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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05885958
Other study ID # STUDY005629
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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