Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TriHealth Inc.
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Time Frame: 3-6 months
Quality of life scores on the world health organization validated quality of life scale
Secondary Outcomes
- 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(3-6 months)
- Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;(3-6 months)