Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy

July 15, 2024 updated by: Johns Hopkins University

To Void or Not to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy, That is the Question

Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.

To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
  • English speaking

Exclusion Criteria:

  • At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
  • Any patient with a history of prior urologic procedures
  • Patients with any baseline known urinary disease
  • Any bladder injury at the time of surgery
  • Any combined cases with other surgical services
  • Patients undergoing surgery for prolapse or incontinence symptoms
  • Patients who are ultimately not discharged the same day and remain in house overnight

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No strict need to void following surgery before discharge
Participants randomized to this arm will have no strict need to void following surgery before they are discharged.
Behavioral: No Strict need to void following surgery
Certain patient will be randomized without a strict need to void prior to discharge following surgery.
Placebo Comparator: Strict need to void following surgery before discharge
Participants randomized to this arm will have a strict need to void following surgery before they are discharged.
Behavioral: Strict need to void following surgery
Certain patient will be randomized with a strict need to void prior to discharge following surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of time spent in PACU
Time Frame: 2 years
This will assess the amount of time spent (in hours) in PACU.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of urinary retention
Time Frame: 2 years
Will measure rates of urinary retention.
2 years
Rates of UTI
Time Frame: 2 years
Will measure rates of UTI.
2 years
Rates of re-presentation to the ER
Time Frame: 2 years
Will measure rates of re-presentation to ER.
2 years
Cost of stay in PACU
Time Frame: 2 years
This will assess the cost pertaining to the time spent in the PACU to determine if the time spent has a significant impact on the cost.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Kristin Patzkowsky, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00307084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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