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Completed

NCT Number: NCT00222326

The Effect of Physiotherapy Treatment 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.

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Key information

Conditions

Vaginal Hysterectomy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Vaginal Surgery Prolapse

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Physiotherapy, The University of Melbourne

Melbourne, Victoria, 3010, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion criteria

  • surgery for malignancy
  • anti-incontinence surgery
  • laparotomy

Treatment and study plan

Pelvic floor muscle training and lifestyle modification

Behavioral

Primary outcomes

  1. Bladder symptom (prevalence and bother) questionnaire.

    Time frame: Pre-operative compared to 12 months post-operative

    A questionnaire about bladder symptoms

  2. Prolapse symptom (prevalence and bother) questionnaire.

    Time frame: Pre-operative compared to 12 months post-operative

    A questionnaire about prolapse symptoms

Secondary outcomes

  1. Pelvic floor muscle strength.

    Time frame: Pre-operative compared to 12 months post-operative

    Strength assessed via digital muscle testing

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Registry information

Official study title

The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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