Timing of Active Void Trials After Urogynecologic Procedures

Not Applicable

Active, not recruiting

• Conditions: Postoperative Care; Urinary Catheters; Urogynecology
• Interventions: Other: Time

• Registration Number: NCT05885958
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-02
• Study Start: 2023-07-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 208

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended	Time	Patients will be given up to 60 minutes to void during the active void trial postoperatively.
Immediate	Time	Patients will be given up to 30 minutes to void during the active void trial postoperatively.

Primary Outcome Measures

Name	Time	Method
Pass Rate	60 minutes	to compare the active void trial pass rate between arms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

USF Urogynecology Clinic; 🇺🇸 Tampa, Florida, United States