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OpenTrials
Completed

NCT Number: NCT04783012

Patient Removal of Catheters After Urogynecologic Surgery

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.

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Key information

Conditions

Urinary Retention Postoperative Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hillsborough Hospital, Hillsborough, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter removal

Procedure

Catheter management strategy after surgery

Primary outcomes

  1. Risk of Urinary Retention in the Early Postoperative Period

    Time frame: 2-5 days postoperatively

    The percentage of patients who have urinary retention in the early postoperative period (failed voiding trial after discharge POD 2-5) will be measured.

Secondary outcomes

  1. Number of nursing calls and office visits for urinary issues in the six week postoperative period

    Time frame: 6 week postoperative period

    Number of nursing calls and office visits for voiding issues (including catheter issues, voiding dysfunction and urinary retention) will be measured.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: CARES

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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