Renal CalculiNCT05240170
RIRS for Treatment of Stones in Congenital Anomalous Kidneys
A study testing RIRS and SWL in people with Renal Calculi and Renal Anomaly, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Renal Anomaly
- What is being tested?
- RIRS and SWL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 15 Jul 2024
- 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
- The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.
Who cannot join
- Pregnant women.
- Uncorrectable coagulation disorders.
- Urinary tract obstruction distal to the stone.
- Active infection.
- Stone in a calyceal diverticulum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrograde Intrarenal Surgery for Treatment of Stones in Congenital Anomalous Kidneys: Case Matched Comparative Study With Extracorporeal Shockwave Lithotripsy
The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. In this prospective study, the investigators will evaluate the outcome of retrograde intrarenal surgery (RIRS) with extracorporeal shockwave lithotripsy (SWL) for the treatment of stones in the kidneys with rotation or position anomalies.
Read the detailed description
In current stone guidelines, the recommendations for stone therapy in the kidneys with normal anatomy are clearly stated; however, there is also no clear suggestion and treatment modality in regards to the stone treatment in anomalous kidneys. Nowadays, open surgery, percutaneous nephrolithotomy (PNL), SWL, and RIRS are used for the treatment of these kidney stones. However, there is no clear consensus on which treatment modalities should be used; each modality has its unique advantages and drawbacks. in this study, the investigators will prospectively evaluate the safety and efficacy of RIRS in treatment of stones in kidneys with rotation or position anomalies. The investigators will compare the results with a matched group of patients who were treated with SWL. The results of this study may help clarify treatment options in the management of patients with stones and renal anomalies.
- Conditions
- Renal Calculi, Renal Anomaly
- Being tested
- RIRS, SWL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIRSDevice
Also called Retrograde flexible ureteroscopy
The standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure.
SWLDevice
Patients who underwent SWL at our institution in the past five years. According to (a) the type of renal anomaly (rotation, position, or rotation/position anomaly), (b) the size of the stone (±5 mm), (c) location of the stone (lower polar or non-lower polar), and (d) density of the stone (>800 HU or ≤800 HU), matched cases will be selected for comparison.
| Study group | Role | What they receive |
|---|---|---|
| RIRS group | Experimental | The standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure. Receives: Device: RIRS |
| SWL group | Experimental | The medical records of all patients who underwent SWL at our institution in the past five years will be reviewed. Patients with renal rotation or position anomalies, as defined by NCCT and/or IVU, will be included for possible study participation. Receives: Device: SWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
Stone-free status is defined as no residual fragments of ≥3 mm on abdominal NCCT and/or X-ray KUB.
Measured: 3-months after the intervention.
Secondary outcomes (3)
Complication rate
intraoperative and postoperative complications
Measured: intraoperative till 3 months postoperative complications
operative time
from starting till the end of the procedure
Measured: the procedure time
Re-treatment rate
need for reintervention
Measured: during the post-operative 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Mar 2022
- Primary completion15 Feb 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- The 1st group: RIRS The 2nd group: SWL
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, MD, Principal investigator, Al-Azhar University Hospitals, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240170
- Sponsor's protocol ID
- Uro_Azhar_1_022
- Status last verified
- Apr 2022
- First submitted
- 4 Feb 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahmed AF, ElMesery M, Algammal M, Daoud A, Solyman A, Mosaad A. Retrograde intrarenal surgery for treatment of stones in congenital anomalous kidneys: a case-matched comparative study with extracorporeal shockwave lithotripsy. Urolithiasis. 2025 Oct 6;53(1):188. doi: 10.1007/s00240-025-01860-8.
PubMed 41051538
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Intrarenal Surgery for Treatment of Stones in Congenital Anomalous Kidneys: Case Matched Comparative Study With Extracorporeal Shockwave Lithotripsy
- ClinicalTrials.gov ID
- NCT05240170
- Acronym / sponsor ID
- Uro_Azhar_1_022
- Conditions
- Renal Calculi, Renal Anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 15 Feb 2022 (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.
The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. In this prospective study, the investigators will evaluate the outcome of retrograde intrarenal surgery (RIRS) with extracorporeal shockwave lithotripsy (SWL) for the treatment of stones in the kidneys with rotation or position anomalies.
Detailed description
In current stone guidelines, the recommendations for stone therapy in the kidneys with normal anatomy are clearly stated; however, there is also no clear suggestion and treatment modality in regards to the stone treatment in anomalous kidneys. Nowadays, open surgery, percutaneous nephrolithotomy (PNL), SWL, and RIRS are used for the treatment of these kidney stones. However, there is no clear consensus on which treatment modalities should be used; each modality has its unique advantages and drawbacks. in this study, the investigators will prospectively evaluate the safety and efficacy of RIRS in treatment of stones in kidneys with rotation or position anomalies. The investigators will compare the results with a matched group of patients who were treated with SWL. The results of this study may help clarify treatment options in the management of patients with stones and renal anomalies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The 1st group: RIRS The 2nd group: SWL
| Arm | Type | Receives |
|---|---|---|
| RIRS group | Experimental | Device: RIRSThe standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure. |
| SWL group | Experimental | Device: SWLThe medical records of all patients who underwent SWL at our institution in the past five years will be reviewed. Patients with renal rotation or position anomalies, as defined by NCCT and/or IVU, will be included for possible study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.
Key exclusion criteria (5 listed)
- Pregnant women.
- Uncorrectable coagulation disorders.
- Urinary tract obstruction distal to the stone.
- Active infection.
- Stone in a calyceal diverticulum
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 |
|---|---|---|
| RIRSAlso: Retrograde flexible ureteroscopyThe standard RIRS will be performed using a disposable flexible ureteroscope. Holmium: YAG laser will be used for stone dusting and fragmentation. If indicated, JJ ureteral stent will be placed at the end of the procedure. | Device | RIRS group |
| SWLPatients who underwent SWL at our institution in the past five years. According to (a) the type of renal anomaly (rotation, position, or rotation/position anomaly), (b) the size of the stone (±5 mm), (c) location of the stone (lower polar or non-lower polar), and (d) density of the stone (>800 HU or ≤800 HU), matched cases will be selected for comparison. | Device | SWL group |
Primary outcome
Stone-free rate
Time frame: 3-months after the intervention.
Stone-free status is defined as no residual fragments of ≥3 mm on abdominal NCCT and/or X-ray KUB.
3 secondary outcomes
Complication rate
Time frame: intraoperative till 3 months postoperative complications
operative time
Time frame: the procedure time
Re-treatment rate
Time frame: during the post-operative 3 months
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 12 Aug 2026.
- Derived from this study: PubMed 41051538Ahmed AF, ElMesery M, Algammal M, Daoud A, Solyman A, Mosaad A. Retrograde intrarenal surgery for treatment of stones in congenital anomalous kidneys: a case-matched comparative study with extracorporeal shockwave lithotripsy. Urolithiasis. 2025 Oct 6;53(1):188. doi: 10.1007/s00240-025-01860-8.
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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.
Abul-fotouh Ahmed, MD principal investigator
Al-Azhar University Hospitals, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIRS and SWL in people with Renal Calculi and Renal Anomaly, run by Al-Azhar 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 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: finished, as of the sponsor's last update on 12 Aug 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-months 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 NCT05240170, which also lists 1 linked publication.
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 12 Aug 2026.