Ureteric StoneNCT06761378
Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease
A study testing Renal stent and Flexible uretroscopy in people with Ureteric Stone, run by Menoufia University at 1 site in Egypt.
Trial summary
The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ureteric Stone
- What is being tested?
- Renal stent and Flexible uretroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 4 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with stone kidney up to 2 cm
- failed ESWL (extracorporeal shock wave lithotripsy)
- difficult PCNL (percutaneous nephrolithotomy)
Who cannot join
- Size more than 2 cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease , Two vs Four Weeks Prospective Study
The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion
Read the detailed description
The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion
- Conditions
- Ureteric Stone
- Being tested
- Renal stent, Flexible uretroscopy
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal stentProcedure or surgery
Renal stent before flexible uretroscopy
Flexible uretroscopyDevice
Renal stent for 2 weeks prior flexible uretroscopy
| Study group | Role | What they receive |
|---|---|---|
| 2 weeks Dj insertion | Active comparator | Renal stent for 2 weeks prior flexible uretroscopy Receives: Procedure: Renal stent; Device: Flexible uretroscopy |
| 4weeks Dj insertion | Active comparator | Renal stent for 4 weeks prior flexible uretroscopy Receives: Procedure: Renal stent; Device: Flexible uretroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks
Patients will classified in two groups, one will insert DJ for two weeks and the other insert DJ for four weeks then remove it and trial to insert access sheath for flexible uretroscopy duriing passage of the sheath the ureteric dilitation will be assessed if the sheath pass or not measure so , the ability of the ureteric dilitation to obtain the sheath is it dilated enough after 2 or 4 weeks
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteric StoneStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Model description
- Patients and methods The study will be conducted at the urology departments at Menoufia University hospitals. Inclusion criteria: - All patients with stone kidney up to 2 cm, failed ESWL , difficult PCNL Exclusion criteria: - Size more than 2 cm Preoperative assessment by ✓ Full History • personal history ( name ,age ,sex ,residence , occupation , special habits ) • complain • past medical • Past surgical history • family history ✓ Investigations including - laboratory investigations(urine analysis ,CBC ,PT ,AST ,ALT ,Urea, S.creatinine, RBS - Imaging ( CT Urography , KUB) Operative : - Stenting either two weeks or four weeks - Feasibility of Usage of axis sheath - Operative Time - Stone residual - Stent postoperative Disposable flexible URS - Durability - Cost effectiveness Post operative : - complications
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Kandeel, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761378
- Sponsor's protocol ID
- 5/2024UROL2
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salman B, Badawy A, El-Shazly M, Alorabi A, Elgharbawy M. Two versus four weeks ureteral stenting prior to flexible ureteroscopy after failed primary ureteral access sheath insertion: a randomized trial. BMC Urol. 2026 Jul 16;26(1):169. doi: 10.1186/s12894-026-02244-9.
PubMed 42464249
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease , Two vs Four Weeks Prospective Study
- ClinicalTrials.gov ID
- NCT06761378
- Acronym / sponsor ID
- 5/2024UROL2
- Conditions
- Ureteric Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 7 Jan 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 miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion
Detailed description
The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients and methods The study will be conducted at the urology departments at Menoufia University hospitals. Inclusion criteria: - All patients with stone kidney up to 2 cm, failed ESWL , difficult PCNL Exclusion criteria: - Size more than 2 cm Preoperative assessment by ✓ Full History • personal history ( name ,age ,sex ,residence , occupation , special habits ) • complain • past medical • Past surgical history • family history ✓ Investigations including - laboratory investigations(urine analysis ,CBC ,PT ,AST ,ALT ,Urea, S.creatinine, RBS - Imaging ( CT Urography , KUB) Operative : - Stenting either two weeks or four weeks - Feasibility of Usage of axis sheath - Operative Time - Stone residual - Stent postoperative Disposable flexible URS - Durability - Cost effectiveness Post operative : - complications
| Arm | Type | Receives |
|---|---|---|
| 2 weeks Dj insertion | Active comparator | Procedure: Renal stent, Device: Flexible uretroscopyRenal stent for 2 weeks prior flexible uretroscopy |
| 4weeks Dj insertion | Active comparator | Procedure: Renal stent, Device: Flexible uretroscopyRenal stent for 4 weeks prior flexible uretroscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients with stone kidney up to 2 cm
- failed ESWL (extracorporeal shock wave lithotripsy)
- difficult PCNL (percutaneous nephrolithotomy)
Key exclusion criteria (1 listed)
- Size more than 2 cm
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 |
|---|---|---|
| Renal stentRenal stent before flexible uretroscopy | Procedure or surgery | 2 weeks Dj insertion, 4weeks Dj insertion |
| Flexible uretroscopyRenal stent for 2 weeks prior flexible uretroscopy | Device | 2 weeks Dj insertion, 4weeks Dj insertion |
Primary outcome
passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks
Time frame: 6 months
Patients will classified in two groups, one will insert DJ for two weeks and the other insert DJ for four weeks then remove it and trial to insert access sheath for flexible uretroscopy duriing passage of the sheath the ureteric dilitation will be assessed if the sheath pass or not measure so , the ability of the ureteric dilitation to obtain the sheath is it dilated enough after 2 or 4 weeks
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 7 Jan 2025.
- Derived from this study: PubMed 42464249Salman B, Badawy A, El-Shazly M, Alorabi A, Elgharbawy M. Two versus four weeks ureteral stenting prior to flexible ureteroscopy after failed primary ureteral access sheath insertion: a randomized trial. BMC Urol. 2026 Jul 16;26(1):169. doi: 10.1186/s12894-026-02244-9.
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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 Renal stent and Flexible uretroscopy in people with Ureteric Stone, run by Menoufia 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 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: finished, as of the sponsor's last update on 7 Jan 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. 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?
passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks (time frame: 6 months). 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 NCT06761378, which also lists 1 linked publication.
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 7 Jan 2025.