Transvaginal Radiofrequency Ablation With Morpheus Device for Treatment of Overactive Bladder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
研究概览
简要总结
To assess the effectiveness of transvaginal radiofrequency oblation by the Morpheus device at varying depths of penetration for improving urge predominate and urinary incontinence symptoms in women with overactive bladder .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-85 years old
- •Urinary incontinence for ≥ 3 months
- •Reporting at least "moderate bother" on Item 2 on the Urinary Distress Inventor questioner, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
- •If mixed urinary incontinence, urge is reported predominant symptom on MESA score.
- •>10 micturition per 24 hours and >3 urgency episodes on 3-ay bladder diary
- •> 1 UUI episode on 3-day bladder diary
- •Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2-week wash-out period)
排除标准
- •Non-English speakers
- •Severely impaired mobility or cognition
- •Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
- •Repair of pelvic organ prolapse in the previous 6 months
- •Received intravesical botulinum injection within the previous 12 months
- •History of implanted nerve stimulator for incontinence
- •History of prior sling or vaginal mesh placement, UNLESS onset of UUI was completely unrelated to placement and severity was unaffected by mesh placement.
- •Previous diagnosis of Interstitial cystitis
- •Active pelvic organ malignancy
- •History of pelvic radiation
- •Urethral obstruction
- •Urinary retention or prolonged catheter use
- •Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months
- •Untreated symptomatic urinary tract infection
- •Unevaluated hematuria
- •Medical instability
- •Allergy to anesthetics used in the study
- •Not available for follow-up in 6 months
- •Participation in other research trials that could influence results of this study
结局指标
主要结局
To assess the effectiveness of radiofrequency (RF) ablation at varying depths of penetration for improving urge predominate urinary incontinence symptoms
时间窗: 3 months
Measured by The Urogenital Distress Inventory-6 (UDI-6). The Urogenital Distress Inventory-6 (UDI-6) assesses the severity of urogenital symptoms through six questions addressing frequent urination, urgency-related leakage, leakage during physical activity, small amounts of leakage, difficulty emptying the bladder, and pain or discomfort in the lower abdomen or genital region. 0 = Not at all 1. = Slightly 2. = Moderately 3. = Greatly The scores for each item are summed to give a total score, which ranges from 0 to 18. Higher scores indicate greater distress and symptom severity.
次要结局
- To assess the effectiveness of RF ablation assess on urgency and associated life impact(6 months)
- To assess the effectiveness of RF ablation for improving subject-reported incontinence-related quality of life(6 months.)