Postoperative Active Recovery

Not Applicable

Active, not recruiting

• Conditions: Pelvic Floor Disorders
• Interventions: Other: Active Recovery; Other: Standard of Care

• Registration Number: NCT05950633
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-18
• Study Start: 2023-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Recovery	Active Recovery	Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises
Standard of Care	Standard of Care	Participants will receive standard postoperative instructions only

Primary Outcome Measures

Name	Time	Method
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 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 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)

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States