Clinical trial NCT00222326: The Effect of Physiotherapy Treatment Following Gynaecological Surgery
Official title: The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Hysterectomy
Pelvic Organ Prolapse Vaginal Surgery
Keywords: Hysterectomy
Prolapse
Pelvic floor muscles
Bladder
Bowel
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria:

* surgery for malignancy
* anti-incontinence surgery
* laparotomy

Primary outcomes:
measure: Bladder symptom (prevalence and bother) questionnaire.
timeFrame: Pre-operative compared to 12 months post-operative
measure: Prolapse symptom (prevalence and bother) questionnaire.
timeFrame: Pre-operative compared to 12 months post-operative
Secondary outcomes:
measure: Pelvic floor muscle strength.
timeFrame: Pre-operative compared to 12 months post-operative
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: School of Physiotherapy, The University of Melbourne
state: Victoria
Study officials:
affiliation: The University of Melbourne, Australia
name: Mary P Galea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.