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

NCT05108506 | Completed

• 1 other identifier: IRB00307084
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention Postoperative

Keywords

Minimally invasive hysterectomy; Urinary retention; Some day discharge

Outcome Measures

Primary Outcomes (1)

• Amount of time spent in PACU

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

  2 years

Secondary Outcomes (4)

• Rates of urinary retention

  2 years

• Rates of UTI

  2 years

• Rates of re-presentation to the ER

  2 years

• Cost of stay in PACU

  2 years

Study Arms (2)

No strict need to void following surgery before discharge

EXPERIMENTAL

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

Strict need to void following surgery before discharge

PLACEBO COMPARATOR

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

Interventions

No Strict need to void following surgery BEHAVIORAL

Certain patient will be randomized without a strict need to void prior to discharge following surgery.

No strict need to void following surgery before discharge

Strict need to void following surgery BEHAVIORAL

Certain patient will be randomized with a strict need to void prior to discharge following surgery.

Strict need to void following surgery before discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kristin Patzkowsky

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: December 5, 2022
• Primary Completion: March 30, 2024
• Study Completion: April 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)