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The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Primary Purpose

Vaginal Hysterectomy, Pelvic Organ Prolapse Vaginal Surgery

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Pelvic floor muscle training and lifestyle modification
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Hysterectomy focused on measuring Hysterectomy, Prolapse, Pelvic floor muscles, Bladder, Bowel

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair Exclusion Criteria: surgery for malignancy anti-incontinence surgery laparotomy

Sites / Locations

  • School of Physiotherapy, The University of Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pelvic floor muscle training

Usual care

Arm Description

Pelvic floor muscle training: clinic and rooms exercise training

Usual care as provided by the surgeon and hospital staff

Outcomes

Primary Outcome Measures

Bladder symptom (prevalence and bother) questionnaire.
A questionnaire about bladder symptoms
Prolapse symptom (prevalence and bother) questionnaire.
A questionnaire about prolapse symptoms

Secondary Outcome Measures

Pelvic floor muscle strength.
Strength assessed via digital muscle testing

Full Information

First Posted
September 13, 2005
Last Updated
April 28, 2021
Sponsor
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT00222326
Brief Title
The Effect of Physiotherapy Treatment Following Gynaecological Surgery
Official Title
The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Hysterectomy, Pelvic Organ Prolapse Vaginal Surgery
Keywords
Hysterectomy, Prolapse, Pelvic floor muscles, Bladder, Bowel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training
Arm Type
Experimental
Arm Description
Pelvic floor muscle training: clinic and rooms exercise training
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care as provided by the surgeon and hospital staff
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training and lifestyle modification
Primary Outcome Measure Information:
Title
Bladder symptom (prevalence and bother) questionnaire.
Description
A questionnaire about bladder symptoms
Time Frame
Pre-operative compared to 12 months post-operative
Title
Prolapse symptom (prevalence and bother) questionnaire.
Description
A questionnaire about prolapse symptoms
Time Frame
Pre-operative compared to 12 months post-operative
Secondary Outcome Measure Information:
Title
Pelvic floor muscle strength.
Description
Strength assessed via digital muscle testing
Time Frame
Pre-operative compared to 12 months post-operative

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair Exclusion Criteria: surgery for malignancy anti-incontinence surgery laparotomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Galea, PhD
Organizational Affiliation
The University of Melbourne, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Physiotherapy, The University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
15842203
Citation
Frawley HC, Galea MP, Phillips BA. Survey of clinical practice: pre- and postoperative physiotherapy for pelvic surgery. Acta Obstet Gynecol Scand. 2005 May;84(5):412-8. doi: 10.1111/j.0001-6349.2005.00776.x.
Results Reference
background
PubMed Identifier
19816918
Citation
Frawley HC, Phillips BA, Bo K, Galea MP. Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2010 Jun;29(5):719-25. doi: 10.1002/nau.20828.
Results Reference
result

Learn more about this trial

The Effect of Physiotherapy Treatment Following Gynaecological Surgery

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