NCT04010656

Optimization of Spontaneous Postoperative Trial of Void Among Women

Optimization of Spontaneous Trial of Void: a Prospective Cohort Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.

Detailed description

Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume \[MVV\], post-void residual via bladder scanner \[PVR\], subjective force of urinary stream \[sFOS\]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.

Conditions

• Urinary Retention Postoperative
• Voiding Disorders

Interventions

Type	Name	Description
PROCEDURE	PVR-based self-catheterization	Home self-catheterization based on standard of care

Timeline

• Start date: 2018-09-10
• Primary completion: 2021-05-10
• Completion: 2021-12-30
• First posted: 2019-07-08
• Last updated: 2021-07-20

Locations

1 site across 1 country: United States