Stone;RenalNCT03932370
Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones
An observational study of Stone;Renal, run by Assiut University at 1 site in Egypt.
Trial summary
Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL). Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stone;Renal
- What is being tested?
- Flexible ureteroscopy and mini-Percutaneus nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 118 participants
- Where
- 1 siteEgypt
- Study dates
- 27 May 2019to 27 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: no specific criteria
Who may be able to join
- Age above than 15 years
- Renal stone(s) with total burden of 2 cm or less
- Signature on written, informed consents with the details of this study requirements.
- Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)
Who cannot join
- Uncorrectable bleeding diathesis
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut Urology and Nephrology Hospital
Asyut, Asyut Governorate, 71515
About this study
Official title: Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.
Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).
Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (>2cm); stones with high densities (>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.
Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.
- Conditions
- Stone;Renal
- Being tested
- Flexible ureteroscopy, mini-Percutaneus nephrolithotomy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible ureteroscopyProcedure or surgery
Also called RIRS, f.URS, Retrograde Intrarenal Surgery
The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water.
mini-Percutaneus nephrolithotomyProcedure or surgery
Also called Mini-perc, Mini-PCNL, m.PCNL
The procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope
| Study group | Role | What they receive |
|---|---|---|
| f-URS | Not described Receives: Procedure: Flexible ureteroscopy | |
| mini-PCNL | Not described Receives: Procedure: mini-Percutaneus nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
initial stone clearance
Number of participants who has been totally cleared of stones as measured by KUB and ultrasound
Measured: 24 hours after the operation
final stone clearance
Number of participants who has been totally cleared of stones as measured by non-contrast CT
Measured: 90 days after the operation
Secondary outcomes (3)
Operative time
time passed during the operation
Measured: Within 24 hours
Hospital stay
Number of days the patient has been hospitalised
Measured: Within a week from the operation
Haemoglobin drop
The percentage of haemoglobin drop before and after the operation
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start27 May 2019
- Primary completion30 Jul 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone;RenalStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Esam Saad Mohamed Darwish, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932370
- Sponsor's protocol ID
- NCT03932370
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.
- ClinicalTrials.gov ID
- NCT03932370
- Acronym / sponsor ID
- NCT03932370
- Conditions
- Stone;Renal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 May 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 30 Apr 2019 (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.
Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).
Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (>2cm); stones with high densities (>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.
Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| f-URS | – | Procedure: Flexible ureteroscopy |
| mini-PCNL | – | Procedure: mini-Percutaneus nephrolithotomy |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- no specific criteria
Key inclusion criteria (4 listed)
- Age above than 15 years
- Renal stone(s) with total burden of 2 cm or less
- Signature on written, informed consents with the details of this study requirements.
- Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)
Key exclusion criteria (2 listed)
- Uncorrectable bleeding diathesis
- Current pregnancy
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 ureteroscopyAlso: RIRS, f.URS, Retrograde Intrarenal SurgeryThe procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water. | Procedure or surgery | f-URS |
| mini-Percutaneus nephrolithotomyAlso: Mini-perc, Mini-PCNL, m.PCNLThe procedure is done in the prone position under fluoroscopy guidance with a semi-rigid 12Fr. Nephroscope | Procedure or surgery | mini-PCNL |
Primary outcome
initial stone clearance
Time frame: 24 hours after the operation
Number of participants who has been totally cleared of stones as measured by KUB and ultrasound
final stone clearance
Time frame: 90 days after the operation
Number of participants who has been totally cleared of stones as measured by non-contrast CT
3 secondary outcomes
Operative time
Time frame: Within 24 hours
Hospital stay
Time frame: Within a week from the operation
Haemoglobin drop
Time frame: within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stone;Renal, 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 2 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
initial stone clearance (time frame: 24 hours after the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.