Renal StoneNCT05833386
Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion
A study testing Ureteral access sheath placement during flexible ureteroscope for renal stones in people with Renal Stone, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone
- What is being tested?
- Ureteral access sheath placement during flexible ureteroscope for renal stones
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Aug 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
- All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath
Who cannot join
- Paediatric age group (less than 18 year)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology department - AlAzhar university
Cairo
Mohamed F Salman, MD, +201111788996, Prof_mohamed_fawzy@yahoo.com
Mohamed F Salman, MD
About this study
Official title: Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion for Flexible Ureteroscope in Treating Renal Stones; A Prospective, Multicentre, Randomized Trial
The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery.
Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm.
Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²
- Conditions
- Renal Stone
- Being tested
- Ureteral access sheath placement during flexible ureteroscope for renal stones
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral access sheath placement during flexible ureteroscope for renal stonesProcedure or surgery
Ureteral access sheath placement during flexible ureteroscope
| Study group | Role | What they receive |
|---|---|---|
| Silodosin group | Active comparator | all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery Receives: Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones |
| Non premedicated group | Active comparator | None of this group will receive alpha blocker prior to surgery Receives: Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate of UAS insertion during FURS
Measured: 2 hours
Secondary outcomes (3)
Ureteral injuries after UAS insertion
Ureter wall injury will be classified according to the following five grades:
Grade 0: No lesion or only mucosal petechiae. Grade 1: Mucosal erosion or a mucosal flap without smooth muscle injury. Grade 2: Erosion involving the mucosa and smooth muscle but sparing the adventitia.
Grade 3: Ureteral perforation involving the full thickness of the ureteral wall, including the adventitia.
Grade 4: Total ureteral avulsion with a complete rupture of ureteral continuity.
Measured: 3 hours
Post operative pain
a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery.
Measured: 12 hours after surgery
Complications related to the procedure
will be graded using the modified Clavien-Dindo classification system.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Oct 2022
- Primary completion1 May 2026 (estimated)
- Study completion1 Aug 2026 (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 Renal StoneStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University, Alexandria University, Cairo University, Menoufia University, Tanta University
- Responsible party
- Principal investigator, Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833386
- Sponsor's protocol ID
- pre-FURS sildosin
- Status last verified
- Aug 2023
- First submitted
- 16 Apr 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koo KC, Yoon JH, Park NC, Lee HS, Ahn HK, Lee KS, Kim DK, Cho KS, Chung BH, Hong CH. The Impact of Preoperative alpha-Adrenergic Antagonists on Ureteral Access Sheath Insertion Force and the Upper Limit of Force Required to Avoid Ureteral Mucosal Injury: A Randomized Controlled Study. J Urol. 2018 Jun;199(6):1622-1630. doi: 10.1016/j.juro.2017.09.173. Epub 2018 Feb 2.
PubMed 29410081Kim JK, Choi CI, Lee SH, Han JH, Shim YS, Choo MS; Young Endourological Study group. Silodosin for Prevention of Ureteral Injuries Resulting from Insertion of a Ureteral Access Sheath: A Randomized Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):572-579. doi: 10.1016/j.euf.2021.03.009. Epub 2021 Mar 23.
PubMed 33741297Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
PubMed 22982421
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion for Flexible Ureteroscope in Treating Renal Stones; A Prospective, Multicentre, Randomized Trial
- ClinicalTrials.gov ID
- NCT05833386
- Acronym / sponsor ID
- pre-FURS sildosin
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University, Alexandria University, Cairo University, Menoufia University, Tanta University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 27 Apr 2023 (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 ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery.
Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm.
Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin group | Active comparator | Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stonesall patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery |
| Non premedicated group | Active comparator | Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stonesNone of this group will receive alpha blocker prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath
Key exclusion criteria (1 listed)
- Paediatric age group (less than 18 year)
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 |
|---|---|---|
| Ureteral access sheath placement during flexible ureteroscope for renal stonesUreteral access sheath placement during flexible ureteroscope | Procedure or surgery | Non premedicated group, Silodosin group |
Primary outcome
failure rate of UAS insertion during FURS
Time frame: 2 hours
3 secondary outcomes
Ureteral injuries after UAS insertion
Time frame: 3 hours
Post operative pain
Time frame: 12 hours after surgery
Complications related to the procedure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 29410081Koo KC, Yoon JH, Park NC, Lee HS, Ahn HK, Lee KS, Kim DK, Cho KS, Chung BH, Hong CH. The Impact of Preoperative alpha-Adrenergic Antagonists on Ureteral Access Sheath Insertion Force and the Upper Limit of Force Required to Avoid Ureteral Mucosal Injury: A Randomized Controlled Study. J Urol. 2018 Jun;199(6):1622-1630. doi: 10.1016/j.juro.2017.09.173. Epub 2018 Feb 2.
- Background: PubMed 33741297Kim JK, Choi CI, Lee SH, Han JH, Shim YS, Choo MS; Young Endourological Study group. Silodosin for Prevention of Ureteral Injuries Resulting from Insertion of a Ureteral Access Sheath: A Randomized Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):572-579. doi: 10.1016/j.euf.2021.03.009. Epub 2021 Mar 23.
- Background: PubMed 22982421Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral access sheath placement during flexible ureteroscope for renal stones in people with Renal Stone, run by Al-Azhar 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 1 inclusion and 1 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 Aug 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure rate of UAS insertion during FURS (time frame: 2 hours). 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 NCT05833386, 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 8 Aug 2023.