Postoperative Active Recovery
Study Details
Study Description
Brief Summary
This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of Care Participants will receive standard postoperative instructions only |
Other: Standard of Care
Participants will receive standard of care postoperative instructions
|
| Active Comparator: Active Recovery Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises |
Other: Active Recovery
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
|
Outcome Measures
Primary Outcome Measures
- Change in the Pelvic Floor Distress Inventory-20 (PFDI-20) [Baseline to 12 weeks post-surgery]
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) [Baseline to 12 weeks]
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) [Baseline to 12 weeks post-surgery]
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) [Baseline to 12 weeks post-surgery]
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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OHSU IRB 25625