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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07193940
- Acronym / sponsor ID
- Ureteroscopy VS ESWL
- Conditions
- Kidney Stones
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Ureteroscopy | Experimental | Procedure: Flexible UreteroscopyInterventional procedure: Flexible Ureteroscopy |
| Extracorporeal Shock Wave Lithotripsy | Experimental | Procedure: extracorporeal shock wave lithotripsy (ESWL)Extracorporeal Shock Wave Lithotripsy (ESWL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 y)
- Lower-calyx stone
- Less than or equal15 mm
- Mean Hounsfield (HU) <1000
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible UreteroscopyFlexible Ureterorenoscopy | Procedure or surgery | Flexible Ureteroscopy |
| extracorporeal shock wave lithotripsy (ESWL)extracorporeal shock wave lithotripsy (ESWL) | Procedure or surgery | Extracorporeal Shock Wave Lithotripsy |
Primary outcome
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)
Time frame: baseline
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Results publicationNg 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/
- Results publication: PubMed 27238616Assimos 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.
- Results publication: PubMed 1732584Sampaio 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.
- Results publication: PubMed 22093679Akman 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.
- Results publication: PubMed 27492012Somani 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.
- Results publication: PubMed 34337498Fankhauser 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Ahmed Atef Mohamed Abdellatif, MD (+0201069339244, aboatef775599@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate at 1 months on low-dose NCCT (no fragment >2 mm; report CIRF separately) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07193940, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.