Stone UreterNCT07068087
Silodosin in Facilitating Flexible Uretroscopy
A study testing Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS in people with Stone Ureter and Stone, Kidney, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stone Ureter, Stone, Kidney
- What is being tested?
- Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Sep 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult male or female
- single renal or ureteric stone
- 1 to 2 cm in size.
Who cannot join
- pregnant women
- Untreated urinary tract infections
- Uncorrected bleeding disorders or coagulopathies
- Bilateral ureteric stones or multiple ipsilateral ureteric stones
- ureteral stricture,
- Patients who had previous ureteric stenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pre-operative Silodosin on Facilitating Insertion of Ureteral Access SheathPrior to Retrograde Intra Renal Surgery: A Randomized Controlled Study
This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.
Read the detailed description
This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.
- Conditions
- Stone Ureter, Stone, Kidney
- Being tested
- Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS, ureteric access sheath insertion in RIRS without silodosin (Placebo)
- Keywords
- Retrograde Intra Renal Surgery (RIRS), Flexible uretroscopy, Laser disintegration, Alpha blocker selective, Silodosin
- Medical subject headings
- Ureterolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRSProcedure or surgery
group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively
ureteric access sheath insertion in RIRS without silodosin (Placebo)Procedure or surgery
group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Receiving Sioldosin 8 mg prior to intervention | Active comparator | Not described Receives: Procedure: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS |
| Receiving Placebo prior to intervention | Placebo comparator | Not described Receives: Procedure: ureteric access sheath insertion in RIRS without silodosin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess success of ureteric access sheath placement.
assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.
Measured: during the operation in the OR
Secondary outcomes (3)
Operative time
Measured: from time of induction of anaesthesia in surgery till the end of procedure.
Cost of the procedure
Overall cost of each procedure included cost of standard procedure of flexible URS added to cost of medication prior to operations. If any case needed ureteral dilatation, the cost of dilators was added. Also, in case of complications occurred, additional cost of management of these complications was added. Finally, in cases of failed UAS insertion, the cost of auxiliary procedure was added. Cost was calculated initially in Egyptian pounds and was converted to U.S dollars for standardization.
Measured: from admission and through study completion
complications
Assess postoperativePain, fever and Residual stones
Measured: Perioperative and up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Feb 2025
- Primary completion10 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stone UreterStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younan Ramsis, Ain Shams University
- Investigators
- Mahmoud A. Mohammed, M.D., Study chair, Ain Shams UniversityYounan R. Samir, M.D., Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068087
- Sponsor's protocol ID
- FMASU MS 766/2024
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benedict, A., Rajenthiran, V., & Eswaramurthy, A. (2021). Effects of silodosin, darifenacin, and combination therapy for the treatment of ureteral stent related discomforts. International Surgery Journal, 8(10), 3031-3035.
Alsaikhan B, Koziarz A, Lee JY, Pace KT. Preoperative Alpha-Blockers for Ureteroscopy for Ureteral Stones: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Endourol. 2020 Jan;34(1):33-41. doi: 10.1089/end.2019.0520. Epub 2019 Oct 9.
PubMed 31507224Alaridy, H. M., Zwain, K. M. A., Al-Mosawi, H. Q., & Hadi, N. R. (2020). Comparison of silodosin, tadalafil and combinations prior to ureteroscopic management of ureteral stones. Systematic Reviews in Pharmacy, 11(4), 238-242.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pre-operative Silodosin on Facilitating Insertion of Ureteral Access SheathPrior to Retrograde Intra Renal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07068087
- Acronym / sponsor ID
- FMASU MS 766/2024
- Conditions
- Stone Ureter, Stone, Kidney
- Keywords
- Retrograde Intra Renal Surgery (RIRS), Flexible uretroscopy, Laser disintegration, Alpha blocker selective, Silodosin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 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 provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.
Detailed description
This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving Sioldosin 8 mg prior to intervention | Active comparator | Procedure: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS |
| Receiving Placebo prior to intervention | Placebo comparator | Procedure: ureteric access sheath insertion in RIRS without silodosin (Placebo) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adult male or female
- single renal or ureteric stone
- 1 to 2 cm in size.
Key exclusion criteria (6 listed)
- pregnant women
- Untreated urinary tract infections
- Uncorrected bleeding disorders or coagulopathies
- Bilateral ureteric stones or multiple ipsilateral ureteric stones
- ureteral stricture,
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 |
|---|---|---|
| Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRSgroup A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively | Procedure or surgery | Receiving Sioldosin 8 mg prior to intervention |
| ureteric access sheath insertion in RIRS without silodosin (Placebo)group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively | Procedure or surgery | Receiving Placebo prior to intervention |
Primary outcome
Assess success of ureteric access sheath placement.
Time frame: during the operation in the OR
assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.
3 secondary outcomes
Operative time
Time frame: from time of induction of anaesthesia in surgery till the end of procedure.
Cost of the procedure
Time frame: from admission and through study completion
complications
Time frame: Perioperative and up to 24 weeks
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 16 Jul 2025.
- BackgroundBenedict, A., Rajenthiran, V., & Eswaramurthy, A. (2021). Effects of silodosin, darifenacin, and combination therapy for the treatment of ureteral stent related discomforts. International Surgery Journal, 8(10), 3031-3035.
- Background: PubMed 31507224Alsaikhan B, Koziarz A, Lee JY, Pace KT. Preoperative Alpha-Blockers for Ureteroscopy for Ureteral Stones: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Endourol. 2020 Jan;34(1):33-41. doi: 10.1089/end.2019.0520. Epub 2019 Oct 9.
- BackgroundAlaridy, H. M., Zwain, K. M. A., Al-Mosawi, H. Q., & Hadi, N. R. (2020). Comparison of silodosin, tadalafil and combinations prior to ureteroscopic management of ureteral stones. Systematic Reviews in Pharmacy, 11(4), 238-242.
- Individual participant dataSharing planned: No
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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.
Mahmoud A. Mohammed, M.D. study chair
Ain Shams University
Younan R. Samir, M.D. study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS in people with Stone Ureter and Stone, Kidney, run by Ain Shams 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 6 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 16 Jul 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 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. Some participants in this study may receive a placebo. 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?
Assess success of ureteric access sheath placement. (time frame: during the operation in the OR). 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 NCT07068087, which also lists 3 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 16 Jul 2025.