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Early Catheter Removal for Urogynecologic Surgery (CARES2 Trial)

N/A
Recruiting
Led By Lauren Tholemeier, MD
Research Sponsored by University of North Carolina, Chapel Hill
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 from postoperative day 1 through postoperative week 8
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if patients can remove their catheters at home on the first day after surgery instead of waiting until the third or fourth day. The study is comparing the outcomes of early catheter

Who is the study for?
This trial is for women who have had prolapse or anti-incontinence surgery and can't empty their bladder properly before leaving the hospital. It's not for those who don't speak English, are pregnant, needed catheterization before surgery, got urethral injections, or had complications during surgery needing longer catheter use.
What is being tested?
The study tests if patients removing urinary catheters at home one day after urogynecologic surgery is just as good as the standard practice of removal on days three or four by a healthcare provider in an office setting.
What are the potential side effects?
Potential side effects may include discomfort where the catheter was placed, increased risk of urinary tract infections due to earlier removal at home, and possible issues with retaining urine after early removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from postoperative day 1 through postoperative week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and from postoperative day 1 through postoperative week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with ongoing urinary retention (noninferiority)
Secondary study objectives
Number of patient contacts for voiding dysfunction by Type
Number of patients treated for postoperative UTI.
Number of patients with ongoing urinary retention
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Catheter RemovalExperimental Treatment1 Intervention
Participants in this arm will be asked to remove their catheters POD1.
Group II: Standard Catheter RemovalActive Control1 Intervention
Participants in this arm will be asked to remove their catheters POD3-4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early catheter removal
2017
N/A
~60

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,441 Total Patients Enrolled
Lauren Tholemeier, MDPrincipal InvestigatorUniversity of North Carollina at Chapel Hill
~75 spots leftby Jul 2025
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