NCT05885958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 3, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

May 22, 2023

Last Update Submit

June 26, 2025

Conditions

Postoperative CareUrinary CathetersUrogynecology

Outcome Measures

Primary Outcomes (1)

  • Pass Rate

    to compare the active void trial pass rate between arms

    60 minutes

Secondary Outcomes (4)

  • Time in PACU

    6 hours

  • Pass Rate After Failing

    60 minutes

  • UTI

    2 weeks

  • Surgical Procedures Performed Prior to Active Void Trial

    2 years

Study Arms (2)

Immediate

EXPERIMENTAL

Patients will be given up to 30 minutes to void during the active void trial postoperatively.

Other: Time

Extended

EXPERIMENTAL

Patients will be given up to 60 minutes to void during the active void trial postoperatively.

Other: Time

Interventions

TimeOTHER

Patients will be given up to 30 minutes to void.

Immediate

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USF Urogynecology Clinic

Tampa, Florida, 33606, United States

Location

Related Publications (6)

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

    BACKGROUND

  • 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.

    PMID: 27647467BACKGROUND

  • 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.

    PMID: 22500251BACKGROUND

  • 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.

    PMID: 31732771BACKGROUND

  • 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.

    PMID: 26886553BACKGROUND

  • 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.

    PMID: 26894607BACKGROUND

MeSH Terms

Interventions

Time

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 2, 2023

Study Start

July 3, 2023

Primary Completion

August 27, 2024

Study Completion

June 5, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)