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Active Recovery Program for Post-Surgery Recovery of Pelvic Surgery
N/A
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
Summary
This trial evaluates a new post-surgery recovery program to help people heal faster after pelvic surgery.
Who is the study for?
This trial is for individuals aged 18-89 who are undergoing minimally invasive surgery for pelvic floor dysfunction at OHSU. Participants must be able to walk or be active for 30 minutes, not use chronic opioids or mobility aids like walkers, and must have email access.Check my eligibility
What is being tested?
The study compares the standard postoperative care with a new 'active recovery' program after pelvic reconstructive surgery. The goal is to evaluate if this new program improves recovery outcomes.See study design
What are the potential side effects?
Since the trial involves standard care and an active recovery program, side effects may include typical post-surgical discomforts such as pain, fatigue, and potential complications from increased activity soon after surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Patient Global Impression of Improvement (PGI-I)
Change in the Patient Health Questionnaire (PHQ-9)
Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
Participants will receive standard postoperative instructions only
Group II: Active RecoveryActive Control1 Intervention
Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
985 Previous Clinical Trials
7,385,644 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 89 years old.I am having a minimally invasive surgery for pelvic organ prolapse at OHSU.I am unable to give consent by myself.I cannot walk or be active for 30 minutes without stopping.I have a reliable email for communication.I use a walker or cane to help me move around.I have issues with balance or feeling stable.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Active Recovery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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