Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery (PT and QOL)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pelvic Floor Distress and Impact Scores; Sexual Function Scores
• Intervention / Treatment: Behavioral: Physical therapy

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical therapy; Standardized pelvic floor physical therapy	Behavioral: Physical therapy; pelvic floor physical therapy
No Intervention: routine care; Standard postoperative visits

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Rachel N Pauls, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; physical therapy; incontinence; pelvic prolapse
• Other Study ID Numbers: 09015-09-020