FURSNCT05798572
Pre-Op Sildosine and Ureteral Dilation During F-URS
A study testing Sildosin group in people with FURS and Ureteral Dilatation, run by Benha University at 1 site in Egypt.
Trial summary
We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- FURS, Ureteral Dilatation, Sildosine
- What is being tested?
- Sildosin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Mar 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
- 2. Non stented.
- Age (Above 18 years old).
Who cannot join
- Acute or chronic renal insufficiency.
- Uncorrected coagulopathy.
- Previous open (lumber or ureteric) surgery.
- Active urinary tract infection unless treated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?
We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.
Read the detailed description
Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.
The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.
- Conditions
- FURS, Ureteral Dilatation, Sildosine
- Being tested
- Sildosin group, Placebo/control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildosin groupDrug
Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.
Placebo/control groupProcedure or surgery
included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| Sildosin group | Experimental | included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week. Receives: Drug: Sildosin group |
| Placebo/control group | Experimental | included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets. Receives: Procedure: Placebo/control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Entrance to bladder time (ETBT)
Entrance to bladder time (ETBT) will be recorded
Measured: Intraoperatively
Secondary outcomes (2)
Entrance to ureteric orifice time (ETUOT)
Entrance to ureteric orifice time (ETUOT) will be recorded
Measured: Intraoperatively
Application of access sheath time (AAST)
Application of access sheath time (AAST) will be recorded
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FURSStudies of the same condition, open and under way.
- More trials run by Benha 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abd El-Wahab Diab, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798572
- Sponsor's protocol ID
- Ms: 7-12-2022
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available under a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?
- ClinicalTrials.gov ID
- NCT05798572
- Acronym / sponsor ID
- Ms: 7-12-2022
- Conditions
- FURS, Ureteral Dilatation, Sildosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 4 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.
We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.
Detailed description
Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.
The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildosin group | Experimental | Drug: Sildosin groupincluded 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week. |
| Placebo/control group | Experimental | Procedure: Placebo/control groupincluded 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
- 2. Non stented.
- Age (Above 18 years old).
Key exclusion criteria (4 listed)
- Acute or chronic renal insufficiency.
- Uncorrected coagulopathy.
- Previous open (lumber or ureteric) surgery.
- Active urinary tract infection unless treated.
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 |
|---|---|---|
| Sildosin groupPatients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week. | Drug | Sildosin group |
| Placebo/control groupincluded 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets. | Procedure or surgery | Placebo/control group |
Primary outcome
Entrance to bladder time (ETBT)
Time frame: Intraoperatively
Entrance to bladder time (ETBT) will be recorded
2 secondary outcomes
Entrance to ureteric orifice time (ETUOT)
Time frame: Intraoperatively
Application of access sheath time (AAST)
Time frame: Intraoperatively
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 11 Jul 2023.
- Individual participant dataSharing planned: Yes. The study will be available under a reasonable request from the corresponding author.
Related trials for FURS
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6.3Fr Versus 7.5Fr Mini-Flexible Ureteroscopy for Renal Stones (MINI-FURS)
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A Study on the Application of NE Irrigation Fluid for Hemostasis in Flexible Ureteroscopic Lithotripsy: A Prospective Single-arm Interventional Study of Upper Urinary Tract Calculi.(NE: Norepinephrine)
Urolithiasis, Lithotripsy
Not yet recruitingObservational study
Predicting the Success of Flexible Ureterorenoscopy for Kidney and Upper Ureter Stones
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Not yet recruiting
FANS vs Standard Ureteral Access Sheath in fURS
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Not yet recruiting
Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm
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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 Sildosin group in people with FURS and Ureteral Dilatation, run by Benha 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 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 11 Jul 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?
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?
Entrance to bladder time (ETBT) (time frame: Intraoperatively). 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 11 Jul 2023.