bladder Control Self-Assessment Questionnaire
Time frame: It will be completed at the beginning of the study, at week 4 and at 8 of the treatment
It is a questionnaire in which the experience is answered daily individual urination and incontinence
Time frame: Through study completion, an average of 1 year
This questionnaire measures the impact of daily sleep in daily activity
Time frame: Through study completion, an average of 1 year
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: At 2 weeks after the start of the intervention
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.
University of Las Palmas de Gran Canaria
Other
Effectiveness of Microcurrents Therapy in Overactive Bladder : Controlled and Randomized Triple Blind Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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