Kidney Stone, Urinary Tract Infections
Conditions
Keywords
Urinary Tract Infection, Kidney Stones, Urolithiasis
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 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.
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 fisher's exact or chi-square tests for categorical data.
Interventions
OTHERNone - 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.
Sponsors
University of British Columbia
University of California, San Diego
Mayo Clinic
Massachusetts General Hospital
Columbia University
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(all of the following): * recurrent UTIs, defined as 3 positive urine cultures of specific organisms with symptoms within 12 months (or 2 positive cultures with symptoms within 6 months) prior to clinical assessment * non-obstructing renal stone(s) on imaging within 6 months of initial visit
Exclusion criteria
* age \< 18 years * pregnancy * hydronephrosis or evidence of obstruction * presence of a foreign body in urinary tract (e.g. Foley, ureteral stent, nephrostomy tube) at the time of UTI diagnosis * concurrent bladder calculi * Urinary diversion or previous surgery involving segments of bowel interposed into the urinary tract (ileal conduit, ileal ureter etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent urinary tract infections | 12 months | • 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pyelonephritis/urosepsis | up to 12 months | Incidence of pyelonephritis/urosepsis |
| Incidence of complications from intervention within 30 days | 30 days | Clavien-Dindo complications, ER visits, readmissions, infections within 30 days, non-elective repeat interventions (eg for obstructing fragments) |
| Incidence of further intervention for stones | 12 months | any further stone interventions required |
| Stone analysis correlation with rUTI | 12 months | Correlation between primary outcome and stone analysis |
| Time to first UTI | up to 12 months | Time from first visit to first UTI, defined as above |
| Correlation of selected demographic factors with rUTI | 12 months | 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) |
| Number free from recurrent UTIs | 12 months | 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 |
| Number free from any UTI | 12 months | Number of patients free from any UTI at one year, as defined above |
| Crossover from observation to intervention | 12 months | Patients on observation and decide to seek treatment after enrollment |
| Stone free vs not stone free correlation with rUTI | 12 months | Correlation between stone free status after intervention and recurrent UTI |
Countries
Canada, United States
Outcome results
None listed