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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05108506
Enrollment
205
Registered
2021-11-05
Start date
2022-12-05
Completion date
2024-04-01
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention Postoperative

Keywords

Minimally invasive hysterectomy, Urinary retention, Some day discharge

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.

Interventions

BEHAVIORALNo Strict need to void following surgery

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

BEHAVIORALStrict need to void following surgery

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

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amount of time spent in PACU2 yearsThis will assess the amount of time spent (in hours) in PACU.

Secondary

MeasureTime frameDescription
Rates of urinary retention2 yearsWill measure rates of urinary retention.
Rates of UTI2 yearsWill measure rates of UTI.
Rates of re-presentation to the ER2 yearsWill measure rates of re-presentation to ER.
Cost of stay in PACU2 yearsThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026