Back to resultsPostoperative Active Recovery
Primary Purpose
Pelvic Floor Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Active Recovery
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Floor Disorders
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 89 Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures. Have access to reliable email for communication and questionnaires. Exclusion Criteria: Unable to consent Unable to read and complete questionnaires in English Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported) Use a mobility assistance device such as a walker/cane at baseline Balance or stability problems Patients on chronic opioids
Sites / Locations
- OHSURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard of Care
Active Recovery
Arm Description
Participants will receive standard postoperative instructions only
Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises
Outcomes
Primary Outcome Measures
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)
Change in the Short Form Health Survey (SF-36)
The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100
Change in the Patient Health Questionnaire (PHQ-9)
The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)
Change in the Patient Global Impression of Improvement (PGI-I)
The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)
Secondary Outcome Measures
Full Information
NCT ID
NCT05950633
First Posted
July 11, 2023
Last Updated
September 6, 2023
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT05950633
Brief Title
Postoperative Active Recovery
Official Title
Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.
Detailed Description
This is a randomized controlled trial comparing usual care postoperative restrictions and a novel new active recovery program to look at differences in pelvic floor function, patient quality of life, and mental health in between groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard postoperative instructions only
Arm Title
Active Recovery
Arm Type
Active Comparator
Arm Description
Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Participants will receive standard of care postoperative instructions
Intervention Type
Other
Intervention Name(s)
Active Recovery
Intervention Description
Participants will receive instructions to increase their fitness to walking at least 30 minutes a day for 5 days a week following surgery and abdominal and pelvic floor exercises will focus on abdominal wall strengthening and abdominal pressure management, urinary urgency and retention, bowel and constipation management
Primary Outcome Measure Information:
Title
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
Description
The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)
Time Frame
Baseline to 12 weeks post-surgery
Title
Change in the Short Form Health Survey (SF-36)
Description
The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100
Time Frame
Baseline to 12 weeks
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)
Time Frame
Baseline to 12 weeks post-surgery
Title
Change in the Patient Global Impression of Improvement (PGI-I)
Description
The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)
Time Frame
Baseline to 12 weeks post-surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and 89
Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures.
Have access to reliable email for communication and questionnaires.
Exclusion Criteria:
Unable to consent
Unable to read and complete questionnaires in English
Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported)
Use a mobility assistance device such as a walker/cane at baseline
Balance or stability problems
Patients on chronic opioids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Department of Ob/Gyn
Phone
503-494-3666
Email
whru@ohsu.edu
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Women's Health Research Unit
Phone
503-494-3666
Email
whru@ohsu.edu
12. IPD Sharing Statement
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Postoperative Active Recovery
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