The Natural History of Minimally Symptomatic Nonobstructing Calyceal Stones

NCT04071340 | Completed

• 1 other identifier: Calyceal stones
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

• The primary aim is to study the natural history of single-calyx asymptomatic nonobstructing stone disease.
• The Secondary aim is to determine the predictors of the need for intervention and of cure in such population.

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• study the natural history of single-calyx asymptomatic nonobstructing stone disease

  Time to events indicating the need for intervention or cure

  Baseline

Interventions

non-contrast MSCT DEVICE

non-contrast multi-slice computed tomography

Abdominal ultrasonography DEVICE

Abdominal ultrasonography

Urine analysis DIAGNOSTIC_TEST

Urine analysis

Urine culture DIAGNOSTIC_TEST

Urine culture

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the outpatient clinic of urolithiasis in Assiut Urology and Nephrology Hospital.

You may qualify if:

• Cases older than 18 years with renal stone disease affecting no more than one major calyx and causing neither obstruction nor bothersome pain.
• We define calyceal obstruction as calyceal dilatation with stone impaction at the calyceal neck.
• If the stones are not impacted or are casting the calyx, they are not considered obstructing.

You may not qualify if:

• Gross or microscopic hematuria.
• Patients who have difficulty to reach our tertiary center for follow-up.
• Other pathology in the target uretero-renal unit that requires intervention, e.g., ureteropelvic junction obstruction, malignancies, ureteric stones, …etc.
• History of recurrent urinary tract infection.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (11)

• Shoag J, Tasian GE, Goldfarb DS, Eisner BH. The new epidemiology of nephrolithiasis. Adv Chronic Kidney Dis. 2015 Jul;22(4):273-8. doi: 10.1053/j.ackd.2015.04.004.

  PMID: 26088071 BACKGROUND

• Lechevallier E, Traxer O, Saussine C. [Open surgery for upper urinary tract stones]. Prog Urol. 2008 Dec;18(12):952-4. doi: 10.1016/j.purol.2008.09.013. Epub 2008 Oct 16. French.

  PMID: 19033059 BACKGROUND

• Lopez M, Hoppe B. History, epidemiology and regional diversities of urolithiasis. Pediatr Nephrol. 2010 Jan;25(1):49-59. doi: 10.1007/s00467-008-0960-5.

  PMID: 21476230 BACKGROUND

• Matlaga BR, Assimos DG. Changing indications of open stone surgery. Urology. 2002 Apr;59(4):490-3; discussion 493-4. doi: 10.1016/s0090-4295(01)01670-3.

  PMID: 11927296 BACKGROUND

• Alivizatos G, Skolarikos A. Is there still a role for open surgery in the management of renal stones? Curr Opin Urol. 2006 Mar;16(2):106-11. doi: 10.1097/01.mou.0000193379.08857.e7.

  PMID: 16479213 BACKGROUND

• Desai M, Sun Y, Buchholz N, Fuller A, Matsuda T, Matlaga B, Miller N, Bolton D, Alomar M, Ganpule A. Treatment selection for urolithiasis: percutaneous nephrolithomy, ureteroscopy, shock wave lithotripsy, and active monitoring. World J Urol. 2017 Sep;35(9):1395-1399. doi: 10.1007/s00345-017-2030-8. Epub 2017 Mar 16.

  PMID: 28303335 BACKGROUND

• Gross AJ, Knipper S, Netsch C. Managing caliceal stones. Indian J Urol. 2014 Jan;30(1):92-8. doi: 10.4103/0970-1591.124214.

  PMID: 24497690 BACKGROUND

• Lai D, Chen M, He Y, Li X. Simultaneous retrograde intrarenal surgery for ipsilateral asymptomatic renal stones in patients with ureteroscopic symptomatic ureteral stone removal. BMC Urol. 2015 Mar 19;15:22. doi: 10.1186/s12894-015-0016-7.

  PMID: 25888137 BACKGROUND

• Netsch C, Gross AJ. [Calyceal stones]. Urologe A. 2013 Aug;52(8):1135-45; quiz 1146-8. doi: 10.1007/s00120-013-3239-9. German.

  PMID: 23860670 BACKGROUND

• Porfyris O, Delakas D. Post-extracorporeal shockwave lithotripsy residual stone fragments: clinical significance and management. Scand J Urol Nephrol. 2012 Jun;46(3):188-95. doi: 10.3109/00365599.2011.644861. Epub 2012 Feb 9.

  PMID: 22321017 BACKGROUND

• Boyce CJ, Pickhardt PJ, Lawrence EM, Kim DH, Bruce RJ. Prevalence of urolithiasis in asymptomatic adults: objective determination using low dose noncontrast computerized tomography. J Urol. 2010 Mar;183(3):1017-21. doi: 10.1016/j.juro.2009.11.047. Epub 2010 Jan 21.

  PMID: 20092842 BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Ahmed S. Elazab, Professor

  Assiut University

  STUDY CHAIR

• Mohamed E. Othman, Professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator (Specialist)

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

EG (1)