Loading clinical trials...
Loading clinical trials...
Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Women & Infants Hospital
Providence, Rhode Island, United States
Start Date
September 10, 2018
Primary Completion Date
May 10, 2021
Completion Date
December 30, 2021
Last Updated
July 20, 2021
183
ACTUAL participants
PVR-based self-catheterization
PROCEDURE
Lead Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
NCT04597372
NCT07174349
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06344884