Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04495699

Collaborator

University of British Columbia (Other), University of California, San Diego (Other), Mayo Clinic (Other), Massachusetts General Hospital (Other), Columbia University (Other)

Enrollment

Locations

32.7

Anticipated Duration (Months)

13.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections Kidney Stone	Other: None - observational

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:

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Treatment of Asymptomatic Renal Calculi in Recurrent UTIs: a Prospective Observational Cohort Study

Actual Study Start Date :

Sep 9, 2020

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Observation 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.
Stone treated 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.

Arm

Intervention/Treatment

Observation

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.

Stone treated

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Time to first UTI [up to 12 months]
Time from first visit to first UTI, defined as above
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
Stone free vs not stone free correlation with rUTI [12 months]
Correlation between stone free status after intervention and recurrent UTI
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	University of California San Diego	San Diego	California	United States	92093
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	Columbia University	New York	New York	United States	10027
5	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
6	Vancouver General Hospital/University of British Columbia	Vancouver	British Columbia	Canada	V6T1Z4