Timing of Active Void Trials After Urogynecologic Procedures

Postoperative Care Clinical Trial

Official title:

Timing of Active Void Trials After Urogynecologic Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885958
• Other study ID #: STUDY005629
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: University of South Florida
• Contact: Simone Fertel, MD
• Phone: 5049313383
• Email: sfertel[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Care
• Urinary Catheters
• Urogynecology

Intervention

Other:
• Time
Patients will be given up to 30 minutes to void.
• Time
Patients will be given up to 60 minutes to void.

Locations

Country	Name	City	State
United States	USF Urogynecology Clinic	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery - E-Book: Elsevier Health Sciences; 2021

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pass Rate	to compare the active void trial pass rate between arms	60 minutes
Secondary	Time in PACU	to compare overall time spent in the PACU between arms	6 hours
Secondary	Pass Rate After Failing	to assess the overall pass rate of active void trial after failed first attempt	60 minutes
Secondary	UTI	to assess rate of urinary tract infection after surgery	2 weeks
Secondary	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