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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Retention Postoperative

Intervention / Treatment
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* Behavioral: No Strict need to void following surgery
* Behavioral: Strict need to void following surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No strict need to void following surgery before discharge<br>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<br>* Certain patient will be randomized without a strict need to void prior to discharge following surgery.<br>|
| Placebo Comparator: Strict need to void following surgery before discharge<br>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<br>* Certain patient will be randomized with a strict need to void prior to discharge following surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of urinary retention | Will measure rates of urinary retention. | 2 years | 
| Rates of UTI | Will measure rates of UTI. | 2 years | 
| Rates of re-presentation to the ER | Will measure rates of re-presentation to ER. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of time spent in PACU | This will assess the amount of time spent (in hours) in PACU. | 2 years | 
| Cost of stay in PACU | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally invasive hysterectomy, Urinary retention, Some day discharge