The Effect of Physiotherapy Treatment Following Gynaecological Surgery - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title:	The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy Pelvic Support Problems Surgery

U.S. FDA Resources

Further study details as provided by University of Melbourne:

Primary Outcome Measures:

Bladder symptom (prevalence and bother) questionnaire. [ Time Frame: Pre-operative compared to 12 months post-operative ] [ Designated as safety issue: No ]
Prolapse symptom (prevalence and bother) questionnaire. [ Time Frame: Pre-operative compared to 12 months post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pelvic floor muscle strength. [ Time Frame: Pre-operative compared to 12 months post-operative ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	July 2002
Study Completion Date:	April 2007
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pelvic floor muscle training: Experimental Pelvic floor muscle training: clinic and rooms exercise training	Behavioral: Pelvic floor muscle training and lifestyle modification

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

Eligibility

Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222326

Locations

Australia, Victoria
School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, Australia, 3010

Sponsors and Collaborators

University of Melbourne

Investigators

Principal Investigator:

Mary P Galea, PhD

The University of Melbourne, Australia

More Information

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.

Responsible Party:	University of Melbourne ( Prof Mary Galea )
Study ID Numbers:	08-15-10-01
Study First Received:	September 13, 2005
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00222326 History of Changes
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by University of Melbourne:

Hysterectomy,
Prolapse,
Pelvic floor muscles,
Bladder,
Bowel.

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on November 25, 2009