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

Quality of Life Clinical Trial

— PT and QOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403701
• Other study ID #: 09015-09-020
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: February 17, 2014
• Start date: July 2009
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Floor Distress and Impact Scores
• Quality of Life
• Sexual Function Scores

Intervention

Behavioral:
• Physical therapy
pelvic floor physical therapy

Locations

Country	Name	City	State
United States	TriHealth, Inc	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;	based on validated indices of sexual function	3-6 months	No