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Completed

NCT Number: NCT04495699

Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital/University of British Columbia, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to first UTI

    Time frame: up to 12 months

    Time from first visit to first UTI, defined as above

  2. Pyelonephritis/urosepsis

    Time frame: up to 12 months

    Incidence of pyelonephritis/urosepsis

  3. Incidence of complications from intervention within 30 days

    Time frame: 30 days

    Clavien-Dindo complications, ER visits, readmissions, infections within 30 days, non-elective repeat interventions (eg for obstructing fragments)

  4. Incidence of further intervention for stones

    Time frame: 12 months

    any further stone interventions required

  5. Stone analysis correlation with rUTI

    Time frame: 12 months

    Correlation between primary outcome and stone analysis

  6. Stone free vs not stone free correlation with rUTI

    Time frame: 12 months

    Correlation between stone free status after intervention and recurrent UTI

  7. Correlation of selected demographic factors with rUTI

    Time frame: 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)

  8. Number free from recurrent UTIs

    Time frame: 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

  9. Number free from any UTI

    Time frame: 12 months

    Number of patients free from any UTI at one year, as defined above

  10. Crossover from observation to intervention

    Time frame: 12 months

    Patients on observation and decide to seek treatment after enrollment

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Columbia University
  • Massachusetts General Hospital
  • Mayo Clinic
  • University of British Columbia
  • University of California, San Diego

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2020
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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