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The Effect of Physiotherapy Treatment Following Gynaecological Surgery

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ClinicalTrials.gov Identifier: NCT00222326
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Vaginal Hysterectomy, Pelvic Organ Prolapse Vaginal Surgery Behavioral: Pelvic floor muscle training and lifestyle modification Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
Study Start Date : July 2002
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2007

Arm Intervention/treatment
Experimental: Pelvic floor muscle training
Pelvic floor muscle training: clinic and rooms exercise training
Behavioral: Pelvic floor muscle training and lifestyle modification



Primary Outcome Measures :
  1. Bladder symptom (prevalence and bother) questionnaire. [ Time Frame: Pre-operative compared to 12 months post-operative ]
  2. Prolapse symptom (prevalence and bother) questionnaire. [ Time Frame: Pre-operative compared to 12 months post-operative ]

Secondary Outcome Measures :
  1. Pelvic floor muscle strength. [ Time Frame: Pre-operative compared to 12 months post-operative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria:

  • surgery for malignancy
  • anti-incontinence surgery
  • laparotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222326


Locations
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Australia, Victoria
School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, Australia, 3010
Sponsors and Collaborators
University of Melbourne
Investigators
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Principal Investigator: Mary P Galea, PhD The University of Melbourne, Australia
Publications:
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Responsible Party: Prof Mary Galea, University of Melbourne
ClinicalTrials.gov Identifier: NCT00222326    
Other Study ID Numbers: 08-15-10-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009
Keywords provided by University of Melbourne:
Hysterectomy,
Prolapse,
Pelvic floor muscles,
Bladder,
Bowel.
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical