Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- UDI-LF Total Score Change From Baseline
研究概览
简要总结
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
详细描述
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial.
The purpose of MUSA is to:
- compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI
- characterize patient characteristics associated with treatment response
The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory.
Secondary outcomes include:
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Reporting at least "moderate bother" from UUI item on UDI
- •* "Do you experience urine leakage associated with a feeling of urgency?"
- •Reporting at least "moderate bother" from SUI item on UDI
- •* "Do you experience urine leakage related to physical activity, coughing, or sneezing?"
- •Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
- •Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
- •Urinary symptoms >3 months
- •Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.
- •Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is
- •intolerant of oral overactive bladder medications, or
- •oral overactive bladder medications are contraindicated as determined by the treating provider.
- •Urodynamics within past 18 months
- •Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
排除标准
- •Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
- •* Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible
- •Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
- •* Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment are eligible
- •Women undergoing hysterectomy for any indication will be excluded
- •Active pelvic organ malignancy
- •Age <21 years
- •Pregnant or plans for future pregnancy in next 6 months, or within 12 months post-partum
- •Post-void residual >150 cc on 2 occasions within the past 6 months, or current catheter use
- •Participation in other trial that may influence results of this study
- •Unevaluated hematuria
- •Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence
- •Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
- •Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period
- •Non-ambulatory
- •History of serious adverse reaction to synthetic mesh
- •Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up
- •Diagnosis of and/or history of bladder pain or chronic pelvic pain
- •Women who had intravesical Botox injection within the past 12 months
- •Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months
研究组 & 干预措施
Botox A® injection
A dose of 100 units of Botulinum toxin A will be injected into the bladder. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.
干预措施: Botox® injection (Drug)
Mid-urethral sling
Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.
干预措施: Mid-urethral sling (Device)
结局指标
主要结局
UDI-LF Total Score Change From Baseline
时间窗: 3, 6, 9, and 12 Months
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
次要结局
- UDI-LF Irritative Score Change From Baseline(3, 6, 9, and 12 Months)
- UDI-LF Stress Score Change From Baseline(3, 6, 9, and 12 Months)