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| Sponsored by: |
University of Melbourne |
| Information provided by: | University of Melbourne |
| ClinicalTrials.gov Identifier: | NCT00222326 |
Purpose
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 | Intervention |
|
Vaginal Hysterectomy, Pelvic Organ Prolapse Vaginal Surgery |
Behavioral: Pelvic floor muscle training and lifestyle modification |
| MedlinePlus related topics: | Hysterectomy Pelvic Support Problems |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | April 2006 |
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
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, Victoria | |||||
| School of Physiotherapy, The University of Melbourne | |||||
| Melbourne, Victoria, Australia, 3124 | |||||
| University of Melbourne |
| Principal Investigator: | Mary P Galea, PhD | The University of Melbourne, Australia |
More Information
| Study ID Numbers: | 08-15-10-01 |
| First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00222326 |
| Health Authority: | Australia: National Health and Medical Research Council |
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