An observational study in Urinary Tract Infections and Kidney Stone, sponsored by Vanderbilt University Medical Center. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-21.
Sponsored by Vanderbilt University Medical Center · Observational
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 don't 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 stone(s). 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.
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 fisher's exact or chi-square tests for categorical data.
753 studies on the registry are indexed under Urinary Tract Infections; 127 are open to participants now.
This study's enrollment of 94 is below the median of 200 across 188 observational studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with recurrent UTIs and asymptomatic renal calculi.
Exclusion Criteria:
Patients who elect to have observation of their asymptomatic stones as part of usual care will be followed. Note that there is no randomization, the decision to treat or not treat a stone is made in the usual clinical fashion by the patient in consultation with their surgeon.
Patients who elect to have intervention of their asymptomatic stones as part of usual care will be followed. Note that there is no randomization, the decision to treat or not treat a stone is made in the usual clinical fashion by the patient in consultation with their surgeon.
Other: None - observational
If the patient elects to have their stone treated, it will be treated in the usual most clinically appropriate fashion (Shockwave lithotripsy, ureteroscopy, or percutaneous nephrolithotomy). All types of treatment will be analyzed together.
Recurrent urinary tract infections
• Number of UTIs, defined as positive urine culture (\>10\^5 CFU/mL of a specific organism) with symptoms. If having had surgical intervention for the stones, we will count a UTI during \>30days and \<1year after intervention so that it is not attributed to the intervention
Time frame: 12 months
Time to first UTI
Time from first visit to first UTI, defined as above
Time frame: up to 12 months
Pyelonephritis/urosepsis
Incidence of pyelonephritis/urosepsis
Time frame: up to 12 months
Incidence of complications from intervention within 30 days
Clavien-Dindo complications, ER visits, readmissions, infections within 30 days, non-elective repeat interventions (eg for obstructing fragments)
Time frame: 30 days
Incidence of further intervention for stones
any further stone interventions required
Time frame: 12 months
Stone analysis correlation with rUTI
Correlation between primary outcome and stone analysis
Time frame: 12 months
Stone free vs not stone free correlation with rUTI
Correlation between stone free status after intervention and recurrent UTI
Time frame: 12 months
Correlation of selected demographic factors with rUTI
Correlation between baseline demographic parameters and recurrent UTIs (including include age, sex, bacteria type, previous sequelae from UTIs, previous sequelae from stones, comorbidities including diabetes mellitus, obesity, hypertension, and immunosuppression, creatinine, total stone burden, location of stones, stone composition, stone culture, post-intervention stone free rate, and 24-h urine parameters if available)
Time frame: 12 months
Number free from recurrent UTIs
Number patients free of recurrent UTIs at 1 year, defined as 3 positive urine cultures (\>105 CFU/mL of a specific organism) with symptoms in 1 year, or 2 in 6 months. If having had surgical intervention for the stones, we will count a UTI during \>30days and \<1year after intervention so that it is not attributed to the intervention
Time frame: 12 months
Number free from any UTI
Number of patients free from any UTI at one year, as defined above
Time frame: 12 months
Crossover from observation to intervention
Patients on observation and decide to seek treatment after enrollment
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center