Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495699
• Other study ID #: 0000000
• Status: Recruiting
• Start date: September 9, 2020
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: Ryan Hsi, MD
• Phone: 6153432036
• Email: ryan.hsi[@]vumc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Calculi
• Infections
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital/University of British Columbia	Vancouver	British Columbia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University	New York	New York
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	University of California San Diego	San Diego	California

Sponsors (6)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Columbia University, Massachusetts General Hospital, Mayo Clinic, University of British Columbia, University of California, San Diego

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to first UTI	Time from first visit to first UTI, defined as above	up to 12 months
Secondary	Pyelonephritis/urosepsis	Incidence of pyelonephritis/urosepsis	up to 12 months
Secondary	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)	30 days
Secondary	Incidence of further intervention for stones	any further stone interventions required	12 months
Secondary	Stone analysis correlation with rUTI	Correlation between primary outcome and stone analysis	12 months
Secondary	Stone free vs not stone free correlation with rUTI	Correlation between stone free status after intervention and recurrent UTI	12 months
Secondary	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)	12 months
Secondary	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	12 months
Secondary	Number free from any UTI	Number of patients free from any UTI at one year, as defined above	12 months
Secondary	Crossover from observation to intervention	Patients on observation and decide to seek treatment after enrollment	12 months