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The Effect of Physiotherapy Treatment Following Gynaecological Surgery
This study has been completed.
Study NCT00222326   Information provided by University of Melbourne
First Received: September 13, 2005   Last Updated: February 17, 2009   History of Changes

September 13, 2005
February 17, 2009
July 2002
April 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • Bladder questionnaire.
  • Prolapse questionnaire.
  • Bowel questionnaire.
Complete list of historical versions of study NCT00222326 on ClinicalTrials.gov Archive Site
Pelvic floor muscle strength. [ Time Frame: Pre-operative compared to 12 months post-operative ] [ Designated as safety issue: No ]
Pelvic floor muscle strength.
 
The Effect of Physiotherapy Treatment Following Gynaecological Surgery
The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery

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.

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

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
  • Vaginal Hysterectomy,
  • Pelvic Organ Prolapse Vaginal Surgery
Behavioral: Pelvic floor muscle training and lifestyle modification
Experimental: Pelvic floor muscle training: clinic and rooms exercise training
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
April 2007
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria:

  • surgery for malignancy
  • anti-incontinence surgery
  • laparotomy
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00222326
Prof Mary Galea, University of Melbourne
08-15-10-01
University of Melbourne
 
Principal Investigator: Mary P Galea, PhD The University of Melbourne, Australia
University of Melbourne
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP