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

Not Applicable

Completed

• Conditions: Quality of Life; Pelvic Floor Distress and Impact Scores; Sexual Function Scores
• Interventions: Behavioral: Physical therapy

• Registration Number: NCT01403701
• Lead Sponsor: TriHealth Inc.

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:

1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care

2. Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care;

3. Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care;

4. 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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical therapy	Physical therapy	Standardized pelvic floor physical therapy

Primary Outcome Measures

Name	Time	Method
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	3-6 months	Quality of life scores on the world health organization validated quality of life scale

Secondary Outcome Measures

Name	Time	Method
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	several validated indices for measuring symptoms of urinary and bowel symptoms
Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;	3-6 months	based on validated indices of sexual function

Trial Locations

Locations (1)

TriHealth, Inc; 🇺🇸 Cincinnati, Ohio, United States