Kidney StonesNCT07193940
Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy
A study testing Flexible Ureteroscopy and extracorporeal shock wave lithotripsy (ESWL) in people with Kidney Stones, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy and safety of flexible ureterorenoscopy (fURS) versus extracorporeal shock wave lithotripsy (ESWL) in managing lower calyceal renal stones ≤15 mm and <1000 HU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Flexible Ureteroscopy and extracorporeal shock wave lithotripsy (ESWL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 y)
- Lower-calyx stone
- Less than or equal15 mm
- Mean Hounsfield (HU) <1000
Who cannot join
- Pregnancy
- Uncorrected coagulopathy
- Active UTI/obstruction
- Anatomical barriers to Flexible Ureteroscopy or extracorporeal shock wave lithotripsy coupling (e.g., prohibitive SSD/BMI).
- Cardiac devices contraindicating ESWL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine, Assiut University
Asyut
Ahmed A Ahmed Atef Mohamed Abdellatif, MD, +0201069339244, aboatef775599@gmail.com
About this study
Official title: Flexible Ureteroscopy Versus Extracorporeal Shock Wave Lithotripsy for Treatment of Lower Calyceal Renal Stones Less Than 15 mm: A Prospective Randomized Comparative Study
To compare the efficacy and safety of flexible ureterorenoscopy (fURS) versus extracorporeal shock wave lithotripsy (ESWL) in managing lower calyceal renal stones ≤15 mm and <1000 HU.
Read the detailed description
Urolithiasis is a common condition with a steadily increasing global prevalence, and lower calyceal stone treatment is particularly challenging. While stones ≤15 mm and <1000 Hounsfield Units (HU) are generally treatable, lower pole anatomy limits fragment clearance after extracorporeal shock wave lithotripsy (ESWL). Published SFR for ESWL in this location range between 60-80%, which are lower compared to other calyceal sites. Predictive factors such as stone density, size, and skin-to-stone distance are applied to optimize patients selection.
Conversely, flexible ureteroscopy (fURS) with laser lithotripsy achieves more and higher quality SFRs (80-95%) by active fragmentation and retrieval of the stones, thereby bypassing the anatomic barriers. However, It is invasive, requires anesthesia and has complications such as ureteral trauma and infection, including a small but certain risk of sepsis. EAU and AUA guidelines currently recommend either ESWL or URS for stones <20 mm, but note reduced clearance of lower-pole stones by ESWL.
This creates a therapeutic dilemma: should stones ≤15 mm and <1000 HU, theoretically ideal for ESWL, nevertheless to be managed non-invasively, or should fURS be given priority because of increased reliability? We anticipate that fURS will provide a higher 3-month stone-free rate than ESWL, though ESWL may remain a suitable first-line treatment in well-selected patients owing to lower morbidity and non-invasive nature.
- Conditions
- Kidney Stones
- Being tested
- Flexible Ureteroscopy, extracorporeal shock wave lithotripsy (ESWL)
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible UreteroscopyProcedure or surgery
Flexible Ureterorenoscopy
extracorporeal shock wave lithotripsy (ESWL)Procedure or surgery
extracorporeal shock wave lithotripsy (ESWL)
| Study group | Role | What they receive |
|---|---|---|
| Flexible Ureteroscopy | Experimental | Interventional procedure: Flexible Ureteroscopy Receives: Procedure: Flexible Ureteroscopy |
| Extracorporeal Shock Wave Lithotripsy | Experimental | Extracorporeal Shock Wave Lithotripsy (ESWL) Receives: Procedure: extracorporeal shock wave lithotripsy (ESWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atef Mohamed Abdellatif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193940
- Sponsor's protocol ID
- Ureteroscopy VS ESWL
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng CF. The effect of stone size, location, and number on the outcome of extracorporeal shock wave lithotripsy. Int Braz J Urol. 2008;34(6):759-66. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684300/
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.
PubMed 27238616Sampaio FJ, Aragao AH. Inferior pole collecting system anatomy: its probable role in extracorporeal shock wave lithotripsy. J Urol. 1992 Feb;147(2):322-4. doi: 10.1016/s0022-5347(17)37226-9.
PubMed 1732584Akman T, Binbay M, Ozgor F, Ugurlu M, Tekinarslan E, Kezer C, Aslan R, Muslumanoglu AY. Comparison of percutaneous nephrolithotomy and retrograde flexible nephrolithotripsy for the management of 2-4 cm stones: a matched-pair analysis. BJU Int. 2012 May;109(9):1384-9. doi: 10.1111/j.1464-410X.2011.10691.x. Epub 2011 Oct 28.
PubMed 22093679Somani BK, Giusti G, Sun Y, Osther PJ, Frank M, De Sio M, Turna B, de la Rosette J. Complications associated with ureterorenoscopy (URS) related to treatment of urolithiasis: the Clinical Research Office of Endourological Society URS Global study. World J Urol. 2017 Apr;35(4):675-681. doi: 10.1007/s00345-016-1909-0. Epub 2016 Aug 4.
PubMed 27492012Fankhauser CD, Weber D, Muntener M, Poyet C, Sulser T, Hermanns T. Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5-15 mm: Results of a Randomized Controlled Trial. Eur Urol Open Sci. 2021 Feb 2;25:5-10. doi: 10.1016/j.euros.2021.01.001. eCollection 2021 Mar.
PubMed 34337498