NCT05820139

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

A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events

Detailed description

Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.

Conditions

• Voiding Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Control Group	Patients will be randomized to a 200mL (control group)
PROCEDURE	Test Group	Patients will be randomized to a cut-off of 150mL (test group)

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2023-04-19
• Last updated: 2024-04-29

Locations

1 site across 1 country: United States