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OpenTrials
Completed

NCT Number: NCT05108506

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

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.

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Key information

Conditions

Urinary Retention Postoperative Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Strict need to void following surgery

Behavioral

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

Strict need to void following surgery

Behavioral

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

Primary outcomes

  1. Amount of time spent in PACU

    Time frame: 2 years

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

Secondary outcomes

  1. Rates of urinary retention

    Time frame: 2 years

    Will measure rates of urinary retention.

  2. Rates of UTI

    Time frame: 2 years

    Will measure rates of UTI.

  3. Rates of re-presentation to the ER

    Time frame: 2 years

    Will measure rates of re-presentation to ER.

  4. Cost of stay in PACU

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2021
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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