The Role of the Micro-ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Overactive Bladder questionaire (OAB-q)
研究概览
简要总结
This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will be randomized in two groups. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women (≥ 12 months of amenorrhea or FSH ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for OAB
- •Overactive bladder syndrome (OAB)
- •≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h
- •At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.
排除标准
- •Participants with:
- •Pelvic Organ Prolapse (POP) > stage II of the pelvic organ prolapse quantitation system (POP-Q)
- •Post void residual volume > 200 ml (measured by ultrasound)
- •Use of moisturizers or lubricants the last month
- •Use of vaginal estrogen in the last 6 months
- •Use of drugs for urinary incontinence
- •Use of psychotropic drugs
- •Symptomatic urinary tract infection
- •Active genital infection
- •Kidney or liver disease
- •Abnormal cardiac conduction, rate or rythm disorders
- •Diabetic neuropathy
- •Myasthenia gravis
- •History of malignant disease
- •Previous radio-chemo therapy
结局指标
主要结局
Overactive Bladder questionaire (OAB-q)
时间窗: 24 months
It consists of an 8 item symptom bother scale section and a 25 item health related quality of life scale section (HRQL). Scores of each domain of the 2 sections range from 0 to 100. Higher scores indicate higher impact of overactive bladder symptoms.
3 days voiding diary
时间窗: 24 months
Assesses bladder function (frequency of micturition, urgency and urinary incontinence)
次要结局
- Patients Global Impression of Improvement (PGI-I)(24 months)
- Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)(24 months)
- King's Health Questionnaire (KHQ)(24 months)
- Urogenital Distress Inventory questionaire (UDI-6)(24 months)
研究者
Themos Grigoriadis
Assistant Professor
National and Kapodistrian University of Athens