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Patient Removal of Catheters After Urogynecologic Surgery

Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Non-Inferiority Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04783012
Acronym
CARES
Enrollment
120
Registered
2021-03-04
Start date
2021-02-15
Completion date
2022-09-09
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction, Urinary Retention Postoperative

Brief summary

Management of postoperative urinary retention often requires the use of indwelling catheters. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Detailed description

Voiding trials are a routine part of Urogynecologic surgery. Management of postoperative urinary retention often requires the use of indwelling catheters. However, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. Many Urology practices allow patient removal of catheters after procedures, though this has not been formally studied. The purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Interventions

PROCEDURECatheter removal

Catheter management strategy after surgery

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge * 18+ years old

Exclusion criteria

* Non-English speaking * Pregnant * Elevated PVR (\>150 mL) or dependent upon catheterization to void pre-operatively * Urethral bulking injection surgery * Intra-operative complication requiring prolonged catheterization * Unable or unwilling to remove catheter at home

Design outcomes

Primary

MeasureTime frameDescription
Risk of Urinary Retention in the Early Postoperative Period2-5 days postoperativelyThe percentage of patients who have urinary retention in the early postoperative period (failed voiding trial after discharge POD 2-5) will be measured.

Secondary

MeasureTime frameDescription
Number of nursing calls and office visits for urinary issues in the six week postoperative period6 week postoperative periodNumber of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026