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Patient Removal of Catheters After Urogynecologic Surgery (CARES Trial)
N/A
Waitlist Available
Led By Amy L Askew, MD, MPH
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 2-5 days postoperatively
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether patients can remove their own indwelling catheters at home, which is less invasive than having them removed in a medical office.
Eligible Conditions
- Urinary Retention
- Patient Satisfaction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-5 days postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-5 days postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Risk of Urinary Retention in the Early Postoperative Period
Secondary study objectives
Number of nursing calls and office visits for urinary issues in the six week postoperative period
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: Home removal of catheter after surgeryExperimental Treatment1 Intervention
Patients randomized to home removal will be assigned to remove their catheters on postoperative day (POD) 2 (or if Th/F surgery, POD 4 or POD 3, respectively). They will be handed an instructional packed with visual, written and video instructions for catheter removal.
Group II: Office removal of catheter after surgeryActive Control1 Intervention
Patients randomized to office removal will be assigned to return to the office on POD 2 (or if Th/F surgery, POD 4 or POD 3, respectively) for standard nurse visit with backfill, catheter removal and voiding trial in the office.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Catheter removal
2021
N/A
~120
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,564 Previous Clinical Trials
4,301,267 Total Patients Enrolled
Amy L Askew, MD, MPHPrincipal InvestigatorUNC Chapel Hill
Ijeoma Agu, MDPrincipal InvestigatorUNC Chapel Hill
Jennifer M Wu, MD, MPHPrincipal InvestigatorUNC Chapel Hill