IMpact of Unrestricted ACTIVity Following Mid-Urethral Sling Surgery (I'M ACTIVe): Quality of Life and Cost Implications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.
研究概览
简要总结
To determine the impact of unrestricted postoperative activity on intermediate- and long-term continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence.
To assess the natural return to baseline activity level when patients are unrestricted following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic organ prolapse repair.
详细描述
Over the last decade, the mid-urethral sling has become the new gold standard in the management of stress urinary incontinence because of its high success rate and minimally invasive nature. However, postoperative management has not kept pace with the modernization of sling surgery. Although formal guidelines regarding the resumption of normal activity levels have not been established, it is general practice to restrict exercise for a minimum of six weeks after surgery.
For the study, if immediate resumption of normal activity has no impact on intermediate- and long-term continence outcomes, it may result in improved quality of life and cost savings from a societal perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant female
- •Self-reported stress urinary incontinence
- •Incontinence demonstrated on physical exam and/or by an urodynamics study
- •Planned mid-urethral sling surgery
- •Available for 2 years of follow-up
- •Willing and able to complete study assessments per the judgment of the treating clinician
- •Willing and able to provide written informed consent
排除标准
- •Age <18 years at time of enrollment
- •Concomitant prolapse surgery other than anterior colporrhaphy
- •Currently pregnant or <12 months post-partum
- •Unable to read, write, or comprehend English
研究组 & 干预措施
Standard post-operative activity restriction
As a traditional method, patients will be restricted from activity for six weeks after sling surgery.
干预措施: Standard post-operative activity restriction (Other)
No post-operative activity restrictions
Patients are to resume regular activity immediately after mid-urethral sling surgery.
干预措施: No post-operative activity restrictions (Other)
结局指标
主要结局
Unrestricted postoperative physical activity for surgical outcomes measure by questionnaire assessment.
时间窗: 2 years
Return to normal activity immediately after mid-urethral sling surgery could result in faster return to baseline health-related quality of life. Each questionnaire will be administered weekly following surgery until the patient returns to within 10% of baseline scores. Cost-effectiveness of early return to normal activity via Productivity Loss form as time spent recovering from surgery will be analyzed (incremental cost effectiveness ratio of net means by comparing the unrestricted and restricted groups).
次要结局
未报告次要终点
研究者
Jennifer T. Anger
Principal Investigator
Cedars-Sinai Medical Center