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

NCT01403701 | Completed

• 1 other identifier: 09015-09-020
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 1.Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
2. 2.Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care;
3. 3.Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care;
4. 4.Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.

Conditions

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

Keywords

physical therapy; pelvic prolapse; incontinence; quality of life

Outcome Measures

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

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

  3-6 months

Secondary Outcomes (2)

• 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

• Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;

  3-6 months

Study Arms (2)

Physical therapy

EXPERIMENTAL

Standardized pelvic floor physical therapy

Behavioral: Physical therapy

routine care

NO INTERVENTION

Standard postoperative visits

Interventions

Physical therapy BEHAVIORAL

pelvic floor physical therapy

Physical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Vaginal reconstructive surgery for prolapse
• Age of at least 18 years
• Willing to comply with physical therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth, Inc

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Rachel N Pauls, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

US (1)