The Effect of Physiotherapy Treatment Following Gynaecological Surgery

NCT00222326 | Completed

• 1 other identifier: 08-15-10-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Hysterectomy; Pelvic Organ Prolapse Vaginal Surgery

Keywords

Hysterectomy; Prolapse; Pelvic floor muscles; Bladder; Bowel

Outcome Measures

Primary Outcomes (2)

• Bladder symptom (prevalence and bother) questionnaire.

  A questionnaire about bladder symptoms

  Pre-operative compared to 12 months post-operative

• Prolapse symptom (prevalence and bother) questionnaire.

  A questionnaire about prolapse symptoms

  Pre-operative compared to 12 months post-operative

Secondary Outcomes (1)

• Pelvic floor muscle strength.

  Pre-operative compared to 12 months post-operative

Study Arms (2)

Pelvic floor muscle training

EXPERIMENTAL

Pelvic floor muscle training: clinic and rooms exercise training

Behavioral: Pelvic floor muscle training and lifestyle modification

Usual care

NO INTERVENTION

Usual care as provided by the surgeon and hospital staff

Interventions

Pelvic floor muscle training and lifestyle modification BEHAVIORAL

Pelvic floor muscle training

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

You may not qualify if:

• surgery for malignancy
• anti-incontinence surgery
• laparotomy

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

School of Physiotherapy, The University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (2)

• 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.

  PMID: 15842203 BACKGROUND

• 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.

  PMID: 19816918 RESULT

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary P Galea, PhD

  The University of Melbourne, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2002
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2007
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

AU (1)