Renal StonesNCT07730892
PCNL Versus RIRS for Management of Stones in Solitary Kidney
A study testing retrograde intra renal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) in people with Renal Stones, run by Mansoura University at 1 site in Egypt.
Trial summary
Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- retrograde intra renal surgery (RIRS) and percutaneous nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Nov 2024to 1 Oct 2026
- 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
- Patients with anatomical or functional solitary kidney.
- Renal stones ≤ 3 cm in largest diameter- as measured by non-contrast spiral CT
- Age ≥ 18 years.
Who cannot join
- Patients who did not meet the above criteria.
- bleeding diathesis or those on anticoagulant therapy.
- concomitant pathology as ureteric stricture or renal congenital anomalies .
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology center , Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for Management of Stones in Solitary Kidney: Assessment of Outcomes and Complications Through a Prospective Non Randomized Trial
Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. The study aims to compare the safety and efficacy of the use of percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy in the treatment of renal stones _ ≤ 3 cm in largest diameter through a prospective non randomized study in the period between August 2024 and August 2026. Stone-free rate will be assessed by NCCT done at 1st day postoperative and after 3 months. For Evaluation of kidney function postoperatively, creatinine clearance will be done after 1month and renal isotope scan will be done after 3 months. In addition, the results will be compared to the data of the patients with solitary kidney and renal stones who were retrospectively treated by PCNL or RIRS in the period between 2002 and 2024. The cases should fulfil the same inclusion criteria of the prospective study.
- Conditions
- Renal Stones
- Being tested
- retrograde intra renal surgery (RIRS), percutaneous nephrolithotomy (PCNL)
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde intra renal surgery (RIRS)Procedure or surgery
standard retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney
percutaneous nephrolithotomy (PCNL)Procedure or surgery
standard percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney
| Study group | Role | What they receive |
|---|---|---|
| RIRS | Experimental | patients undergo retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney Receives: Procedure: retrograde intra renal surgery (RIRS) |
| PCNL | Experimental | patients undergo percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney Receives: Procedure: percutaneous nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate
Stone-free status: it will be assessed by NCCT (defined as the absence of any stones or presence of only clinically insignificant residual stones < 4 mm as measured by NCCT). Sub classified to
- Initial stone free rate (1st day postoperative)
- Final stone free rate (after 3 months)
Measured: within 3 months after surgery
Secondary outcomes (7)
complication rate
intra-operative and post operative complications according to clavien- dindo classification
Measured: within 30 days after surgery
number of sessions
number of sessions needed to achieve complete stone clearance
Measured: 3 months after surgery
renal function evaluation
renal function assessed by eGFR
Measured: within 3 months after surgery
auxiliary procedures
need for auxiliary procedures after primary intervention
Measured: within 3 months after surgery
hospital stay
duration of postoperative hospital stay
Measured: from date of surgery until hospital discharge ( up to 30 days )
renal function evaluation
assessment of renal function by serum creatinine
Measured: within 1 month after surgery
renal function evaluation
assessment of renal function by DTPA renography
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start23 Nov 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M. Shoma, Professor of urology, Principal investigator, Urology and Nephrology Center , Mansoura university , Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730892
- Sponsor's protocol ID
- MD.24.09.899
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 28 Jul 2026
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery for Management of Stones in Solitary Kidney: Assessment of Outcomes and Complications Through a Prospective Non Randomized Trial
- ClinicalTrials.gov ID
- NCT07730892
- Acronym / sponsor ID
- MD.24.09.899
- Conditions
- Renal Stones
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Nov 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 Jul 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.
Few studies compared PCNL and RIRS for stones in solitary kidney. Current guidelines do not provide clear recommendations concerning the management of renal stones in patients with solitary kidney. The study aims to compare the safety and efficacy of the use of percutaneous nephrolithotomy (PCNL) and flexible ureteroscopy in the treatment of renal stones _ ≤ 3 cm in largest diameter through a prospective non randomized study in the period between August 2024 and August 2026. Stone-free rate will be assessed by NCCT done at 1st day postoperative and after 3 months. For Evaluation of kidney function postoperatively, creatinine clearance will be done after 1month and renal isotope scan will be done after 3 months. In addition, the results will be compared to the data of the patients with solitary kidney and renal stones who were retrospectively treated by PCNL or RIRS in the period between 2002 and 2024. The cases should fulfil the same inclusion criteria of the prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIRS | Experimental | Procedure: retrograde intra renal surgery (RIRS)patients undergo retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney |
| PCNL | Experimental | Procedure: percutaneous nephrolithotomy (PCNL)patients undergo percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with anatomical or functional solitary kidney.
- Renal stones ≤ 3 cm in largest diameter- as measured by non-contrast spiral CT
- Age ≥ 18 years.
Key exclusion criteria (3 listed)
- Patients who did not meet the above criteria.
- bleeding diathesis or those on anticoagulant therapy.
- concomitant pathology as ureteric stricture or renal congenital anomalies .
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 |
|---|---|---|
| retrograde intra renal surgery (RIRS)standard retrograde intrarenal surgery (RIRS) for management of stones in solitary kidney | Procedure or surgery | RIRS |
| percutaneous nephrolithotomy (PCNL)standard percutaneous nephrolithotomy (PCNL) for management of stones in solitary kidney | Procedure or surgery | PCNL |
Primary outcome
stone free rate
Time frame: within 3 months after surgery
Stone-free status: it will be assessed by NCCT (defined as the absence of any stones or presence of only clinically insignificant residual stones < 4 mm as measured by NCCT). Sub classified to * Initial stone free rate (1st day postoperative) * Final stone free rate (after 3 months)
7 secondary outcomes
complication rate
Time frame: within 30 days after surgery
number of sessions
Time frame: 3 months after surgery
renal function evaluation
Time frame: within 3 months after surgery
auxiliary procedures
Time frame: within 3 months after surgery
hospital stay
Time frame: from date of surgery until hospital discharge ( up to 30 days )
renal function evaluation
Time frame: within 1 month after surgery
renal function evaluation
Time frame: within 3 months after surgery
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 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Renal Stones
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
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.
Ahmed M. Shoma, Professor of urology principal investigator
Urology and Nephrology Center , Mansoura university , 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 retrograde intra renal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) in people with Renal Stones, run by Mansoura 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 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?
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?
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: within 3 months after surgery). 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 28 Jul 2026.