Postoperative Active Recovery

Study Overview
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Brief Summary
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This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.

Detailed Description
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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.

Official Title
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Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial

Conditions
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Pelvic Floor Disorders

Intervention / Treatment
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* Other: Standard of Care
* Other: Active Recovery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Participants will receive standard postoperative instructions only | Other: Standard of Care<br>* Participants will receive standard of care postoperative instructions<br>|
| Active Comparator: Active Recovery<br>Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises | Other: Active Recovery<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline to 12 weeks post-surgery | 
| 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 | Baseline to 12 weeks | 
| 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) | Baseline to 12 weeks post-surgery | 
| 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) | Baseline to 12 weeks post-surgery |