Urinary Tract InfectionsNCT04495699
Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
An observational study of Urinary Tract Infections and Kidney Stone, run by Vanderbilt University Medical Center at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Kidney Stone
- What is being tested?
- None - observational
- How many people
- 94 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 9 Sep 2020to 1 Sep 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent UTIs and asymptomatic renal calculi.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University
New York, New York, 10027
Mayo Clinic Arizona
Phoenix, Arizona, 85054
University of California San Diego
San Diego, California, 92093
Canada1 site
Vancouver General Hospital/University of British Columbia
Vancouver, British Columbia, V6T1Z4
About this study
Official title: Treatment of Asymptomatic Renal Calculi in Recurrent UTIs: a Prospective Observational Cohort Study
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.
Read the 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.
- Conditions
- Urinary Tract Infections, Kidney Stone
- Being tested
- None - observational
- Keywords
- Urinary Tract Infection, Kidney Stones, Urolithiasis
- Medical subject headings
- Urinary Tract Infections, Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observationalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None - observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
Time to first UTI
Time from first visit to first UTI, defined as above
Measured: up to 12 months
Pyelonephritis/urosepsis
Incidence of pyelonephritis/urosepsis
Measured: 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)
Measured: 30 days
Incidence of further intervention for stones
any further stone interventions required
Measured: 12 months
Stone analysis correlation with rUTI
Correlation between primary outcome and stone analysis
Measured: 12 months
Stone free vs not stone free correlation with rUTI
Correlation between stone free status after intervention and recurrent UTI
Measured: 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)
Measured: 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
Measured: 12 months
Number free from any UTI
Number of patients free from any UTI at one year, as defined above
Measured: 12 months
Crossover from observation to intervention
Patients on observation and decide to seek treatment after enrollment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start9 Sep 2020
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, University of California, San Diego, Mayo Clinic, Massachusetts General Hospital, Columbia University
- Responsible party
- Principal investigator, Ryan Hsi, Vanderbilt University Medical Center
- Investigators
- Ryan Hsi, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495699
- Sponsor's protocol ID
- 0000000
- Status last verified
- Oct 2025
- First submitted
- 28 Jul 2020
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.
PubMed 31042112Agarwal DK, Krambeck AE, Sharma V, Maldonado FJ, Westerman ME, Knoedler JJ, Rivera ME. Treatment of non-obstructive, non-struvite urolithiasis is effective in treatment of recurrent urinary tract infections. World J Urol. 2020 Aug;38(8):2029-2033. doi: 10.1007/s00345-019-02977-3. Epub 2019 Oct 23.
PubMed 31646382Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
PubMed 27238616Barr-Beare E, Saxena V, Hilt EE, Thomas-White K, Schober M, Li B, Becknell B, Hains DS, Wolfe AJ, Schwaderer AL. The Interaction between Enterobacteriaceae and Calcium Oxalate Deposits. PLoS One. 2015 Oct 8;10(10):e0139575. doi: 10.1371/journal.pone.0139575. eCollection 2015.
PubMed 26448465Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.
PubMed 22677710Flannigan RK, Battison A, De S, Humphreys MR, Bader M, Lellig E, Monga M, Chew BH, Lange D. Evaluating factors that dictate struvite stone composition: A multi-institutional clinical experience from the EDGE Research Consortium. Can Urol Assoc J. 2018 Apr;12(4):131-136. doi: 10.5489/cuaj.4804. Epub 2017 Dec 22.
PubMed 29319486Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Dis Mon. 2003 Feb;49(2):53-70. doi: 10.1067/mda.2003.7.
PubMed 12601337Geerlings SE. Clinical Presentations and Epidemiology of Urinary Tract Infections. Microbiol Spectr. 2016 Oct;4(5). doi: 10.1128/microbiolspec.UTI-0002-2012.
PubMed 27780014Griebling TL. Urologic diseases in america project: trends in resource use for urinary tract infections in men. J Urol. 2005 Apr;173(4):1288-94. doi: 10.1097/01.ju.0000155595.98120.8e.
PubMed 15758784Omar M, Abdulwahab-Ahmed A, Chaparala H, Monga M. Does Stone Removal Help Patients with Recurrent Urinary Tract Infections? J Urol. 2015 Oct;194(4):997-1001. doi: 10.1016/j.juro.2015.04.096. Epub 2015 Apr 30.
PubMed 25936865
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Asymptomatic Renal Calculi in Recurrent UTIs: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04495699
- Acronym / sponsor ID
- 0000000
- Conditions
- Urinary Tract Infections, Kidney Stone
- Keywords
- Urinary Tract Infection, Kidney Stones, Urolithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of British Columbia, University of California, San Diego, Mayo Clinic, Massachusetts General Hospital, Columbia University
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: None - observationalPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent UTIs and asymptomatic renal calculi.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - observationalIf 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. | Other | Stone treated |
Primary outcome
Recurrent urinary tract infections
Time frame: 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
10 secondary outcomes
Time to first UTI
Time frame: up to 12 months
Pyelonephritis/urosepsis
Time frame: up to 12 months
Incidence of complications from intervention within 30 days
Time frame: 30 days
Incidence of further intervention for stones
Time frame: 12 months
Stone analysis correlation with rUTI
Time frame: 12 months
Stone free vs not stone free correlation with rUTI
Time frame: 12 months
Correlation of selected demographic factors with rUTI
Time frame: 12 months
Number free from recurrent UTIs
Time frame: 12 months
Number free from any UTI
Time frame: 12 months
Crossover from observation to intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Background: PubMed 31042112Anger J, Lee U, Ackerman AL, Chou R, Chughtai B, Clemens JQ, Hickling D, Kapoor A, Kenton KS, Kaufman MR, Rondanina MA, Stapleton A, Stothers L, Chai TC. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. 2019 Aug;202(2):282-289. doi: 10.1097/JU.0000000000000296. Epub 2019 Jul 8.
- Background: PubMed 31646382Agarwal DK, Krambeck AE, Sharma V, Maldonado FJ, Westerman ME, Knoedler JJ, Rivera ME. Treatment of non-obstructive, non-struvite urolithiasis is effective in treatment of recurrent urinary tract infections. World J Urol. 2020 Aug;38(8):2029-2033. doi: 10.1007/s00345-019-02977-3. Epub 2019 Oct 23.
- Background: PubMed 27238616Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
- Background: PubMed 26448465Barr-Beare E, Saxena V, Hilt EE, Thomas-White K, Schober M, Li B, Becknell B, Hains DS, Wolfe AJ, Schwaderer AL. The Interaction between Enterobacteriaceae and Calcium Oxalate Deposits. PLoS One. 2015 Oct 8;10(10):e0139575. doi: 10.1371/journal.pone.0139575. eCollection 2015.
- Background: PubMed 22677710Cai T, Mazzoli S, Mondaini N, Meacci F, Nesi G, D'Elia C, Malossini G, Boddi V, Bartoletti R. The role of asymptomatic bacteriuria in young women with recurrent urinary tract infections: to treat or not to treat? Clin Infect Dis. 2012 Sep;55(6):771-7. doi: 10.1093/cid/cis534. Epub 2012 Jun 7.
- Background: PubMed 29319486Flannigan RK, Battison A, De S, Humphreys MR, Bader M, Lellig E, Monga M, Chew BH, Lange D. Evaluating factors that dictate struvite stone composition: A multi-institutional clinical experience from the EDGE Research Consortium. Can Urol Assoc J. 2018 Apr;12(4):131-136. doi: 10.5489/cuaj.4804. Epub 2017 Dec 22.
- Background: PubMed 12601337Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Dis Mon. 2003 Feb;49(2):53-70. doi: 10.1067/mda.2003.7.
- Background: PubMed 27780014Geerlings SE. Clinical Presentations and Epidemiology of Urinary Tract Infections. Microbiol Spectr. 2016 Oct;4(5). doi: 10.1128/microbiolspec.UTI-0002-2012.
- Background: PubMed 15758784Griebling TL. Urologic diseases in america project: trends in resource use for urinary tract infections in men. J Urol. 2005 Apr;173(4):1288-94. doi: 10.1097/01.ju.0000155595.98120.8e.
- Background: PubMed 25936865Omar M, Abdulwahab-Ahmed A, Chaparala H, Monga M. Does Stone Removal Help Patients with Recurrent Urinary Tract Infections? J Urol. 2015 Oct;194(4):997-1001. doi: 10.1016/j.juro.2015.04.096. Epub 2015 Apr 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Hsi, MD principal investigator
Vanderbilt University Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections and Kidney Stone, run by Vanderbilt University Medical Center at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent urinary tract infections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04495699, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.