Timing of Active Void Trials After Urogynecologic Procedures

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery. Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.

Official Title
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Timing of Active Void Trials After Urogynecologic Procedures

Conditions
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Postoperative Care, Urinary Catheters, Urogynecology

Intervention / Treatment
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* Other: Time
* Other: Time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated Planned for same day surgery Women able to consent for themselves Speak English and/or Spanish as preferred language Exclusion Criteria: Imprisoned patients Females under the age of 18 years old Women who are unable or unwilling to consent to participation Women who are planning to stay inpatient overnight Women with history of urinary retention or neurogenic bladder Women undergoing procedure that is not standard of care to perform a void trial (includes sacral neuromodulation, botox to the pelvic floor, cystoscopy with hydrodistension, urethral bulking, etc)

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate<br>Patients will be given up to 30 minutes to void during the active void trial postoperatively. | Other: Time<br>* Patients will be given up to 30 minutes to void.<br>|
| Experimental: Extended<br>Patients will be given up to 60 minutes to void during the active void trial postoperatively. | Other: Time<br>* Patients will be given up to 60 minutes to void.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pass Rate | to compare the active void trial pass rate between arms | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in PACU | to compare overall time spent in the PACU between arms | 6 hours | 
| Pass Rate After Failing | to assess the overall pass rate of active void trial after failed first attempt | 60 minutes | 
| UTI | to assess rate of urinary tract infection after surgery | 2 weeks | 
| Surgical Procedures Performed Prior to Active Void Trial | to compare types of surgery women are having with the rate of void trial passing | 2 years |