Postoperative Active Recovery

Oregon Health and Science University72 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pelvic Floor Disorders

Interventions

Standard of CareOTHER

Participants will receive standard of care postoperative instructions

Active RecoveryOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

OHSU

Portland, Oregon, United States

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: Baseline to 12 weeks post-surgery

Data from ClinicalTrials.gov

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