Pelvic Floor Disorders
Conditions
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.
Interventions
OTHERStandard of Care
Participants will receive standard of care postoperative instructions
OTHERActive 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
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Between the ages of 18 and 89 2. 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. 3. Have access to reliable email for communication and questionnaires.
Exclusion criteria
1. Unable to consent 2. Unable to read and complete questionnaires in English 3. Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported) 4. Use a mobility assistance device such as a walker/cane at baseline 5. Balance or stability problems 6. Patients on chronic opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed