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

NCT ID: NCT01403701

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-06-30

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. 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical therapy

Standardized pelvic floor physical therapy

Group Type: EXPERIMENTAL

Physical therapy

Intervention Type: BEHAVIORAL

pelvic floor physical therapy

routine care

Standard postoperative visits

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical therapy

pelvic floor physical therapy

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel N Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

TriHealth, Inc

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

09015-09-020

Identifier Type: -

Identifier Source: org_study_id