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

This study is currently recruiting participants.
Verified December 2012 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
Rachel N. Pauls, TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01403701
First received: July 21, 2011
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.

Condition Intervention
Quality of Life
Pelvic Floor Distress and Impact Scores
Sexual Function Scores
 Behavioral: Physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Quality of life scores on the world health organization validated quality of life scale


Secondary Outcome Measures:
  • 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 [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    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; [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    based on validated indices of sexual function


Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical therapy
Standardized pelvic floor physical therapy
 Behavioral: Physical therapy
pelvic floor physical therapy
No Intervention: routine care
Standard postoperative visits

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403701

Locations
United States, Ohio
TriHealth, Inc Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Vivian Ghodsi, RN     513-463-4308        
Contact: Angie Fellner, PhD     513-862-1400        
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Rachel N Pauls, MD TriHealth Inc.
  More Information

No publications provided

Responsible Party: Rachel N. Pauls, Director of Research, Division of Urogynecology, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01403701     History of Changes
Other Study ID Numbers: 09015-09-020
Study First Received: July 21, 2011
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013