The Effect of Physiotherapy Treatment Following Gynaecological Surgery

NCT ID: NCT00222326

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2007-04-30

Brief Summary

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.

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

Conditions

Vaginal Hysterectomy; Pelvic Organ Prolapse Vaginal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pelvic floor muscle training

Pelvic floor muscle training: clinic and rooms exercise training

Group Type: EXPERIMENTAL

Pelvic floor muscle training and lifestyle modification

Intervention Type: BEHAVIORAL

Usual care

Usual care as provided by the surgeon and hospital staff

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pelvic floor muscle training and lifestyle modification

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria

• surgery for malignancy
• anti-incontinence surgery
• laparotomy

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Mary Galea

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary P Galea, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Melbourne, Australia

Locations

School of Physiotherapy, The University of Melbourne

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 15842203 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19816918 (View on PubMed)

Other Identifiers

08-15-10-01

Identifier Type: -

Identifier Source: org_study_id