Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation in Women With Urinary Incontinence: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Improvement in pelvic floor muscles functionality
研究概览
简要总结
Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical stimulation to the pelvic floor muscles functionality in women with urinary incontinence and who are unable to voluntarily contract their pelvic floor muscles.
Study Design: Randomized controlled trial
详细描述
- The purpose of this study is to find out the effect of vibratory perineal stimulus compared to transvaginal electrical stimulation on the functionality of pelvic floor muscles in women with urinary incontinence who are unable to perform voluntary contraction of this musculature.
- Study Design: Randomized controlled trial
- Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed.and in the Clinical Research Center of the same hospital.
- Inclusion criteria: women with urinary incontinence with zero or one strength degree of pelvic floor muscle contraction by the Modified Oxford Scale.
- Main outcome: Improvement the functionality of pelvic floor muscles
- Secondary outcome: Improvement of urinary loss
- First protocol: patients will be referred by the medical team and will undergo physiotherapeutic evaluation to collect personal data, check the symptoms of urinary incontinence, apply a quality of life questionnaire and measure pelvic floor muscles strength. If patient has zero or one degree of pelvic floor muscle strength, will be referred to the second phase.
- Second protocol: Patients will be randomized into two groups - Vibratory stimulus group or electrical stimulation group. Both will follow a 6-week treatment protocol with intervention once a week. Both are intravaginal devices applied for 20 minutes, with on cycle of 8 seconds and off cycle of 16 seconds.
- Final protocol: patients will repeat the initial evaluation.
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
- Single (Investigator)
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
- •Clinical diagnosis of urinary incontinence;
- •To be unable to perform a voluntarily contraction of pelvic floor muscles;
- •Understand the instruments used in the research;
排除标准
- •Allergy to latex;
- •Individual or group pelvic floor muscle training in the last 6 months.
研究组 & 干预措施
Vibratory Perineal Stimulus
It's thought that the vibratory perineal stimulation can produces afferent nerve impulses that goes to the sacral spinal cord (S2-S4) via the pudendal nerve and stimulates the sacral somatic response which will cause the pelvic muscle contraction.
干预措施: Vibratory Perineal Stimulus (Other)
Transvaginal Electrical Stimulation
Transvaginal electrical stimulation can produces direct and reflex responses of the pelvic floor muscles, being more effective in patients who can't voluntarily contract this musculature. In addition, it increases blood flow to the muscles, restores neuromuscular connections and improves muscle fiber function.
干预措施: Transvaginal Electrical Stimulation (Other)
结局指标
主要结局
Improvement in pelvic floor muscles functionality
时间窗: six weeks
Will be assessed by the PERFECT scheme. Each letter that compose the word means a condition to be evaluated: P = power, E = endurance, R = repetitions, F = fast contractions, E = elevation, C=co-contraction, T= cough reflex.
次要结局
- Improvement of urinary Incontinence(six weeks)