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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Immediate 		Patients will be given up to 30 minutes to void during the active void trial postoperatively.
  • Other: Time
    Patients will be given up to 30 minutes to void.
Experimental
Extended 		Patients will be given up to 60 minutes to void during the active void trial postoperatively.
  • Other: Time
    Patients will be given up to 60 minutes to void.

Recruiting Locations

More Details

NCT ID
NCT05885958
Status
Active, not recruiting
Sponsor
University of South Florida

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center