The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse Vaginal Surgery; Vaginal Hysterectomy
• Interventions: Behavioral: Pelvic floor muscle training and lifestyle modification

• Registration Number: NCT00222326
• Lead Sponsor: University of Melbourne

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2006-04
• Study Completion: 2007-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria

• surgery for malignancy
• anti-incontinence surgery
• laparotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic floor muscle training	Pelvic floor muscle training and lifestyle modification	Pelvic floor muscle training: clinic and rooms exercise training

Primary Outcome Measures

Name	Time	Method
Prolapse symptom (prevalence and bother) questionnaire.	Pre-operative compared to 12 months post-operative	A questionnaire about prolapse symptoms
Bladder symptom (prevalence and bother) questionnaire.	Pre-operative compared to 12 months post-operative	A questionnaire about bladder symptoms

Secondary Outcome Measures

Name	Time	Method
Pelvic floor muscle strength.	Pre-operative compared to 12 months post-operative	Strength assessed via digital muscle testing

Trial Locations

Locations (1)

School of Physiotherapy, The University of Melbourne; 🇦🇺 Melbourne, Victoria, Australia