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

TriHealth

Status: Completed

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

Treatments: Behavioral: Physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01403701

09015-09-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Physical therapy

Experimental group

Description:

Standardized pelvic floor physical therapy

Treatment:

Behavioral: Physical therapy

routine care

No Intervention group

Description:

Standard postoperative visits