UrolithiasisPhase 3NCT05270421
Effect of Furosemide on ESWL Outcomes for Renal and Ureteral Calculi
A Phase 3 study testing Furosemide 40 mg and Conventional Treatment in people with Urolithiasis and Nephrolithiasis, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Urolithiasis, Nephrolithiasis, Urinary Calculi
- What is being tested?
- Furosemide 40 mg and Conventional Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2020to 30 Jul 2022
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Patients with renal or ureteral calculi referred by attending urologists to the ESWL Clinic of Shahid Faghihi Hospital, affiliated to Shiraz University of Medical Sciences (Shiraz, Iran)
Who cannot join
- An anatomic anomaly in urinary system
- Coagulopathy
- Untreated urinary tract infection
- Prior urologic surgery
- Simultaneous unilateral renal and ureteral stones
- Kidney failure (serum creatinine > 1.8 mg/dl)
Show all 12Show fewer
- Cardiovascular disease
- Hypertension
- Morbid obesity (BMI > 40 kg/m2)
- History of allergy to furosemide, glibenclamide, hydrochlorothiazide, or acetazolamide.
- Pregnancy
- Single kidney
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Faghihi Hospital
Shiraz, Fars, 71348-14336
Seyed Hossein Hosseini, MD, +989177016614, shhosseini_6687@yahoo.com
About this study
Official title: Effect of Furosemide on Outcome of Extracorporeal Shock Wave Lithotripsy for Renal and Ureteral Calculi; a Randomized, Triple-blinded, Controlled Trial
The minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients.
The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.
Read the detailed description
The present study takes the form of a double-blind, randomized clinical trial. The study conforms to the principles stated in the Declaration of Helsinki. Written informed consent is obtained from all subjects prior to enrolment. All participants are made aware of the study protocol and can withdraw from the study at any point. Given that furosemide does not adversely affect patients who do not have cardiovascular or renal diseases, no complications are predicted. The trial is pending registration with clinicaltrials.gov. This protocol was conceived following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
By taking into account an alpha error of 0.05 and a test power of 80%, the number of subjects in each group was calculated at 232. Considering a dropout rate of 10%, 250 subjects are to be included in each group.
Using block randomization, the patients are randomly assigned to one of two groups by a statistician outside of the research group. The codes for each group remain unknown to the researchers until after statistical analysis, with only the nurse and physician in charge of delivering the therapy and monitoring the patients being made aware.
All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL, which is to be performed in the standard manner. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Given that furosemide may theoretically cause pain secondary to hydronephrosis, pain will be checked for all participants via a telephone interview 24 hours later using a visual analog scale (VAS) of 0 to 10.
The outcomes and possible side effects of ESWL are evaluated for all patients after two and twelve weeks. A KUB X-ray is used for follow-up in patients with radiopaque stones, while a KUB CT scan is used otherwise. The primary outcome measure is the stone-free rate after two and twelve weeks, considered as the absence of a stone ≥ 4 mm. Secondary outcome measures include pain after 24 hours, need for re-ESWL, and need for surgery.
Before statistical analysis, adjudication of all measurements will be done by an experienced statistician outside of the research group. The adjudicator will assess the quality of each measurement and will exclude those with inadequate quality from the analysis, where they will be regarded as missing. Once the adjudication process is complete, the finalized database will be unblinded.
Data will be kept anonymous until analysis, which is to be performed by an independent statistician external to the research group. Data are analyzed using SPSS version 25 (IBM, Armonk, NY, USA). Quantitative variables will be compared using the independent t-test or Mann-Whitney U test as appropriate. Qualitative variables will be compared with the chi-squared test or Fisher's exact test as appropriate. Logistic regression will be used to compare the likelihood of success between the study groups after controlling for study variables. P-values below 0.05 indicate statistical significance in all cases.
The study's executive committee will report any adverse events to an independent Data and Safety and Monitoring Board (DSMB). The DSMB will halt the trial if patient safety is compromised or if the primary research objective is met. The DSMB will monitor all safety issues, and the DSMB statistician will report safety problems in each study group monthly. Any deaths will be investigated.
The Ethics Committee of Shiraz University of Medical Sciences approved the study protocol (code: IR.SUMS.MED.REC.1399.085). Informed consent will be obtained from all patients while they are clinically stable and not under the influence of sedatives. All participants are able to withdraw from the study at any point. Given that furosemide does not adversely affect patients who do not have cardiovascular or renal diseases, no complications were predicted. The principles of the Declaration of Helsinki will be upheld throughout this study.
- Conditions
- Urolithiasis, Nephrolithiasis, Urinary Calculi, Ureterolithiasis
- Being tested
- Furosemide 40 mg, Conventional Treatment
- Keywords
- Urolithiasis, Nephrolithiasis, ESWL
- Medical subject headings
- Urolithiasis, Nephrolithiasis, Urinary Calculi, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide 40 mgDrug
Standard ESWL + Furosemide 40 mg
Conventional TreatmentOther
Standard ESWL
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 40 mg of furosemide IV + IV midazolam + 1000 ml of normal saline 30 minutes before ESWL
+ Standard ESWL Receives: Drug: Furosemide 40 mg; Other: Conventional Treatment |
| Control Group | Active comparator | IV midazolam + 1000 ml of normal saline 30 minutes before ESWL
+ Standard ESWL Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
The absence of a stone ≥ 4 mm
Measured: 2 weeks after intervention
Stone-free rate
The absence of a stone ≥ 4 mm
Measured: 3 months after intervention
Secondary outcomes (3)
Renal colic on VAS of 0-10
Pain related to ureteral or renal calculi within 24 hours of ESWL
Measured: 24 hours after intervention
Number of participants with need for re-ESWL
The need for a repeated ESWL procedure
Measured: Within 3 months after intervention
Number of participants with need for surgery
The need for a surgery to remove the stone
Measured: Within 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Jul 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 500 patients will be randomly and equally divided into the intervention and control groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyed Hossein Hosseini, Shiraz University of Medical Sciences
- Investigators
- Dariush Irani, MD, Study director, Department of Urology, School of Medicine, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270421
- Sponsor's protocol ID
- 21179-01-01-98
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes We plan to publish the study protocol soon. The final results will be published in the form of an article after the study is completed.
Publications
Liu Y, Chen Y, Liao B, Luo D, Wang K, Li H, Zeng G. Epidemiology of urolithiasis in Asia. Asian J Urol. 2018 Oct;5(4):205-214. doi: 10.1016/j.ajur.2018.08.007. Epub 2018 Sep 6.
PubMed 30364478Safarinejad MR. Adult urolithiasis in a population-based study in Iran: prevalence, incidence, and associated risk factors. Urol Res. 2007 Apr;35(2):73-82. doi: 10.1007/s00240-007-0084-6. Epub 2007 Mar 15.
PubMed 17361397Ketabchi AA, Aziziolahi GA. Prevalence of symptomatic urinary calculi in Kerman, Iran. Urol J. 2008 Summer;5(3):156-60.
PubMed 18825621Basiri A, Shakhssalim N, Khoshdel AR, Ghahestani SM, Basiri H. The demographic profile of urolithiasis in Iran: a nationwide epidemiologic study. Int Urol Nephrol. 2010 Mar;42(1):119-26. doi: 10.1007/s11255-009-9588-z. Epub 2009 Jun 12.
PubMed 19521794Sabharwal S, Jeyaseelan L, Panda A, Gnanaraj L, Kekre NS, Devasia A. A prospective randomised double-blind placebo-controlled trial to assess the effect of diuretics on shockwave lithotripsy of calculi. Arab J Urol. 2017 Jul 8;15(4):289-293. doi: 10.1016/j.aju.2017.04.003. eCollection 2017 Dec.
PubMed 29234530Hosseini MM, Shakeri S, Manaheji F, Aminsharifi A, Ezatzadegan S, Pakfetrat M, Basiratnia M, Hosseini M. Stone composition in patients who undergo renal stone surgery: review of 423 stone analyses in southern iran. Iran J Med Sci. 2014 Jan;39(1):75-6. No abstract available.
PubMed 24453399McAdams S, Shukla AR. Pediatric extracorporeal shock wave lithotripsy: Predicting successful outcomes. Indian J Urol. 2010 Oct;26(4):544-8. doi: 10.4103/0970-1591.74457.
PubMed 21369388Azm TA, Higazy H. Effect of diuresis on extracorporeal shockwave lithotripsy treatment of ureteric calculi. Scand J Urol Nephrol. 2002;36(3):209-12. doi: 10.1080/003655902320131893.
PubMed 12201937Zomorrodi A, Golivandan J, Samady J. Effect of diuretics on ureteral stone therapy with extracorporeal shock wave lithotripsy. Saudi J Kidney Dis Transpl. 2008 May;19(3):397-400.
PubMed 18445899Sohu S, Soomro MH, Mangrio RH, Shaikh AA, Mirani A, Chand K, Jalbani MH. Efficacy of extracorporeal shockwave lithotripsy with furosemide and hydration in renal stone management: A randomised controlled trial. Arab J Urol. 2019 Jul 24;17(4):279-284. doi: 10.1080/2090598X.2019.1645262. eCollection 2019.
PubMed 31723445
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Furosemide on Outcome of Extracorporeal Shock Wave Lithotripsy for Renal and Ureteral Calculi; a Randomized, Triple-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT05270421
- Acronym / sponsor ID
- 21179-01-01-98
- Conditions
- Urolithiasis, Nephrolithiasis, Urinary Calculi, Ureterolithiasis
- Keywords
- Urolithiasis, Nephrolithiasis, ESWL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 8 Mar 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 minimally-invasive extracorporeal shockwave lithotripsy (ESWL) procedure is generally considered the best first-line treatment option for most adults and children with nephrolithiasis, especially when the calculi are smaller than 2 cm in size. Despite some promising results, few clinical trials have assessed the impact of furosemide on the outcome of ESWL. This study seeks to determine the effect of furosemide on ESWL outcomes when treating renal and ureteral calculi, hypothesizing that it will result in better outcomes for patients.
The present double-blind, randomized clinical trial includes 500 adults aged 18-60 years referring to the ESWL Clinic of Shahid Faghihi Hospital. Using block randomization, the patients are randomly assigned to one of two groups. All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Pain will be checked for all participants via a telephone interview 24 hours later. The outcomes and possible side effects of ESWL will be evaluated for all patients after two and twelve weeks.
Detailed description
The present study takes the form of a double-blind, randomized clinical trial. The study conforms to the principles stated in the Declaration of Helsinki. Written informed consent is obtained from all subjects prior to enrolment. All participants are made aware of the study protocol and can withdraw from the study at any point. Given that furosemide does not adversely affect patients who do not have cardiovascular or renal diseases, no complications are predicted. The trial is pending registration with clinicaltrials.gov. This protocol was conceived following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.
By taking into account an alpha error of 0.05 and a test power of 80%, the number of subjects in each group was calculated at 232. Considering a dropout rate of 10%, 250 subjects are to be included in each group.
Using block randomization, the patients are randomly assigned to one of two groups by a statistician outside of the research group. The codes for each group remain unknown to the researchers until after statistical analysis, with only the nurse and physician in charge of delivering the therapy and monitoring the patients being made aware.
All patients are to receive sedation with intravenous midazolam and 1000 ml of normal saline 30 minutes before ESWL, which is to be performed in the standard manner. The only difference between the groups is that in the furosemide group, 40 mg of furosemide is added to the normal saline in the drug preparation room before administration. All patients are kept under heart monitoring and pulse oximetry until recovery. Given that furosemide may theoretically cause pain secondary to hydronephrosis, pain will be checked for all participants via a telephone interview 24 hours later using a visual analog scale (VAS) of 0 to 10.
The outcomes and possible side effects of ESWL are evaluated for all patients after two and twelve weeks. A KUB X-ray is used for follow-up in patients with radiopaque stones, while a KUB CT scan is used otherwise. The primary outcome measure is the stone-free rate after two and twelve weeks, considered as the absence of a stone ≥ 4 mm. Secondary outcome measures include pain after 24 hours, need for re-ESWL, and need for surgery.
Before statistical analysis, adjudication of all measurements will be done by an experienced statistician outside of the research group. The adjudicator will assess the quality of each measurement and will exclude those with inadequate quality from the analysis, where they will be regarded as missing. Once the adjudication process is complete, the finalized database will be unblinded.
Data will be kept anonymous until analysis, which is to be performed by an independent statistician external to the research group. Data are analyzed using SPSS version 25 (IBM, Armonk, NY, USA). Quantitative variables will be compared using the independent t-test or Mann-Whitney U test as appropriate. Qualitative variables will be compared with the chi-squared test or Fisher's exact test as appropriate. Logistic regression will be used to compare the likelihood of success between the study groups after controlling for study variables. P-values below 0.05 indicate statistical significance in all cases.
The study's executive committee will report any adverse events to an independent Data and Safety and Monitoring Board (DSMB). The DSMB will halt the trial if patient safety is compromised or if the primary research objective is met. The DSMB will monitor all safety issues, and the DSMB statistician will report safety problems in each study group monthly. Any deaths will be investigated.
The Ethics Committee of Shiraz University of Medical Sciences approved the study protocol (code: IR.SUMS.MED.REC.1399.085). Informed consent will be obtained from all patients while they are clinically stable and not under the influence of sedatives. All participants are able to withdraw from the study at any point. Given that furosemide does not adversely affect patients who do not have cardiovascular or renal diseases, no complications were predicted. The principles of the Declaration of Helsinki will be upheld throughout this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 500 patients will be randomly and equally divided into the intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Furosemide 40 mg, Other: Conventional Treatment40 mg of furosemide IV + IV midazolam + 1000 ml of normal saline 30 minutes before ESWL + Standard ESWL |
| Control Group | Active comparator | Other: Conventional TreatmentIV midazolam + 1000 ml of normal saline 30 minutes before ESWL + Standard ESWL |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 60 years
- Patients with renal or ureteral calculi referred by attending urologists to the ESWL Clinic of Shahid Faghihi Hospital, affiliated to Shiraz University of Medical Sciences (Shiraz, Iran)
Key exclusion criteria (12 listed)
- An anatomic anomaly in urinary system
- Coagulopathy
- Untreated urinary tract infection
- Prior urologic surgery
- Simultaneous unilateral renal and ureteral stones
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 |
|---|---|---|
| Furosemide 40 mgStandard ESWL + Furosemide 40 mg | Drug | Intervention Group |
| Conventional TreatmentStandard ESWL | Other | Control Group, Intervention Group |
Primary outcome
Stone-free rate
Time frame: 2 weeks after intervention
The absence of a stone ≥ 4 mm
Stone-free rate
Time frame: 3 months after intervention
The absence of a stone ≥ 4 mm
3 secondary outcomes
Renal colic on VAS of 0-10
Time frame: 24 hours after intervention
Number of participants with need for re-ESWL
Time frame: Within 3 months after intervention
Number of participants with need for surgery
Time frame: Within 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 30364478Liu Y, Chen Y, Liao B, Luo D, Wang K, Li H, Zeng G. Epidemiology of urolithiasis in Asia. Asian J Urol. 2018 Oct;5(4):205-214. doi: 10.1016/j.ajur.2018.08.007. Epub 2018 Sep 6.
- Background: PubMed 17361397Safarinejad MR. Adult urolithiasis in a population-based study in Iran: prevalence, incidence, and associated risk factors. Urol Res. 2007 Apr;35(2):73-82. doi: 10.1007/s00240-007-0084-6. Epub 2007 Mar 15.
- Background: PubMed 18825621Ketabchi AA, Aziziolahi GA. Prevalence of symptomatic urinary calculi in Kerman, Iran. Urol J. 2008 Summer;5(3):156-60.
- Background: PubMed 19521794Basiri A, Shakhssalim N, Khoshdel AR, Ghahestani SM, Basiri H. The demographic profile of urolithiasis in Iran: a nationwide epidemiologic study. Int Urol Nephrol. 2010 Mar;42(1):119-26. doi: 10.1007/s11255-009-9588-z. Epub 2009 Jun 12.
- Background: PubMed 29234530Sabharwal S, Jeyaseelan L, Panda A, Gnanaraj L, Kekre NS, Devasia A. A prospective randomised double-blind placebo-controlled trial to assess the effect of diuretics on shockwave lithotripsy of calculi. Arab J Urol. 2017 Jul 8;15(4):289-293. doi: 10.1016/j.aju.2017.04.003. eCollection 2017 Dec.
- Background: PubMed 24453399Hosseini MM, Shakeri S, Manaheji F, Aminsharifi A, Ezatzadegan S, Pakfetrat M, Basiratnia M, Hosseini M. Stone composition in patients who undergo renal stone surgery: review of 423 stone analyses in southern iran. Iran J Med Sci. 2014 Jan;39(1):75-6. No abstract available.
- Background: PubMed 21369388McAdams S, Shukla AR. Pediatric extracorporeal shock wave lithotripsy: Predicting successful outcomes. Indian J Urol. 2010 Oct;26(4):544-8. doi: 10.4103/0970-1591.74457.
- Background: PubMed 12201937Azm TA, Higazy H. Effect of diuresis on extracorporeal shockwave lithotripsy treatment of ureteric calculi. Scand J Urol Nephrol. 2002;36(3):209-12. doi: 10.1080/003655902320131893.
- Background: PubMed 18445899Zomorrodi A, Golivandan J, Samady J. Effect of diuretics on ureteral stone therapy with extracorporeal shock wave lithotripsy. Saudi J Kidney Dis Transpl. 2008 May;19(3):397-400.
- Background: PubMed 31723445Sohu S, Soomro MH, Mangrio RH, Shaikh AA, Mirani A, Chand K, Jalbani MH. Efficacy of extracorporeal shockwave lithotripsy with furosemide and hydration in renal stone management: A randomised controlled trial. Arab J Urol. 2019 Jul 24;17(4):279-284. doi: 10.1080/2090598X.2019.1645262. eCollection 2019.
- Individual participant dataSharing planned: Yes. Yes We plan to publish the study protocol soon. The final results will be published in the form of an article after the study is completed.
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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.
Dariush Irani, MD study director
Department of Urology, School of Medicine, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide 40 mg and Conventional Treatment in people with Urolithiasis and Nephrolithiasis, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyed Hossein Hosseini, MD (+989177016614, shhosseini_6687@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (time frame: 2 weeks after intervention). 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?
On the ClinicalTrials.gov record for NCT05270421, which also lists 10 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 8 Mar 2022.