The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Vaginal Hysterectomy, Pelvic Organ Prolapse Vaginal Surgery

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training and lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair Exclusion Criteria: surgery for malignancy anti-incontinence surgery laparotomy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic floor muscle training<br>Pelvic floor muscle training: clinic and rooms exercise training | Behavioral: Pelvic floor muscle training and lifestyle modification<br> <br> |
| No Intervention: Usual care<br>Usual care as provided by the surgeon and hospital staff | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength. | Strength assessed via digital muscle testing | Pre-operative compared to 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy, Prolapse, Pelvic floor muscles, Bladder, Bowel