Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04495699
Status:
RECRUITING
Last Update Posted:
2023-07-24
First Post:
2020-07-28
Brief Title:
Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Treatment of Asymptomatic Renal Calculi in Recurrent UTIs a Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
None
Brief Summary:
This study will assess patients who have recurrent urinary tract infections and kidney stones which are not blocking the kidney or causing other problems Currently we dont know if taking out these stones will improve recurrent urinary tract infections or not Patients will make a decision with their surgeon about removing or monitoring their stones Whether or not their infections continue with surgery or monitoring will be noted and this information may help to inform future treatment decisions The purpose of this study is to assess if treatment of these asymptomatic stones affects the rate of recurrent urinary tract infections
Detailed Description:
Urinary tract infections UTIs are common and have a large burden of disease at the population level This study will assess the effectiveness of removing kidney stones in patients who have recurrent UTIs
The role of upper urinary tract calculi in UTIs is not well understood Although there is some evidence that some metabolic stones such as calcium oxalate can harbor bacteria it is not known if this is clinically significant or if these contribute to clinical infections
This study aims to advance the level of evidence in the treatment of non-obstructing urolithiasis in the context of recurrent UTIs
The aim of this study is to
1 Assess the effects of treatment of non-obstructing upper urinary tract calculi on recurrent UTIs in the first prospective observational trial in this area
Patients who meet inclusion criteria will make a decision about treating their asymptomatic stones or not with their surgeon as per usual clinical care The primary outcome will be the rate of recurrent urinary tract infections for patients comparing patients who did and did not have their stones treated
Patient data is securely stored in de-identified fashion in REDCAP database following all the secure protocols of the institutions involved The recruitment goal is 80 patients based on power calculations to detect the effect size Statistical analysis will be performed between the two groups with t-test used for normally distributed numerical data and fishers exact or chi-square tests for categorical data
The role of upper urinary tract calculi in UTIs is not well understood Although there is some evidence that some metabolic stones such as calcium oxalate can harbor bacteria it is not known if this is clinically significant or if these contribute to clinical infections
This study aims to advance the level of evidence in the treatment of non-obstructing urolithiasis in the context of recurrent UTIs
The aim of this study is to
1 Assess the effects of treatment of non-obstructing upper urinary tract calculi on recurrent UTIs in the first prospective observational trial in this area
Patients who meet inclusion criteria will make a decision about treating their asymptomatic stones or not with their surgeon as per usual clinical care The primary outcome will be the rate of recurrent urinary tract infections for patients comparing patients who did and did not have their stones treated
Patient data is securely stored in de-identified fashion in REDCAP database following all the secure protocols of the institutions involved The recruitment goal is 80 patients based on power calculations to detect the effect size Statistical analysis will be performed between the two groups with t-test used for normally distributed numerical data and fishers exact or chi-square tests for categorical data
Study Oversight
Has Oversight DMC:
None
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?:
None