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

Not Applicable

Completed

• Conditions: Urinary Retention Postoperative
• Interventions: Behavioral: Strict need to void following surgery; Behavioral: No Strict need to void following surgery

• Registration Number: NCT05108506
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-05
• Study Start: 2022-12-05
• Primary Completion: 2024-03-30
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Strict need to void following surgery before discharge	Strict need to void following surgery	Participants randomized to this arm will have a strict need to void following surgery before they are discharged.
No strict need to void following surgery before discharge	No Strict need to void following surgery	Participants randomized to this arm will have no strict need to void following surgery before they are discharged.

Primary Outcome Measures

Name	Time	Method
Amount of time spent in PACU	2 years	This will assess the amount of time spent (in hours) in PACU.

Secondary Outcome Measures

Name	Time	Method
Rates of urinary retention	2 years	Will measure rates of urinary retention.
Rates of UTI	2 years	Will measure rates of UTI.
Rates of re-presentation to the ER	2 years	Will measure rates of re-presentation to ER.
Cost of stay in PACU	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.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States