The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Vaginal Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222326
• Other study ID #: 08-15-10-01
• Status: Completed
• Phase: N/A
• Start date: July 2002
• Est. completion date: April 2007

Study information

• Verified date: April 2021
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2007
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria:

• surgery for malignancy
• anti-incontinence surgery
• laparotomy

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Pelvic Organ Prolapse Vaginal Surgery
• Prolapse
• Vaginal Hysterectomy

Intervention

Behavioral:
• Pelvic floor muscle training and lifestyle modification

Locations

Country	Name	City	State
Australia	School of Physiotherapy, The University of Melbourne	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

References & 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. — View Citation

Frawley HC, Phillips BA, Bø 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder symptom (prevalence and bother) questionnaire.	A questionnaire about bladder symptoms	Pre-operative compared to 12 months post-operative
Primary	Prolapse symptom (prevalence and bother) questionnaire.	A questionnaire about prolapse symptoms	Pre-operative compared to 12 months post-operative
Secondary	Pelvic floor muscle strength.	Strength assessed via digital muscle testing	Pre-operative compared to 12 months post-operative