Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections

NCT04495699 | Completed

• 1 other identifier: 0000000
• Study Type: observational
• Target: 94
• Locations: 2 countries
• Sites: 6

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.

Conditions

Urinary Tract Infections; Kidney Stone

Keywords

Urinary Tract Infection; Kidney Stones; Urolithiasis

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (10)

• Time to first UTI

  up to 12 months

• Pyelonephritis/urosepsis

  up to 12 months

• Incidence of complications from intervention within 30 days

  30 days

• Incidence of further intervention for stones

  12 months

• Stone analysis correlation with rUTI

  12 months

Study Arms (2)

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

Interventions

None - observational OTHER

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.

Stone treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with recurrent UTIs and asymptomatic renal calculi.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of British Columbia: collaborator
• University of California, San Diego: collaborator
• Mayo Clinic: collaborator
• Massachusetts General Hospital: collaborator
• Columbia University: collaborator

Study Sites (6)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Vancouver General Hospital/University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

Location

Related Publications (10)

• 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.

  PMID: 31042112 BACKGROUND

• Agarwal 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.

  PMID: 31646382 BACKGROUND

• Assimos 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.

  PMID: 27238616 BACKGROUND

• Barr-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.

  PMID: 26448465 BACKGROUND

• Cai 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.

  PMID: 22677710 BACKGROUND

• Flannigan 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.

  PMID: 29319486 BACKGROUND

• Foxman 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.

  PMID: 12601337 BACKGROUND

• Geerlings SE. Clinical Presentations and Epidemiology of Urinary Tract Infections. Microbiol Spectr. 2016 Oct;4(5). doi: 10.1128/microbiolspec.UTI-0002-2012.

  PMID: 27780014 BACKGROUND

• Griebling 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.

  PMID: 15758784 BACKGROUND

• Omar 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.

  PMID: 25936865 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Kidney Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrolithiasis; Kidney Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Hsi, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Urology

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 3, 2020
• Study Start: September 9, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (5)