Timing of Active Void Trials After Urogynecologic Procedures

June 26, 2025 updated by: Simone Fertel, University of South Florida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • USF Urogynecology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Time
Patients will be given up to 60 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 30 minutes to void.
Other: Time
Patients will be given up to 60 minutes to void.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pass Rate
Time Frame: 60 minutes
to compare the active void trial pass rate between arms
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in PACU
Time Frame: 6 hours
to compare overall time spent in the PACU between arms
6 hours
UTI
Time Frame: 2 weeks
to assess rate of urinary tract infection after surgery
2 weeks
Pass Rate After Failing
Time Frame: 60 minutes
to assess the overall pass rate of active void trial after failed first attempt
60 minutes
Surgical Procedures Performed Prior to Active Void Trial
Time Frame: 2 years
to compare types of surgery women are having with the rate of void trial passing
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

August 27, 2024

Study Completion (Actual)

June 5, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY005629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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