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

• Sponsor: TriHealth Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01403701
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

1. 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.

2. 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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Pelvic Floor Distress and Impact Scores; Sexual Function Scores	Behavioral: Physical therapy	N/A

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
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care; [3-6 months]

   based on validated indices of sexual function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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:

• 1. Use of mesh/graft material during the prolapse repair
• 1. Abdominal or laparoscopic prolapse repair

• iii.Current genitourinary fistula or urethral diverticulum

• 1. Contraindication to surgery
• 1. Unable to comply with physical therapy or office visits
• 1. Preexisting neurological condition

• vii.Concurrent surgery for fecal incontinence

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TriHealth, Inc	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• TriHealth Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TriHealth Inc.
• ClinicalTrials.gov Identifier: NCT01403701
• Other Study ID Numbers: 09015-09-020
• First Posted: Jul 27, 2011
• Last Update Posted: Feb 19, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by TriHealth Inc.: physical therapy; pelvic prolapse; incontinence; quality of life

Study Results

No Results Posted as of Feb 19, 2014