跳至主要内容
临床试验/NCT04817839
NCT04817839已完成不适用

Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures

Yale University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
1
主要终点
Change in urogenital distress inventory (UDI) stress score

研究概览

简要总结

The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.

详细描述

This is a blinded, randomized controlled trial. Patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. If eligible and willing to participate, patients will be randomized to a "3 weeks post-operative restriction" or "6-week post-operative restriction" of activities group.

Currently, pelvic surgeons' recommendations for activity and lifting restrictions during post-operative period vary widely from 1 to 50 pounds (10). Given variation in literature and reasonable expectations for lifting restrictions, 20-pound lifting restriction was considered to be a reasonable and attainable expectation from patients. Both groups will be given an identical set of postoperative instructions which include refrainment from lifting anything over 20 pounds, avoid strenuous exercise, running, or perform high-impact aerobic activities during the restricted activity period. Depending on their random allocation, patients will follow these instructions either for 3 or 6 postoperative weeks. The activities which all patients will be allowed to do during their postoperative recovery include walking, using stairs and showering in both groups. All patient will be asked to refrain from sexual intercourse for 6 weeks consistent with current routine post op recommendations (6). Other than the time of activity restriction post op (heavy lifting, strenuous exercise, running, high impact exercise), patients will receive identical postoperative instructions otherwise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (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

入选标准

  • At least 18 years of age,
  • Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence

排除标准

  • • Patients who are unable to read, understand, or complete study documents in English or Spanish
  • Patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling
  • Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)

研究组 & 干预措施

3-week post-operative activity restriction

Experimental

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.

干预措施: 3-week post-operative activity restriction (Behavioral)

6-week post-operative activity restriction

Experimental

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.

干预措施: 6-week post-operative activity restriction (Behavioral)

结局指标

主要结局

Change in urogenital distress inventory (UDI) stress score

时间窗: Baseline, 6 Months

UDI form calculator assesses life quality and symptom distress in women suffering from urinary incontinence. The range is 0 to 70, higher means worse, lowers means better (higher is more symptoms.

次要结局

  • Change in cough stress test(6 months, 1 year)
  • Patient Global Impression of Improvement (PGI-I)(6 months)
  • Change in Patient Satisfaction Post-Operative Questionnaire(6 weeks, 6 months, and 1 year)
  • Activity Assessment Scale (AAS)(3 weeks)
  • Incontinence Impact Questionnaire Short Form (IIQ-7)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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