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临床试验/NCT00222326
NCT00222326已完成不适用

The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery

University of Melbourne2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2002年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Prolapse symptom (prevalence and bother) questionnaire.

研究概览

简要总结

Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. It is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.

详细描述

Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of pelvic health. It is also known that problems in some of these areas can develop after pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgical phase when tissue repair and scar formation are critical, it is proposed that there will be a reduction in the long-term prevalence of bladder and bowel dysfunction, and weak pelvic floor and abdominal muscles in post-surgical patients. There have been no previous studies investigating whether a physiotherapy intervention can assist pelvic function in this group of surgical patients.

This study aims to investigate the effect of a physiotherapy treatment program on pelvic function following gynaecological surgery.

Comparisons: Pre- and post-operative physiotherapy treatment vs no treatment following gynaecological surgery.

Outcome measures: Pelvic floor muscle strength, urine leakage, quality of life, sexual functioning, general fitness, measured at 3, 6 and 12 months post-operatively

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
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

排除标准

  • surgery for malignancy
  • anti-incontinence surgery
  • laparotomy

结局指标

主要结局

Prolapse symptom (prevalence and bother) questionnaire.

时间窗: Pre-operative compared to 12 months post-operative

A questionnaire about prolapse symptoms

Bladder symptom (prevalence and bother) questionnaire.

时间窗: Pre-operative compared to 12 months post-operative

A questionnaire about bladder symptoms

次要结局

  • Pelvic floor muscle strength.(Pre-operative compared to 12 months post-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Galea

Professor

University of Melbourne

研究点 (2)

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