Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery

Study Overview
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Brief Summary
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i) The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence. ii) Secondary objectives include: Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care; Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care; Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.

Detailed Description
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This is a single center randomized controlled trial assessing quality of life in participants following vaginal surgery receiving physical therapy compared to standard postoperative care. Patients will be under care of the physicians of the Division of Urogynecology and Reconstructive Pelvic Surgery. All physicians are board certified, fellowship trained urogynecologists.

Official Title
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Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial

Conditions
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Quality of Life, Pelvic Floor Distress and Impact Scores, Sexual Function Scores

Intervention / Treatment
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* Behavioral: Physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaginal reconstructive surgery for prolapse Age of at least 18 years Willing to comply with physical therapy Exclusion Criteria: i. Use of mesh/graft material during the prolapse repair ii. Abdominal or laparoscopic prolapse repair iii.Current genitourinary fistula or urethral diverticulum iv. Contraindication to surgery v. Unable to comply with physical therapy or office visits vi. Preexisting neurological condition vii.Concurrent surgery for fecal incontinence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical therapy<br>Standardized pelvic floor physical therapy | Behavioral: Physical therapy<br>* pelvic floor physical therapy<br>|
| No Intervention: routine care<br>Standard postoperative visits | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative quality of life as based on the scores of the WHO-QOL Bref in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence | Quality of life scores on the world health organization validated quality of life scale | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing pelvic floor quality of life scores and distress related to pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care | several validated indices for measuring symptoms of urinary and bowel symptoms | 3-6 months | 
| Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care; | based on validated indices of sexual function | 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy, pelvic prolapse, incontinence, quality of life