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Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections

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ClinicalTrials.gov Identifier: NCT04495699
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
University of British Columbia
University of California, San Diego
Mayo Clinic
Massachusetts General Hospital
Columbia University
Information provided by (Responsible Party):
Ryan Hsi, Vanderbilt University Medical Center

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
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:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Treatment of Asymptomatic Renal Calculi in Recurrent UTIs: a Prospective Observational Cohort Study
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with recurrent UTIs and asymptomatic renal calculi.
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495699


Contacts
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Contact: Ryan Hsi, MD 6153432036 ryan.hsi@vumc.org

Locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Karen Stern, MD         
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Roger Sur         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Brian Eisner         
United States, New York
Columbia University Not yet recruiting
New York, New York, United States, 10027
Contact: Kelly Healy, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Ryan Hsi         
Canada, British Columbia
Vancouver General Hospital/University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T1Z4
Contact: Ben Chew, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
University of British Columbia
University of California, San Diego
Mayo Clinic
Massachusetts General Hospital
Columbia University
Investigators
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Principal Investigator: Ryan Hsi, MD Vanderbilt University Medical Center
Publications:

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Responsible Party: Ryan Hsi, Assistant Professor, Department of Urology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04495699    
Other Study ID Numbers: 0000000
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Hsi, Vanderbilt University Medical Center:
Urinary Tract Infection
Kidney Stones
Urolithiasis
Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Kidney Calculi
Nephrolithiasis
Calculi
Urologic Diseases
Kidney Diseases
Urolithiasis
Urinary Calculi
Pathological Conditions, Anatomical