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Completed

NCT Number: NCT01403701

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

TriHealth, Inc

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Behavioral

pelvic floor physical therapy

Primary outcomes

  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

    Time frame: 3-6 months

    Quality of life scores on the world health organization validated quality of life scale

Secondary outcomes

  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

    Time frame: 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;

    Time frame: 3-6 months

    based on validated indices of sexual function

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Acronym: PT and QOL

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jul 27, 2011
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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