Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 8:37 AM
Study NCT ID:
NCT04010656
Status:
UNKNOWN
Last Update Posted:
2021-07-20
First Post:
2019-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Spontaneous Postoperative Trial of Void Among Women
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Study Overview
Official Title:
Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTION
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: