Patient Removal of Catheters After Urogynecologic Surgery

NCT ID: NCT04783012

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-09-09

Brief Summary

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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

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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.

Conditions

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Urinary Retention Postoperative Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home removal of catheter after surgery

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 Type EXPERIMENTAL

Catheter removal

Intervention Type PROCEDURE

Catheter management strategy after surgery

Office removal of catheter after surgery

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.

Group Type ACTIVE_COMPARATOR

Catheter removal

Intervention Type PROCEDURE

Catheter management strategy after surgery

Interventions

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Catheter removal

Catheter management strategy after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ijeoma Agu, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Jennifer M Wu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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UNC Hillsborough Hospital

Hillsborough, North Carolina, United States

Site Status

UNC Rex Hospital

Raleigh, North Carolina, United States

Site Status

Countries

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United States

References

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Askew AL, Margulies SL, Agu I, LeCroy KM, Geller E, Wu JM. Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2024 Feb 1;143(2):165-172. doi: 10.1097/AOG.0000000000005454. Epub 2023 Nov 14.

Reference Type DERIVED
PMID: 37963385 (View on PubMed)

Other Identifiers

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20-3376

Identifier Type: -

Identifier Source: org_study_id

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