Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
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| ClinicalTrials.gov Identifier: NCT04495699 |
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Recruitment Status :
Recruiting
First Posted : August 3, 2020
Last Update Posted : July 11, 2022
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| Condition or disease | Intervention/treatment |
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| Urinary Tract Infections Kidney Stone | Other: None - observational |
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.
| 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 2023 |
| Estimated Study Completion Date : | June 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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.
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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. |
- 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
- Time to first UTI [ Time Frame: up to 12 months ]Time from first visit to first UTI, defined as above
- Pyelonephritis/urosepsis [ Time Frame: up to 12 months ]Incidence of pyelonephritis/urosepsis
- 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)
- Incidence of further intervention for stones [ Time Frame: 12 months ]any further stone interventions required
- Stone analysis correlation with rUTI [ Time Frame: 12 months ]Correlation between primary outcome and stone analysis
- Stone free vs not stone free correlation with rUTI [ Time Frame: 12 months ]Correlation between stone free status after intervention and recurrent UTI
- 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)
- 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
- Number free from any UTI [ Time Frame: 12 months ]Number of patients free from any UTI at one year, as defined above
- Crossover from observation to intervention [ Time Frame: 12 months ]Patients on observation and decide to seek treatment after enrollment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.)
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
| Contact: Ryan Hsi, MD | 6153432036 | ryan.hsi@vumc.org |
| 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 | |
| Principal Investigator: | Ryan Hsi, MD | Vanderbilt University Medical Center |
| Responsible Party: | Ryan Hsi, Associate 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: | July 11, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Urinary Tract Infection Kidney Stones Urolithiasis |
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Infections Urinary Tract Infections Kidney Calculi Nephrolithiasis Calculi |
Urologic Diseases Kidney Diseases Urolithiasis Urinary Calculi Pathological Conditions, Anatomical |