Clinical trial NCT05885958: Timing of Active Void Trials After Urogynecologic Procedures
Official title: Timing of Active Void Trials After Urogynecologic Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Care
Urinary Catheters
Urogynecology
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Pass Rate
timeFrame: 60 minutes
Secondary outcomes:
measure: Time in PACU
timeFrame: 6 hours
measure: Pass Rate After Failing
timeFrame: 60 minutes
measure: UTI
timeFrame: 2 weeks
measure: Surgical Procedures Performed Prior to Active Void Trial
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Urogynecology Clinic
state: Florida
Study officials:
References:
citation: Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery - E-Book: Elsevier Health Sciences; 2021
citation: Lo TS, Shailaja N, Hsieh WC, Uy-Patrimonio MC, Yusoff FM, Ibrahim R. Predictors of voiding dysfunction following extensive vaginal pelvic reconstructive surgery. Int Urogynecol J. 2017 Apr;28(4):575-582. doi: 10.1007/s00192-016-3144-z. Epub 2016 Sep 19.
citation: Kim JW, Moon du G, Shin JH, Bae JH, Lee JG, Oh MM. Predictors of Voiding Dysfunction after Mid-urethral Sling Surgery for Stress Urinary Incontinence. Int Neurourol J. 2012 Mar;16(1):30-6. doi: 10.5213/inj.2012.16.1.30. Epub 2012 Mar 31.
citation: Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, Krupski TL. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial. World J Urol. 2020 Sep;38(9):2247-2252. doi: 10.1007/s00345-019-03005-0. Epub 2019 Nov 15.
citation: Wang R, Won S, Haviland MJ, Von Bargen E, Hacker MR, Li J, Lefevre R. Voiding trial outcome following pelvic floor repair without incontinence procedures. Int Urogynecol J. 2016 Aug;27(8):1215-20. doi: 10.1007/s00192-016-2975-y. Epub 2016 Feb 17.
citation: Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.