Renal StonesNCT02645058
RIRS Versus ESWL for the Treatment of Renal Stones
A study testing RIRS, ESWL and Rigid and flexible ureteroscope in people with Renal Stones, run by University of Turin, Italy at 1 site in Italy.
Trial summary
To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Stones
- What is being tested?
- RIRS, ESWL and Rigid and flexible ureteroscope
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2015to 19 Jun 2019
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- renal stone measuring 6 to 20 mm
- signing informed consent
- WHO performance status 0-2
Who cannot join
- Other stone >5 mm
- concomitant ureteral stones
- BMI > 35
- severe coagulopathy
- impossibility to sign informed consent
- pregnancy
- age < 18 years old or > 85
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study
To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.
Read the detailed description
European urological guidelines consider RIRS and ESWL the treatments of choice for renal stones < 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter. A flexible ureteroscope is used for these kind of procedure. Through this device a laser fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed with a basket. In some cases, according to intraoperative findings, a ureteral stent can be push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to treat the stones by shock waves generated by a specific machine which work in direct contact with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally reach the stones. Such energy allows to break the stones in small fragments, that wll be spontaneously passed by the patients. Specific parameters of these treatments are discussed in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS versus ESWL, but only for renal stones located in the inferior calices and smaller then 10 mm. There are not other studies comparing the two procedures and there are not proofs that RIRS ensures better outcomes for other renal stones (neither for size nor for location).
- Conditions
- Renal Stones
- Being tested
- RIRS, ESWL, Rigid and flexible ureteroscope, Lithotripter, Holmium laser
- Keywords
- Ureterorenoscopy, extracorporeal shock waves lithotripsy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIRSProcedure or surgery
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
ESWLProcedure or surgery
Treatment by extracorporeal shock waves lithotripsy
Rigid and flexible ureteroscopeDevice
LithotripterDevice
Holmium laserDevice
Basket for fragment removalDevice
General or spinal anesthesiaProcedure or surgery
Intravenous pain medicationDrug
If required by the patient
X-rayDevice
To focus the stone
UltrasoundDevice
To focus the stone
| Study group | Role | What they receive |
|---|---|---|
| RIRS (retrograde intrarenal surgery) | Experimental | In the first arm (RIRS) the patients will be treated by a standard retrograde ureterorenoscopy and Holmium laser lithotripsy. Preoperative exams will be abdomen ultrasound and Xray (CT in case of stones > 15 mm), urine analysis and culture (according to all the more recent guidelines). Surgeries will be performed under general or spinal anesthesia, according to anesthesiologist evaluation. According with standard technique, ureteroscopy will be performed using both rigid and flexible ureteroscope. Lithotripsy will be performed by Holmium laser. Major stone fragments will be removed at the end of the procedure. Finally a double J ureteral stent will be push in specific cases depending on intraoperative findings (length of the procedure, macroscopic view of the ureter, residual stones etc.). RIRS will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events. Receives: Procedure: RIRS; Device: Rigid and flexible ureteroscope; Device: Holmium laser; Device: Basket for fragment removal; Procedure: General or spinal anesthesia; Device: X-ray |
| ESWL (extracorporeal shockwaves lithotripsy) | Experimental | In the second arm (ESWL) the patients will be treated by a standard extracorporeal shock waves lithotripsy (ESWL). Preoperative exams will be the same as first arm. No general or spinal anaesthesia will be used, but just intravenous medications if required. Ultrasound and/or X-Ray will be used to locate the stone. Power and number of shock waves will consist in 20-24 KV and 3000-3500 sw respectively, according to individual tolerance. ESWL will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events. Receives: Procedure: ESWL; Device: Lithotripter; Drug: Intravenous pain medication; Device: X-ray; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients stone free SFR 4
Patients with residual fragments < 5 mm after treatment
Measured: 1 month from treatment
Secondary outcomes (7)
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Measured: 1 month from treatment
Number of patients stone free SFR 4
Patients with residual fragments < 5 mm after treatment
Measured: 6 months after the treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Measured: 6 months after the treatment
Number of patients stone free SFR 4
Patients with residual fragments < 5 mm after treatment
Measured: 1 year after the treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Measured: 1 year after the treatment
rate of complications
number of complications after treatment
Measured: within 1 month form treatment
rate of further treatment needed
number of retreatment
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start2 Mar 2015
- Primary completion30 May 2018
- Study completion19 Jun 2019
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 StonesStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore Dalmasso, University of Turin, Italy
- Investigators
- Andrea Bosio, Medicine, Principal investigator, Urology, University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645058
- Sponsor's protocol ID
- 0016589
- Status last verified
- May 2020
- First submitted
- 29 Jun 2015
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bosio A, Alessandria E, Dalmasso E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Gontero P. Flexible Ureterorenoscopy Versus Shockwave Lithotripsy for Kidney Stones </=2 cm: A Randomized Controlled Trial. Eur Urol Focus. 2022 Nov;8(6):1816-1822. doi: 10.1016/j.euf.2022.04.004. Epub 2022 Apr 22.
PubMed 35466071
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02645058
- Acronym / sponsor ID
- 0016589
- Conditions
- Renal Stones
- Keywords
- Ureterorenoscopy, extracorporeal shock waves lithotripsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 1 Jan 2016 (estimated)
- 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 evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.
Detailed description
European urological guidelines consider RIRS and ESWL the treatments of choice for renal stones < 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter. A flexible ureteroscope is used for these kind of procedure. Through this device a laser fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed with a basket. In some cases, according to intraoperative findings, a ureteral stent can be push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to treat the stones by shock waves generated by a specific machine which work in direct contact with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally reach the stones. Such energy allows to break the stones in small fragments, that wll be spontaneously passed by the patients. Specific parameters of these treatments are discussed in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS versus ESWL, but only for renal stones located in the inferior calices and smaller then 10 mm. There are not other studies comparing the two procedures and there are not proofs that RIRS ensures better outcomes for other renal stones (neither for size nor for location).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIRS (retrograde intrarenal surgery) | Experimental | Procedure: RIRS, Device: Rigid and flexible ureteroscope, Device: Holmium laser, Device: Basket for fragment removal, Procedure: General or spinal anesthesia, Device: X-rayIn the first arm (RIRS) the patients will be treated by a standard retrograde ureterorenoscopy and Holmium laser lithotripsy. Preoperative exams will be abdomen ultrasound and Xray (CT in case of stones > 15 mm), urine analysis and culture (according to all the more recent guidelines). Surgeries will be performed under general or spinal anesthesia, according to anesthesiologist evaluation. According with standard technique, ureteroscopy will be performed using both rigid and flexible ureteroscope. Lithotripsy will be performed by Holmium laser. Major stone fragments will be removed at the end of the procedure. Finally a double J ureteral stent will be push in specific cases depending on intraoperative findings (length of the procedure, macroscopic view of the ureter, residual stones etc.). RIRS will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events. |
| ESWL (extracorporeal shockwaves lithotripsy) | Experimental | Procedure: ESWL, Device: Lithotripter, Drug: Intravenous pain medication, Device: X-ray, Device: UltrasoundIn the second arm (ESWL) the patients will be treated by a standard extracorporeal shock waves lithotripsy (ESWL). Preoperative exams will be the same as first arm. No general or spinal anaesthesia will be used, but just intravenous medications if required. Ultrasound and/or X-Ray will be used to locate the stone. Power and number of shock waves will consist in 20-24 KV and 3000-3500 sw respectively, according to individual tolerance. ESWL will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- renal stone measuring 6 to 20 mm
- signing informed consent
- WHO performance status 0-2
Key exclusion criteria (7 listed)
- Other stone >5 mm
- concomitant ureteral stones
- BMI > 35
- severe coagulopathy
- impossibility to sign informed consent
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 |
|---|---|---|
| RIRSTreatment by ureterorenoscopy (RIRS) and laser lithotripsy | Procedure or surgery | RIRS (retrograde intrarenal surgery) |
| ESWLTreatment by extracorporeal shock waves lithotripsy | Procedure or surgery | ESWL (extracorporeal shockwaves lithotripsy) |
| Rigid and flexible ureteroscope | Device | RIRS (retrograde intrarenal surgery) |
| Lithotripter | Device | ESWL (extracorporeal shockwaves lithotripsy) |
| Holmium laser | Device | RIRS (retrograde intrarenal surgery) |
| Basket for fragment removal | Device | RIRS (retrograde intrarenal surgery) |
| General or spinal anesthesia | Procedure or surgery | RIRS (retrograde intrarenal surgery) |
| Intravenous pain medicationIf required by the patient | Drug | ESWL (extracorporeal shockwaves lithotripsy) |
| X-rayTo focus the stone | Device | ESWL (extracorporeal shockwaves lithotripsy), RIRS (retrograde intrarenal surgery) |
| UltrasoundTo focus the stone | Device | ESWL (extracorporeal shockwaves lithotripsy) |
Primary outcome
Number of patients stone free SFR 4
Time frame: 1 month from treatment
Patients with residual fragments < 5 mm after treatment
7 secondary outcomes
Number of patients stone free SFR 0
Time frame: 1 month from treatment
Number of patients stone free SFR 4
Time frame: 6 months after the treatment
Number of patients stone free SFR 0
Time frame: 6 months after the treatment
Number of patients stone free SFR 4
Time frame: 1 year after the treatment
Number of patients stone free SFR 0
Time frame: 1 year after the treatment
rate of complications
Time frame: within 1 month form treatment
rate of further treatment needed
Time frame: within 1 year
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 11 May 2020.
- Derived from this study: PubMed 35466071Bosio A, Alessandria E, Dalmasso E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Gontero P. Flexible Ureterorenoscopy Versus Shockwave Lithotripsy for Kidney Stones </=2 cm: A Randomized Controlled Trial. Eur Urol Focus. 2022 Nov;8(6):1816-1822. doi: 10.1016/j.euf.2022.04.004. Epub 2022 Apr 22.
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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.
Andrea Bosio, Medicine principal investigator
Urology, University of Turin
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, ESWL and Rigid and flexible ureteroscope in people with Renal Stones, run by University of Turin, Italy at 1 site in Italy.
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 7 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 11 May 2020. 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 Italy. 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?
Number of patients stone free SFR 4 (time frame: 1 month from treatment). 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 NCT02645058, 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 11 May 2020.