Upper Ureteric Stonesmm millimeterNCT07362784
Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 10 mm In Maximum Dimension. A Randomized Comparative Study
A study testing antegrade flexible ureteroscopy for group A and retrograde flexible ureteroscopy For group B in people with Upper Ureteric Stones, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the efficacy and safety of antegrade flexible ureteroscopic lithotripsy in treating upper ureteric stones >10 mm in maximum dimension and impacted upper ureteric stones irrespective of size in comparison to retrograde ureteroscopic lithotripsy and evaluate feasibility, adverse events… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Ureteric Stones
- What is being tested?
- antegrade flexible ureteroscopy for group A and retrograde flexible ureteroscopy For group B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 14 Sep 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years
Who cannot join
- unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups < 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the efficacy and safety of antegrade flexible ureteroscopic lithotripsy in treating upper ureteric stones >10 mm in maximum dimension and impacted upper ureteric stones irrespective of size in comparison to retrograde ureteroscopic lithotripsy and evaluate feasibility, adverse events, hospital stay and cost benefit of both techniques
Read the detailed description
Study included 100 patients meeting the inclusion criteria for having an upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years. Stones were deemed impacted in case of lack of movement for 1 month on 2 computed tomography scans of urinary tract (CTUT) or non passage of guide wire and / or dye intraoperatively. Exclusion criteria were unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups < 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors. All patients signed an informed consent and were randomized by closed envelop method into 2 groups: group A included 50 patients treated by antegrade flexible URSL and group B included 50 patients treated by retrograde flexible URSL.
Preoperatively, all patients underwent evaluation by medical history, physical examination, laboratory work up including complete blood count (CBC), kidney functions test, liver functions test, hepatitis markers, coagulation profile, completer urine analysis and urine culture with sensitivity. All patients were subjected to imaging studies including pelvi-abdominal ultrasound, plain X-ray of urinary tract and CTUT. Postoperatively, all patient had CBC done a few hours after the procedure, monitored for vital signs and urine color. All patients were assessed for residual stone presence 3 weeks after procedure by CTUT. Stone free status was defined by absence of stone fragment of 4 mm or more in maximum diameter. The primary endpoint was stone free rate. Secondary endpoints were complications, operative time, fluoroscopy time, mean hemoglobin drop, hospital stay and need for auxiliary procedures.
- Conditions
- Upper Ureteric Stones
- Being tested
- antegrade flexible ureteroscopy for group A, retrograde flexible ureteroscopy For group B
- Keywords
- flexible ureteroscopy, proximal ureteric stones, laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antegrade flexible ureteroscopy for group AProcedure or surgery
The antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile
retrograde flexible ureteroscopy For group BProcedure or surgery
he antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Antegrade flexible ureteroscopy Receives: Procedure: antegrade flexible ureteroscopy for group A |
| group B | Active comparator | retrograde flexible ureteroscopy Receives: Procedure: retrograde flexible ureteroscopy For group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
stone free rate was compared between the 2 arms
Measured: 3 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Mar 2022
- Primary completion10 Aug 2025
- Study completion14 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Ureteric StonesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Saad Abdulbaki Hafez Attaby, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362784
- Sponsor's protocol ID
- FAMSU M D 23/2021
- Acronym
- mm millimeter
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Gokce MI, Akpinar C, Obaid K, Suer E, Gulpinar O, Beduk Y. Comparison of retrograde ureterorenoscopy (URS) and percutaneous anterograde ureteroscopy for removal of impacted upper ureteral stones >10mm in the elderly population. Int Braz J Urol. 2021 Jan-Feb;47(1):64-70. doi: 10.1590/S1677-5538.IBJU.2019.0638.
PubMed 32840338Elgebaly O, Abdeldayem H, Idris F, Elrifai A, Fahmy A. Antegrade mini-percutaneous flexible ureteroscopy versus retrograde ureteroscopy for treating impacted proximal ureteric stones of 1-2 cm: A prospective randomised study. Arab J Urol. 2020 Aug 23;18(3):176-180. doi: 10.1080/2090598X.2020.1769385.
PubMed 33029428Mohey A, Abdelfattah AA, Mohammed AE, Marzouk A, El-Dakhakhny AS. Comparative study between antegrade flexible ureteroscopy and reterograde intrarenal surgery in the management of impacted upper ureteric stones 1.5 cm or larger. World J Urol. 2023 Dec;41(12):3731-3736. doi: 10.1007/s00345-023-04672-w. Epub 2023 Nov 3.
PubMed 37921933Wishahi M, Attaby M, El Halaby R, Elbaz AG, Hasan M. Efficacy and safety of antegrade ureteroscopic lithotripsy versus retrograde ureteroscopic lithotripsy in the treatment of upper ureteric stones measuring > 10 mm in maximum dimension and/or impacted stones: randomized comparative study. World J Urol. 2026 May 5;44(1):340. doi: 10.1007/s00345-026-06445-7.
PubMed 42086948
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of Antegrade Uretroscopic Lithotripsy Versus Retrograde Ureteroscopic Lithotripsy In The Treatment Of Upper Ureteric Stones Measuring > 10 mm In Maximum Dimension. A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07362784
- Acronym / sponsor ID
- mm millimeter / FAMSU M D 23/2021
- Conditions
- Upper Ureteric Stones
- Keywords
- flexible ureteroscopy, proximal ureteric stones, laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 14 Sep 2025 (actual)
- First posted
- 23 Jan 2026 (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.
This study aims to assess the efficacy and safety of antegrade flexible ureteroscopic lithotripsy in treating upper ureteric stones >10 mm in maximum dimension and impacted upper ureteric stones irrespective of size in comparison to retrograde ureteroscopic lithotripsy and evaluate feasibility, adverse events, hospital stay and cost benefit of both techniques
Detailed description
Study included 100 patients meeting the inclusion criteria for having an upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years. Stones were deemed impacted in case of lack of movement for 1 month on 2 computed tomography scans of urinary tract (CTUT) or non passage of guide wire and / or dye intraoperatively. Exclusion criteria were unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups < 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors. All patients signed an informed consent and were randomized by closed envelop method into 2 groups: group A included 50 patients treated by antegrade flexible URSL and group B included 50 patients treated by retrograde flexible URSL.
Preoperatively, all patients underwent evaluation by medical history, physical examination, laboratory work up including complete blood count (CBC), kidney functions test, liver functions test, hepatitis markers, coagulation profile, completer urine analysis and urine culture with sensitivity. All patients were subjected to imaging studies including pelvi-abdominal ultrasound, plain X-ray of urinary tract and CTUT. Postoperatively, all patient had CBC done a few hours after the procedure, monitored for vital signs and urine color. All patients were assessed for residual stone presence 3 weeks after procedure by CTUT. Stone free status was defined by absence of stone fragment of 4 mm or more in maximum diameter. The primary endpoint was stone free rate. Secondary endpoints were complications, operative time, fluoroscopy time, mean hemoglobin drop, hospital stay and need for auxiliary procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: antegrade flexible ureteroscopy for group AAntegrade flexible ureteroscopy |
| group B | Active comparator | Procedure: retrograde flexible ureteroscopy For group Bretrograde flexible ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with upper urteric stone larger than 10 mm in maximum diameter from the level of pelviureteric junction to upper border of sacroiliac junction and aged ≥18 years
Key exclusion criteria (1 listed)
- unresolved urinary tract infection, uncorrected coagulopathy, pregnancy, anatomical abnormalities of the urinary system as horse shoe kidney, pelvic ectopic kidney and ureteric strictures, severe orthopedic malformation hindering prone position or antegrade ureteric access as kyphosis and scoliosis, Pediatric age groups < 18 years, ureteric Stent in place, concurrent renal stones, bladder cancer, upper urothelial tumors or renal tumors
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 |
|---|---|---|
| antegrade flexible ureteroscopy for group AThe antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile | Procedure or surgery | group A |
| retrograde flexible ureteroscopy For group Bhe antegrade approach with this stone size will further prove the superior stone free rate compared with the retrograde approach, widen the indication for the antegrade approach and prove the more favorable perioperative safety profile | Procedure or surgery | group B |
Primary outcome
stone free rate
Time frame: 3 weeks after the intervention
stone free rate was compared between the 2 arms
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 23 Jan 2026.
- Background: PubMed 32840338Gokce MI, Akpinar C, Obaid K, Suer E, Gulpinar O, Beduk Y. Comparison of retrograde ureterorenoscopy (URS) and percutaneous anterograde ureteroscopy for removal of impacted upper ureteral stones >10mm in the elderly population. Int Braz J Urol. 2021 Jan-Feb;47(1):64-70. doi: 10.1590/S1677-5538.IBJU.2019.0638.
- Background: PubMed 33029428Elgebaly O, Abdeldayem H, Idris F, Elrifai A, Fahmy A. Antegrade mini-percutaneous flexible ureteroscopy versus retrograde ureteroscopy for treating impacted proximal ureteric stones of 1-2 cm: A prospective randomised study. Arab J Urol. 2020 Aug 23;18(3):176-180. doi: 10.1080/2090598X.2020.1769385.
- Background: PubMed 37921933Mohey A, Abdelfattah AA, Mohammed AE, Marzouk A, El-Dakhakhny AS. Comparative study between antegrade flexible ureteroscopy and reterograde intrarenal surgery in the management of impacted upper ureteric stones 1.5 cm or larger. World J Urol. 2023 Dec;41(12):3731-3736. doi: 10.1007/s00345-023-04672-w. Epub 2023 Nov 3.
- Derived from this study: PubMed 42086948Wishahi M, Attaby M, El Halaby R, Elbaz AG, Hasan M. Efficacy and safety of antegrade ureteroscopic lithotripsy versus retrograde ureteroscopic lithotripsy in the treatment of upper ureteric stones measuring > 10 mm in maximum dimension and/or impacted stones: randomized comparative study. World J Urol. 2026 May 5;44(1):340. doi: 10.1007/s00345-026-06445-7.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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?
A study testing antegrade flexible ureteroscopy for group A and retrograde flexible ureteroscopy For group B in people with Upper Ureteric Stones, run by Ain Shams 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 1 inclusion and 1 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 23 Jan 2026. 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?
stone free rate (time frame: 3 weeks after the intervention). 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 NCT07362784, which also lists 4 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 23 Jan 2026.