- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00222326
The Effect of Physiotherapy Treatment Following Gynaecological Surgery
The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3010
- School of Physiotherapy, The University of Melbourne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair
Exclusion Criteria:
- surgery for malignancy
- anti-incontinence surgery
- laparotomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pelvic floor muscle training
Pelvic floor muscle training: clinic and rooms exercise training
|
|
No Intervention: Usual care
Usual care as provided by the surgeon and hospital staff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bladder symptom (prevalence and bother) questionnaire.
Time Frame: Pre-operative compared to 12 months post-operative
|
A questionnaire about bladder symptoms
|
Pre-operative compared to 12 months post-operative
|
Prolapse symptom (prevalence and bother) questionnaire.
Time Frame: Pre-operative compared to 12 months post-operative
|
A questionnaire about prolapse symptoms
|
Pre-operative compared to 12 months post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic floor muscle strength.
Time Frame: Pre-operative compared to 12 months post-operative
|
Strength assessed via digital muscle testing
|
Pre-operative compared to 12 months post-operative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary P Galea, PhD, The University of Melbourne, Australia
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-15-10-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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