Clinical trial NCT01403701: Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery
Official title: Effects of Physical Therapy on Quality of Life and Function Following Vaginal Reconstructive Surgery; a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Pelvic Floor Distress and Impact Scores
Sexual Function Scores
Keywords: physical therapy
pelvic prolapse
incontinence
quality of life
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 3-6 months
Secondary outcomes:
measure: 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
timeFrame: 3-6 months
measure: Comparing sexual function scores in participants undergoing physical therapy compared to standard postoperative care;
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth, Inc
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Rachel N Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References: