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

Primary Purpose

Urinary Retention Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Strict need to void following surgery
Strict need to void following surgery
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Retention Postoperative focused on measuring Minimally invasive hysterectomy, Urinary retention, Some day discharge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

No strict need to void following surgery before discharge

Strict need to void following surgery before discharge

Arm Description

Participants randomized to this arm will have no strict need to void following surgery before they are discharged.

Participants randomized to this arm will have a strict need to void following surgery before they are discharged.

Outcomes

Primary Outcome Measures

Rates of urinary retention
Will measure rates of urinary retention.
Rates of UTI
Will measure rates of UTI.
Rates of re-presentation to the ER
Will measure rates of re-presentation to ER.

Secondary Outcome Measures

Amount of time spent in PACU
This will assess the amount of time spent (in hours) in PACU.
Cost of stay in PACU
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.

Full Information

First Posted
October 25, 2021
Last Updated
September 7, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05108506
Brief Title
Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy
Official Title
To Void or Not to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy, That is the Question
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative
Keywords
Minimally invasive hysterectomy, Urinary retention, Some day discharge

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No strict need to void following surgery before discharge
Arm Type
Experimental
Arm Description
Participants randomized to this arm will have no strict need to void following surgery before they are discharged.
Arm Title
Strict need to void following surgery before discharge
Arm Type
Placebo Comparator
Arm Description
Participants randomized to this arm will have a strict need to void following surgery before they are discharged.
Intervention Type
Behavioral
Intervention Name(s)
No Strict need to void following surgery
Intervention Description
Certain patient will be randomized without a strict need to void prior to discharge following surgery.
Intervention Type
Behavioral
Intervention Name(s)
Strict need to void following surgery
Intervention Description
Certain patient will be randomized with a strict need to void prior to discharge following surgery.
Primary Outcome Measure Information:
Title
Rates of urinary retention
Description
Will measure rates of urinary retention.
Time Frame
2 years
Title
Rates of UTI
Description
Will measure rates of UTI.
Time Frame
2 years
Title
Rates of re-presentation to the ER
Description
Will measure rates of re-presentation to ER.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Amount of time spent in PACU
Description
This will assess the amount of time spent (in hours) in PACU.
Time Frame
2 years
Title
Cost of stay in PACU
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja S Frost, MD
Phone
410-458-1977
Email
afrost6@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Patzkowsky
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Frost, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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