The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
研究概览
简要总结
This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing mid-urethral sling surgery
- •Have symptoms of both stress and urgency urinary incontinence
- •Able to consent, fill out study documents, and complete all study procedures and follow-up visits
- •At least 18 years of age
- •English speaking
- •Be able and willing to learn clean intermittent self catheterization technique
排除标准
- •History of recurrent UTI (defined as three culture proven UTIs within last 12 months)
- •Systemic neuromuscular disease known to affect the lower urinary tract
- •Undergoing concomitant prolapse surgery
- •Previous incontinence surgery
- •Treatment with anticholinergic medication in the last 2 months
- •Previous bladder injection with onabotulinumtoxinA
- •Prisoner Status
- •Pregnancy
研究组 & 干预措施
OnabotulinumtoxinA injections
100 units of OnabotulinumtoxinA (Botox®) injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
干预措施: OnabotulinumtoxinA (Botox ®) Injections (Drug)
Saline injections
100 units of saline injected into the detrusor (large muscle of the bladder) at the time of sling surgery.
干预措施: Saline Injections (Drug)
结局指标
主要结局
Number of Participants With Self-reported Mixed Urinary Incontinence Symptoms
时间窗: 3 months after surgery
Mixed urinary incontinence symptoms will be assessed by the Patient Global Assessment of Improvement (PGI-I) survey, a patient oriented outcome
次要结局
- Incontinence Episode Frequency(3 months after surgery)
- Urinary Incontinence Symptoms and Quality of Life(3 months after surgery)
研究者
Kimberly Kenton
Professor, Departments of Obstetrics and Gynecology, Urology
Northwestern University