Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- postoperative quality of life as based on the scores of the WHO-QOL Bref in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence
研究概览
简要总结
i) The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence.
ii) Secondary objectives include:
- Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
- Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care;
- Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care;
- Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.
详细描述
This is a single center randomized controlled trial assessing quality of life in participants following vaginal surgery receiving physical therapy compared to standard postoperative care. Patients will be under care of the physicians of the Division of Urogynecology and Reconstructive Pelvic Surgery. All physicians are board certified, fellowship trained urogynecologists.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Vaginal reconstructive surgery for prolapse
- •Age of at least 18 years
- •Willing to comply with physical therapy
排除标准
- •i. Use of mesh/graft material during the prolapse repair
- •ii. Abdominal or laparoscopic prolapse repair
- •iii.Current genitourinary fistula or urethral diverticulum
- •iv. Contraindication to surgery
- •v. Unable to comply with physical therapy or office visits
- •vi. Preexisting neurological condition
- •vii.Concurrent surgery for fecal incontinence
结局指标
主要结局
postoperative quality of life as based on the scores of the WHO-QOL Bref in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence
时间窗: 3-6 months
Quality of life scores on the world health organization validated quality of life scale
次要结局
- Comparing pelvic floor quality of life scores and distress related to pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care(3-6 months)
- Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;(3-6 months)