Timing of Active Void Trials After Urogynecologic Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2025-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

NCT03048682

Pelvic Organ Prolapse Urinary Incontinence,Stress Surgery

COMPLETED NA

Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention

NCT02886143

Urinary Retention Urinary Tract Infections

COMPLETED PHASE3

Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

NCT05820139

Voiding Dysfunction

COMPLETED NA

Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery

NCT03539107

Urinary Incontinence Pelvic Organ Prolapse

COMPLETED NA

Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

NCT01091844

Urinary Retention Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Care Urinary Catheters Urogynecology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate

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

Group Type EXPERIMENTAL

Time

Intervention Type OTHER

Patients will be given up to 30 minutes to void.

Extended

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

Group Type EXPERIMENTAL

Time

Intervention Type OTHER

Patients will be given up to 60 minutes to void.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Time

Patients will be given up to 30 minutes to void.

Intervention Type OTHER

Time

Patients will be given up to 60 minutes to void.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No