The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Sponsor

University of Melbourne (Other)

Overall Status

Completed

CT.gov ID

NCT00222326

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Hysterectomy Pelvic Organ Prolapse Vaginal Surgery	Behavioral: Pelvic floor muscle training and lifestyle modification	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pelvic floor muscle training Pelvic floor muscle training: clinic and rooms exercise training	Behavioral: Pelvic floor muscle training and lifestyle modification
No Intervention: Usual care Usual care as provided by the surgeon and hospital staff

Arm

Intervention/Treatment

Experimental: Pelvic floor muscle training

Pelvic floor muscle training: clinic and rooms exercise training

Behavioral: Pelvic floor muscle training and lifestyle modification

No Intervention: Usual care

Usual care as provided by the surgeon and hospital staff

Outcome Measures

Primary Outcome Measures

Bladder symptom (prevalence and bother) questionnaire. [Pre-operative compared to 12 months post-operative]
A questionnaire about bladder symptoms
Prolapse symptom (prevalence and bother) questionnaire. [Pre-operative compared to 12 months post-operative]
A questionnaire about prolapse symptoms