UrolithiasisNCT07202923
Effect of Preoperative Alpha-blockers on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-prestented Patients During RIRS. Assessment of Factors for Successful Ureteral Access Sheath Insertion.
An observational study of Urolithiasis and Ureteral Injury, run by St. Luke's Clinical Hospital, Russia at 1 site in Russia.
Trial summary
The aim of the study is to evaluate the effect of preoperative taking alpha-blockers (tamsulosin or silodosin) on the success rate of ureteral access sheath (UAS) insertion and the degree of ureteral injury during RIRS in non-prestented patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Ureteral Injury, Ureteral Access Sheath
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jul 2021to 2 Jun 2024
- Phase
- Observational
- 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
Study population: This is an interventional RCT. Population characteristics are described in Eligibility Criteria and Arms sections
Who may be able to join
- Patients aged 18 years and older
- Kidney stone size: ≤2 cm
- Stone density >1000 Hounsfield units
- Sterile urine culture
Who cannot join
- Congenital anomalies of the urinary tract
- Urinary tract infections
- Upper urinary tract obstruction
- Prior reconstructive surgeries on the upper urinary tract
Trial locations and contacts
1 site in 1 country.
Russia1 site
St. Luke's Clinical Hospital
Saint Petersburg, Outside U.S./Canada
About this study
Official title: Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of Factors for Successful Ureteral Access Sheath Insertion. Randomized Clinical Trial.
The aim of the study is to evaluate the effect of preoperative taking alpha-blockers (tamsulosin or silodosin) on the success rate of ureteral access sheath (UAS) insertion and the degree of ureteral injury during RIRS in non-prestented patients.
The results showed that patients who received alpha-blockers had a higher rate of successful UAS insertion and a lower degree of ureteral injury compared to non-prestented patients. In addition, patients with a BMI greater than 25 kg/m² and those older than 59 years demonstrated a higher success rate of UAS insertion and lower degree of ureteral injury.
Read the detailed description
Study Title:
Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of factors for successful ureteral access sheath insertion. Randomized clinical trial.
Study Design:
Prospective, randomized, open-label, controlled trial with four parallel arms. Conducted from July 2021 to June 2024.
Study Center:
Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia
Study Population:
140 patients, divided into four equal groups of 35 people each: Group I (Tamsulosin): Non-prestented patients receiving 0.4 mg of Tamsulosin daily for 7 days before RIRS.
Group II (Silodosin): Non-prestented patients receiving 8 mg of Silodosin daily for 7 days before RIRS.
Group III: Prestented patients. Group IV: Control group (non-prestented patients)
Interventions:
All patients received antibiotic prophylaxis with third-generation cephalosporins 30 minutes before surgery.
RIRS was performed using disposable flexible ureteroscopes. The UAS diameter was 11/13 Fr. Thulium fiber laser was used for lithotripsy. Stone fragmentation was performed in dusting and fragmentation modes, with a total power not exceeding 20 W and a fiber thickness of 200 µm.
Statistical Analysis:
Data were analyzed using Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, and chi-square tests with Bonferroni correction (SPSS v26, JMP Pro 17). Statistical significance was set at p<0.05.
Key Findings:
Comparable baseline characteristics (p>0.05)
Significantly higher UAS success rates:
Tamsulosin: 31 (88.57%)
Silodosin: 32 (91.43%)
Prestented: 33 (94.29%)
Control: 62.86% (p=0.0008)
Preoperative taking Silodosin significantly reduced degree ureteral injury (p=0.0253).
Patients receiving alpha-blockers experienced less postoperative pain compared to the control group (p<0.0001) and less inflammatory changes in blood tests compared to prestented patients (WBC: p=0.0002; CRP: p<0.0001)
Patients with BMI ≥ 25 kg/m² and age ≥ 59 years had a higher success rate of UAS insertion (p<0,0001).
Patients with BMI ≥ 25 kg/m² and age ≥ 59 years have a lower degree of ureteral injury (p<0,0001).
Conclusions:
Preoperative taking of alpha-blockers (Tamsulosin or Silodosin) increases the success of UAS insertion.
Silodosin reduces the degree ureteral injury. Patients taking alpha-blockers less postoperative pain and inflammatory changes in blood tests.
A BMI ≥ 25 kg/m² and age ≥ 59 years increase the success of UAS insertion and reduce degree of ureteral injury
Clinical Implications:
This study provides evidence supporting the use of alpha-blockers, particularly silodosin, for passive ureteral dilation prior to RIRS in non-prestented patients, potentially reducing compications and improving patient outcomes.
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Tamsulosin) | Non-prestented patients receiving 0.4 mg of Tamsulosin daily for 7 days before RIRS. | |
| Group II (Silodosin) | Non-prestented patients receiving 8 mg of Silodosin daily for 7 days before RIRS. | |
| Group III | Prestented patients | |
| Group IV | Control group (non-prestented patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful of ureteral access sheath insertion
Proportion of patients with successful UAS insertion
Measured: Intraoperative
degree of ureteral injury
Assessed using the PULS scale.Post-Ureteral Lesion Scale. Grade 0: No injury - intact ureter with no visible damage. Grade 1: Superficial mucosal injury - minor abrasions or erosions without disruption of the ureteral wall.
Grade 2: Partial thickness injury - damage involving part of the ureteral wall, without full-thickness perforation; may have localized bleeding.
Grade 3: Full-thickness ureteral injury - perforation of the ureteral wall with urine leakage, but the injury is limited in size.
Grade 4: Extensive ureteral damage - large perforation with significant tissue destruction.
Grade 5: Complete transection or avulsion - full disruption with loss of ureteral tissue, typically requiring complex reconstructive surgery.
Measured: Perioperative
postoperative pain
Patient-reported pain intensity. The Visual Analog Scale for Pain (VASP) is a widely used, validated tool for the subjective measurement of pain intensity. It consists of a straight line, typically 10 centimeters (100 millimeters) in length, anchored by two verbal descriptors: "no pain" at the zero end and "worst imaginable pain" at the opposite end.
Participants rate their current pain level by marking a point along the line that corresponds to their perception of pain intensity. The distance from the zero point to the mark (measured in millimeters or centimeters) quantifies the pain intensity on a continuous scale from 0 to 10 (or 0 to 100).
Measured: 6, 24, and 48 hours postoperatively
Inflammatory markers
Change in in blood Leukocyte count, 10⁹/L C- reactive protein , mg/l
Measured: Baseline and 24 hours postoperatively
Factors influencing successful ureteral access sheath insertion
Multivariate analysis of factors influencing successful UAS insetion. BMI of the patient - kg/m² Age of the patient
Measured: Until the completion of the study, on average 1 year
Secondary outcomes (2)
Postoperative complications
Complications graded by Clavien-Dindo classification
Measured: through study completion, an average of 1 year
Operative time
total operative time
Measured: Intraoperative (measured from start to end of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start9 Jul 2021
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Clinical Hospital, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikheev Yury, St. Luke's Clinical Hospital, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202923
- Sponsor's protocol ID
- №19/2
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently finalizing our data sharing policy. All required individual participant data underlying the reported results will be made available for regulatory purposes immediately upon request, and may be shared with researchers following publication after de-identification, contingent on submission of a methodologically sound proposal and compliance with institutional and national privacy regulations
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of Factors for Successful Ureteral Access Sheath Insertion. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07202923
- Acronym / sponsor ID
- №19/2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- St. Luke's Clinical Hospital, RussiaUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 2 Oct 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.
The aim of the study is to evaluate the effect of preoperative taking alpha-blockers (tamsulosin or silodosin) on the success rate of ureteral access sheath (UAS) insertion and the degree of ureteral injury during RIRS in non-prestented patients.
The results showed that patients who received alpha-blockers had a higher rate of successful UAS insertion and a lower degree of ureteral injury compared to non-prestented patients. In addition, patients with a BMI greater than 25 kg/m² and those older than 59 years demonstrated a higher success rate of UAS insertion and lower degree of ureteral injury.
Detailed description
Study Title:
Effect of Preoperative Tamsulosin and Silodosin on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-Prestented Patients During Retrograde Intrarenal Surgery (RIRS). Assessment of factors for successful ureteral access sheath insertion. Randomized clinical trial.
Study Design:
Prospective, randomized, open-label, controlled trial with four parallel arms. Conducted from July 2021 to June 2024.
Study Center:
Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia
Study Population:
140 patients, divided into four equal groups of 35 people each: Group I (Tamsulosin): Non-prestented patients receiving 0.4 mg of Tamsulosin daily for 7 days before RIRS.
Group II (Silodosin): Non-prestented patients receiving 8 mg of Silodosin daily for 7 days before RIRS.
Group III: Prestented patients. Group IV: Control group (non-prestented patients)
Interventions:
All patients received antibiotic prophylaxis with third-generation cephalosporins 30 minutes before surgery.
RIRS was performed using disposable flexible ureteroscopes. The UAS diameter was 11/13 Fr. Thulium fiber laser was used for lithotripsy. Stone fragmentation was performed in dusting and fragmentation modes, with a total power not exceeding 20 W and a fiber thickness of 200 µm.
Statistical Analysis:
Data were analyzed using Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, and chi-square tests with Bonferroni correction (SPSS v26, JMP Pro 17). Statistical significance was set at p<0.05.
Key Findings:
Comparable baseline characteristics (p>0.05)
Significantly higher UAS success rates:
Tamsulosin: 31 (88.57%)
Silodosin: 32 (91.43%)
Prestented: 33 (94.29%)
Control: 62.86% (p=0.0008)
Preoperative taking Silodosin significantly reduced degree ureteral injury (p=0.0253).
Patients receiving alpha-blockers experienced less postoperative pain compared to the control group (p<0.0001) and less inflammatory changes in blood tests compared to prestented patients (WBC: p=0.0002; CRP: p<0.0001)
Patients with BMI ≥ 25 kg/m² and age ≥ 59 years had a higher success rate of UAS insertion (p<0,0001).
Patients with BMI ≥ 25 kg/m² and age ≥ 59 years have a lower degree of ureteral injury (p<0,0001).
Conclusions:
Preoperative taking of alpha-blockers (Tamsulosin or Silodosin) increases the success of UAS insertion.
Silodosin reduces the degree ureteral injury. Patients taking alpha-blockers less postoperative pain and inflammatory changes in blood tests.
A BMI ≥ 25 kg/m² and age ≥ 59 years increase the success of UAS insertion and reduce degree of ureteral injury
Clinical Implications:
This study provides evidence supporting the use of alpha-blockers, particularly silodosin, for passive ureteral dilation prior to RIRS in non-prestented patients, potentially reducing compications and improving patient outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (Tamsulosin) | – | –Non-prestented patients receiving 0.4 mg of Tamsulosin daily for 7 days before RIRS. |
| Group II (Silodosin) | – | –Non-prestented patients receiving 8 mg of Silodosin daily for 7 days before RIRS. |
| Group III | – | –Prestented patients |
| Group IV | – | –Control group (non-prestented patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an interventional RCT. Population characteristics are described in Eligibility Criteria and Arms sections
Key inclusion criteria (4 listed)
- Patients aged 18 years and older
- Kidney stone size: ≤2 cm
- Stone density >1000 Hounsfield units
- Sterile urine culture
Key exclusion criteria (4 listed)
- Congenital anomalies of the urinary tract
- Urinary tract infections
- Upper urinary tract obstruction
- Prior reconstructive surgeries on the upper urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
successful of ureteral access sheath insertion
Time frame: Intraoperative
Proportion of patients with successful UAS insertion
degree of ureteral injury
Time frame: Perioperative
Assessed using the PULS scale.Post-Ureteral Lesion Scale. Grade 0: No injury - intact ureter with no visible damage. Grade 1: Superficial mucosal injury - minor abrasions or erosions without disruption of the ureteral wall. Grade 2: Partial thickness injury - damage involving part of the ureteral wall, without full-thickness perforation; may have localized bleeding. Grade 3: Full-thickness ureteral injury - perforation of the ureteral wall with urine leakage, but the injury is limited in size. Grade 4: Extensive ureteral damage - large perforation with significant tissue destruction. Grade 5: Complete transection or avulsion - full disruption with loss of ureteral tissue, typically requiring complex reconstructive surgery.
postoperative pain
Time frame: 6, 24, and 48 hours postoperatively
Patient-reported pain intensity. The Visual Analog Scale for Pain (VASP) is a widely used, validated tool for the subjective measurement of pain intensity. It consists of a straight line, typically 10 centimeters (100 millimeters) in length, anchored by two verbal descriptors: "no pain" at the zero end and "worst imaginable pain" at the opposite end. Participants rate their current pain level by marking a point along the line that corresponds to their perception of pain intensity. The distance from the zero point to the mark (measured in millimeters or centimeters) quantifies the pain intensity on a continuous scale from 0 to 10 (or 0 to 100).
Inflammatory markers
Time frame: Baseline and 24 hours postoperatively
Change in in blood Leukocyte count, 10⁹/L C- reactive protein , mg/l
Factors influencing successful ureteral access sheath insertion
Time frame: Until the completion of the study, on average 1 year
Multivariate analysis of factors influencing successful UAS insetion. BMI of the patient - kg/m² Age of the patient
2 secondary outcomes
Postoperative complications
Time frame: through study completion, an average of 1 year
Operative time
Time frame: Intraoperative (measured from start to end of procedure)
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 24 Nov 2025.
- Complete study data is available upon formal request by email . All legitimate data inquiries will be processed in accordance with applicable privacy regulations.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are currently finalizing our data sharing policy. All required individual participant data underlying the reported results will be made available for regulatory purposes immediately upon request, and may be shared with researchers following publication after de-identification, contingent on submission of a methodologically sound proposal and compliance with institutional and national privacy regulations
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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?
An observational study of Urolithiasis and Ureteral Injury, run by St. Luke's Clinical Hospital, Russia at 1 site in Russia.
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 4 inclusion and 4 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 24 Nov 2025. 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 Russia. 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?
successful of ureteral access sheath insertion (time frame: Intraoperative). The study lists 5 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 24 Nov 2025.