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

Urinary Retention Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108506
• Other study ID #: IRB00307084
• Status: Completed
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention
• Urinary Retention Postoperative

Intervention

Behavioral:
• No Strict need to void following surgery
Certain patient will be randomized without a strict need to void prior to discharge following surgery.
• Strict need to void following surgery
Certain patient will be randomized with a strict need to void prior to discharge following surgery.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of urinary retention	Will measure rates of urinary retention.	2 years
Primary	Rates of UTI	Will measure rates of UTI.	2 years
Primary	Rates of re-presentation to the ER	Will measure rates of re-presentation to ER.	2 years
Secondary	Amount of time spent in PACU	This will assess the amount of time spent (in hours) in PACU.	2 years
Secondary	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.	2 years