Effectiveness of Microcurrents Therapy in Overactive Bladder : Controlled and Randomized Triple Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Urinary Incontinence
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Microcurrents
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number.
干预措施: Microcurrents (Device)
Placebo microcurrents
Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7, L3 or S1 level depending on the session number.
干预措施: Placebo Microcurrents (Device)
结局指标
主要结局
Urinary Incontinence
时间窗: 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.
次要结局
- 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)
- 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.)
研究者
Aníbal Báez Suárez
Clinical Professor
University of Las Palmas de Gran Canaria