Effectiveness of Microcurrents Therapy in Overactive Bladder : Controlled and Randomized Triple Blind Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- University of Las Palmas de Gran Canaria
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Urinary Incontinence
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Aníbal Báez Suárez
Clinical Professor
University of Las Palmas de Gran Canaria
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.
Outcomes
Primary Outcomes
Urinary Incontinence
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.
Secondary Outcomes
- Urinary Incontinence III(Between the fourth and the eighth week of intervention.)
- Spanish Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ-10SV).(Through study completion, an average of 1 year)
- Urinary Incontinence II(Between the first and the fourth 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)
- Quality of life II ( EuroQol-5D)(Through study completion, an average of 1 year)