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OpenTrials
Completed

NCT Number: NCT05885958

Timing of Active Void Trials After Urogynecologic Procedures

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.

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Key information

Conditions

Postoperative Care Urinary Catheters Urogynecology

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USF Urogynecology Clinic

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TIME

Other

Patients will be given up to 30 minutes to void.

Primary outcomes

  1. Pass Rate

    Time frame: 60 minutes

    to compare the active void trial pass rate between arms

Secondary outcomes

  1. Time in PACU

    Time frame: 6 hours

    to compare overall time spent in the PACU between arms

  2. Pass Rate After Failing

    Time frame: 60 minutes

    to assess the overall pass rate of active void trial after failed first attempt

  3. UTI

    Time frame: 2 weeks

    to assess rate of urinary tract infection after surgery

  4. 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

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 2, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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