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

Johns Hopkins University

Status: Completed

Conditions: Urinary Retention Postoperative

Treatments: Behavioral: No Strict need to void following surgery; Behavioral: Strict need to void following surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05108506

IRB00307084

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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205 participants in 2 patient groups, including a placebo group

No strict need to void following surgery before discharge

Experimental group

Description:

Participants randomized to this arm will have no strict need to void following surgery before they are discharged.

Treatment:

Behavioral: No Strict need to void following surgery

Strict need to void following surgery before discharge

Placebo Comparator group

Description:

Participants randomized to this arm will have a strict need to void following surgery before they are discharged.

Treatment:

Behavioral: Strict need to void following surgery