Virtual Bladder Training for Overactive Bladder Syndrome in Women. Which Symptom Responds Better?
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in King's Health Questionnaire (KHQ) score
研究概览
简要总结
According to International Urogynecological Association and International Continence Society joint report on the terminology for female pelvic floor dysfunction, overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. Bladder training lasting for a minimum of 4 to 6 weeks is indicated as a first-line treatment. The investigators' goal is to compare changes in satisfaction, measured in terms of quality of life, in 2 groups of women with different main accompanying symptoms in OAB (frequency vs. nocturia), before and after bladder training utilizing telemedicine (virtual bladder training), for 4 to 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Live in Buenos Aires City
- •Overactive Bladder Syndrome
- •Access to virtual appointment
排除标准
- •Previous overactive bladder syndrome treatment.
- •Prior stress urinary incontinence or pelvic organ prolapse surgery.
- •History of Neurogenic Bladder, pelvic organs prolapse or pelvic radiation.
- •Pregnancy.
研究组 & 干预措施
Frequency
Main symptom: Increased daytime urinary frequency: complaint that micturition occurs more frequently during waking hours than previously deemed normal by the woman.
干预措施: Bladder training (Other)
Nocturia
Main symptom: Complaint of interruption of sleep one or more times because of the need to micturate.
干预措施: Bladder training (Other)
结局指标
主要结局
Change in King's Health Questionnaire (KHQ) score
时间窗: Change from Baseline King's Health Questionnaire at 6 weeks
KHQ score: 0-100 points per domain. Higher scores mean a worse outcome.Ten points change in KHQ score, before and after bladder training.
Change in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) score
时间窗: Change from Baseline International Consultation on Incontinence Questionnaire Short Form at 6 weeks
ICIQ SF score: 0-21 points. Higher scores mean a worse outcome. Three points change in ICIQ-SF score, before and after bladder training.
次要结局
未报告次要终点
研究者
AGUSTINA VENDRAMINI
Principal Investigator
Hospital Italiano de Buenos Aires