Stone, UrinaryNCT07052188
Effect of Preop Stent Duration on SFR and Secondary Intervention in RIRS
A study testing without any preoperative stenting, (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks and Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. in people with Stone, Urinary and Stone, Kidney, run by Bedreddin Kalyenci at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate how placing a stent before surgery (preoperative stenting or passive dilation) affects the success rate of retrograde intrarenal surgery (RIRS), which is performed for kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone, Urinary, Stone, Kidney
- What is being tested?
- without any preoperative stenting, (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks and Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2025to 28 Mar 2026
- 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 over 18 years of age with an indication for RIRS (Retrograde Intrarenal Surgery)
Who cannot join
- Patients under 18 or over 65 years of age
- Patients who cannot be followed up in the postoperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Preoperative Stenting Duration on Stone-Free Rates and the Need for Secondary Surgical Intervention in Retrograde Intrarenal Surgery
This study aims to evaluate how placing a stent before surgery (preoperative stenting or passive dilation) affects the success rate of retrograde intrarenal surgery (RIRS), which is performed for kidney stones. Specifically, we will examine whether stenting improves the chance of becoming stone-free after surgery and reduces the need for a second surgical procedure.
- Conditions
- Stone, Urinary, Stone, Kidney
- Being tested
- without any preoperative stenting, (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks, Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.
- Keywords
- Ureteral stent, retrograde intrarenal surgery, prestenting, preoperative ureteral stenting
- Medical subject headings
- Urinary Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without any preoperative stentingProcedure or surgery
Patients will have RIRS without any preoperative stenting.
(DJ) stent placed with sedation and undergo RIRS within 2-4 weeksProcedure or surgery
Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks.
Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.Procedure or surgery
Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients will have RIRS without any preoperative double J (DJ) stenting | Experimental | Not described Receives: Procedure: without any preoperative stenting |
| Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks. | Experimental | Not described Receives: Procedure: (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks |
| Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. | Experimental | Not described Receives: Procedure: Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with stone-free
Measured: in the first month after surgery
Number of Participants with additional surgery was needed
Measured: in the first month after surgery
Secondary outcomes (1)
Number of Participants with postoperative complications
Measured: within 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start26 Jun 2025
- Primary completion15 Feb 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone, UrinaryStudies 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bedreddin Kalyenci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bedreddin Kalyenci, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052188
- Sponsor's protocol ID
- HRÜ/24.21.46
- Status last verified
- May 2026
- First submitted
- 26 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Preoperative Stenting Duration on Stone-Free Rates and the Need for Secondary Surgical Intervention in Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT07052188
- Acronym / sponsor ID
- HRÜ/24.21.46
- Conditions
- Stone, Urinary, Stone, Kidney
- Keywords
- Ureteral stent, retrograde intrarenal surgery, prestenting, preoperative ureteral stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Bedreddin KalyenciUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 4 Jul 2025 (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 evaluate how placing a stent before surgery (preoperative stenting or passive dilation) affects the success rate of retrograde intrarenal surgery (RIRS), which is performed for kidney stones. Specifically, we will examine whether stenting improves the chance of becoming stone-free after surgery and reduces the need for a second surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients will have RIRS without any preoperative double J (DJ) stenting | Experimental | Procedure: without any preoperative stenting |
| Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks. | Experimental | Procedure: (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks |
| Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. | Experimental | Procedure: Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. |
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 over 18 years of age with an indication for RIRS (Retrograde Intrarenal Surgery)
Key exclusion criteria (2 listed)
- Patients under 18 or over 65 years of age
- Patients who cannot be followed up in the postoperative period
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 |
|---|---|---|
| without any preoperative stentingPatients will have RIRS without any preoperative stenting. | Procedure or surgery | Patients will have RIRS without any preoperative double J (DJ) stenting |
| (DJ) stent placed with sedation and undergo RIRS within 2-4 weeksPatients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks. | Procedure or surgery | Patients will have a double-J (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks. |
| Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks.Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks | Procedure or surgery | Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. |
Primary outcome
Number of Participants with stone-free
Time frame: in the first month after surgery
Number of Participants with additional surgery was needed
Time frame: in the first month after surgery
1 secondary outcome
Number of Participants with postoperative complications
Time frame: within 1 month after surgery
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 13 May 2026.
- Individual participant dataSharing planned: Yes
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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 without any preoperative stenting, (DJ) stent placed with sedation and undergo RIRS within 2-4 weeks and Patients will have a DJ stent placed with sedation and undergo RIRS within 4-6 weeks. in people with Stone, Urinary and Stone, Kidney, run by Bedreddin Kalyenci at 1 site in Turkey (Türkiye).
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 2 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 13 May 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 Turkey (Türkiye). 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 Participants with stone-free (time frame: in the first month after surgery). 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?
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 13 May 2026.