NCT00762593Unknown2 期
A Multicenter Double Blind Randomized Placebo Controlled Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence
Akontis2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
研究概览
简要总结
To compare the effectiveness of a transvaginal electrical stimulation by a home use programmable device to a placebo device for urinary incontinence in women
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
- Double (Participant, 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
- •>=18 years old
- •Signed informed consent form
- •Women with urinary stress incontinence defined as follow
- •Involuntary loss of urine during increased abdominal pressure. In case of mix urinary incontinence (i.e., stress urinary incontinence associated to urge urinary incontinence) the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogic scale is higher for stress incontinence than for urge incontinence symptoms.
- •closure pressure between 10 and 60 cm H2O
- •the discomfort related to stress incontinence as evaluated on a 0 (no discomfort) to 100 (maximum discomfort) visual analogical scale is higher than 40/100
- •Patients never treated with transvaginal electrical stimulation
- •Vaginal muscle strength less than 3/5 on the muscular testing
- •Positive Pad test (>2 g of leakage measure by pad test with standardised bladder volume)
排除标准
- •Patient refusing to sign the consent form
- •patient unable to understand or follow the protocol
- •inadequate cognitive ability
- •patient participating in another research protocol within the 3 previous months
- •pregnancy
- •women with no contraception
- •pacemaker
- •history of recent (< 1 year) transvaginal electrical stimulation treatment at home
- •urinary incontinence other than stress incontinence
- •neurological disease
- •permanent metrorrhagia
- •ongoing urinary tract infections
- •vaginal prolapse > 2
- •untreated atrophic vaginitis
- •history of surgical treatment for urinary stress incontinence or genital prolapse
- •recent pelvic surgery (<6 months)
- •anatomic defect that preclude the use of the device
- •genitourinary cancer or colic cancer
- •patient already treated for urinary stress incontinence
- •Recent oestrogen treatment (less than 3 weeks)
结局指标
主要结局
Number of urinary stress incontinence episodes measured by patients on a 7 days diary at 8 weeks
时间窗: 8 weeks
Assessment of the discomfort linked to urinary stress incontinence occurring the previous week assessed on a 0 - 100 visual analog scale at 8 weeks
时间窗: 8 weeks
次要结局
- Urodynamic investigation(4 and 8 weeks)
- Standardised Pad test(4 and 8 weeks)
- Number of severe urinary stress incontinence episodes(4 and 8 weeks)
- Number of sanitary napkins used(4 and 8 weeks)
- Leakage index(4 and 8 weeks)
- Subjective appreciation of patients(4 and 8 weeks)
研究者
研究点 (2)
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