Stone UreterNCT06722703
ESWL vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study
A study testing shock wave lithotripsy and Flexible ureteroscope lithotripsy in people with Stone Ureter, run by Assiut University.
Trial summary
This comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone Ureter
- What is being tested?
- shock wave lithotripsy and Flexible ureteroscope lithotripsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age>18 years old. Stone site: upper ureteric stone. Stone side: unilateral stones Stone size: stones diameter up to 1cm Stone number: single or multiple Radio-opaque stone
Who cannot join
- patients with solitary kidney or only function kidney renal impairment present of distal obstruction pregnancy, current breast feeding. Bleeding tendency or anticoagulation. ipsilateral ureterolithiasis, Acute or chronic nephritis, or Renal tuberculosis aneurysm of the aorta or renal artery. inability to position the patient on the SWL table (eg, due to severe skeletal deformity or morbid obesity).
- radiolucent stones that are not visible on ultrasound. severe metabolic disturbances (eg, cystinuria, primary hyperparathyroidism, or renal tubular acidosis)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. A thorough understanding of these techniques is essential for optimizing patient outcomes and personalizing treatment strategies.
study aim to evaluate the effectiveness, safety, and cost of SWL compared to flexible uretroscopy in management patients with upper ureteric stone less than 15 mm in size
Read the detailed description
The management of upper ureteric stones, particularly those less than 15 mm in size, has seen significant advancements with the development of minimally invasive techniques. Urolithiasis is a common condition, and selecting the most appropriate treatment is crucial for effective stone clearance and minimizing complications. Two widely used approaches in treating upper ureteric stones are Extracorporeal Shock Wave Lithotripsy (ESWL) and Flexible Ureteroscopy (FURS).
ESWL, a non-invasive procedure, uses focused shock waves to fragment the stone into smaller pieces that can be passed naturally through the urinary tract. Its non-invasiveness makes it an attractive option for many patients; however, its success is influenced by factors such as stone composition, location, and patient anatomy. In contrast, Flexible Ureteroscopy (FURS) is a minimally invasive endoscopic technique where a flexible ureteroscope is passed through the urinary tract to directly visualize and fragment the stone using a laser (usually a Holmium: YAG laser). This method allows for a more targeted approach and is often used when ESWL is less effective or contraindicated.
ESWL and FURS have distinct advantages and limitations, and the choice between them depends on factors including stone size, density, location, and patient-specific considerations such as body habitus and anatomical variations.
- Conditions
- Stone Ureter
- Being tested
- shock wave lithotripsy, Flexible ureteroscope lithotripsy
- Keywords
- upper ureteric stones, ESWL, 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.
shock wave lithotripsyProcedure or surgery
Extracorporeal shock wave lithotripsy will be performed using a third-generation electromagnetic lithotripter The focal depth is 110 mm; the focal area is 7 mm (radial) and 45-50 mm (axial), and the focal pressure is 6-30 MPa). The procedure is performed in a supine or prone position without anesthesia. Stone localization and simultaneous real-time monitoring during the process will be performed by ultrasound). The shock frequency is 60-90 (shock waves/min). The total number of shock waves applied for one session is between 1500 and 2500 waves, or the session is stopped at a significant stone fragmentation is detected. The voltage applied per session ranged from 10 to 16 kV with stepwise power ramping strategy. All procedures in the SWL group are outpatient procedures.
Flexible ureteroscope lithotripsyProcedure or surgery
All F-URS cases will be performed by a single surgeon (HMI). A guidewire is placed in the upper urinary tract through a rigid cystoscope under fluoroscopic guidance. An 8-10 F dual lumen catheter is used to dilate the intramural ureter and to fix a second guidewire with hydrophilic coat. The 7.5 F flexible ureteroscope is passed into the upper urinary tract in a monorail fashion over the second wire. A holmium-YAG laser is used at an energy setting of 0.8-1 J and a rate of 10-15 Hz. A 200 µm laser fibre is used for delivering laser energy to the stones. A 2.2 F tipless nitinol basket is used to displace the stones from the lower pole to an upper pole calyx before disintegration. Adequate fragmentation is considered when fragments are smaller than the diameter of the guide wire. Stone fragments will be left for spontaneous passage. At the end of the procedure, the whole collecting system will be inspected for residual stones and a double pigtail ureteric stent will be left for 2 weeks t
| Study group | Role | What they receive |
|---|---|---|
| ESWL group | Experimental | The surgical technique of shock wave lithotripsy |
| FURS group | Experimental | Flexible ureteroscope lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The stone-free rate (SFR)
The stone-free rate (SFR) is defined as no evidence of clinically significant stone fragments (≥ 4 mm in size) in combination with a plain X-ray of the urinary tract (KUB) and urinary ultrasound one month after SWL or F-URS
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stone UreterStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha Abdulrahim Bassery Bakhit, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722703
- Sponsor's protocol ID
- ESWL vs FURS UUS
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yuri P, Hariwibowo R, Soeroharjo I, Danarto R, Hendri AZ, Brodjonegoro SR, Rasyid N, Birowo P, Widyahening IS. Meta-analysis of Optimal Management of Lower Pole Stone of 10 - 20 mm: Flexible Ureteroscopy (FURS) versus Extracorporeal Shock Wave Lithotripsy (ESWL) versus Percutaneus Nephrolithotomy (PCNL). Acta Med Indones. 2018 Jan;50(1):18-25.
PubMed 29686172Jahrreiss V, Seitz C, Quhal F. Medical management of urolithiasis: Great efforts and limited progress. Asian J Urol. 2024 Apr;11(2):149-155. doi: 10.1016/j.ajur.2023.05.001. Epub 2023 Jun 29.
PubMed 38680579
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESWL vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06722703
- Acronym / sponsor ID
- ESWL vs FURS UUS
- Conditions
- Stone Ureter
- Keywords
- upper ureteric stones, ESWL, flexible uretroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Dec 2024 (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 comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. A thorough understanding of these techniques is essential for optimizing patient outcomes and personalizing treatment strategies.
study aim to evaluate the effectiveness, safety, and cost of SWL compared to flexible uretroscopy in management patients with upper ureteric stone less than 15 mm in size
Detailed description
The management of upper ureteric stones, particularly those less than 15 mm in size, has seen significant advancements with the development of minimally invasive techniques. Urolithiasis is a common condition, and selecting the most appropriate treatment is crucial for effective stone clearance and minimizing complications. Two widely used approaches in treating upper ureteric stones are Extracorporeal Shock Wave Lithotripsy (ESWL) and Flexible Ureteroscopy (FURS).
ESWL, a non-invasive procedure, uses focused shock waves to fragment the stone into smaller pieces that can be passed naturally through the urinary tract. Its non-invasiveness makes it an attractive option for many patients; however, its success is influenced by factors such as stone composition, location, and patient anatomy. In contrast, Flexible Ureteroscopy (FURS) is a minimally invasive endoscopic technique where a flexible ureteroscope is passed through the urinary tract to directly visualize and fragment the stone using a laser (usually a Holmium: YAG laser). This method allows for a more targeted approach and is often used when ESWL is less effective or contraindicated.
ESWL and FURS have distinct advantages and limitations, and the choice between them depends on factors including stone size, density, location, and patient-specific considerations such as body habitus and anatomical variations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWL group | Experimental | –The surgical technique of shock wave lithotripsy |
| FURS group | Experimental | –Flexible ureteroscope lithotripsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients age>18 years old. Stone site: upper ureteric stone. Stone side: unilateral stones Stone size: stones diameter up to 1cm Stone number: single or multiple Radio-opaque stone
Key exclusion criteria (2 listed)
- patients with solitary kidney or only function kidney renal impairment present of distal obstruction pregnancy, current breast feeding. Bleeding tendency or anticoagulation. ipsilateral ureterolithiasis, Acute or chronic nephritis, or Renal tuberculosis aneurysm of the aorta or renal artery. inability to position the patient on the SWL table (eg, due to severe skeletal deformity or morbid obesity).
- radiolucent stones that are not visible on ultrasound. severe metabolic disturbances (eg, cystinuria, primary hyperparathyroidism, or renal tubular acidosis)
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 |
|---|---|---|
| shock wave lithotripsyExtracorporeal shock wave lithotripsy will be performed using a third-generation electromagnetic lithotripter The focal depth is 110 mm; the focal area is 7 mm (radial) and 45-50 mm (axial), and the focal pressure is 6-30 MPa). The procedure is performed in a supine or prone position without anesthesia. Stone localization and simultaneous real-time monitoring during the process will be performed by ultrasound). The shock frequency is 60-90 (shock waves/min). The total number of shock waves applied for one session is between 1500 and 2500 waves, or the session is stopped at a significant stone fragmentation is detected. The voltage applied per session ranged from 10 to 16 kV with stepwise power ramping strategy. All procedures in the SWL group are outpatient procedures. | Procedure or surgery | – |
| Flexible ureteroscope lithotripsyAll F-URS cases will be performed by a single surgeon (HMI). A guidewire is placed in the upper urinary tract through a rigid cystoscope under fluoroscopic guidance. An 8-10 F dual lumen catheter is used to dilate the intramural ureter and to fix a second guidewire with hydrophilic coat. The 7.5 F flexible ureteroscope is passed into the upper urinary tract in a monorail fashion over the second wire. A holmium-YAG laser is used at an energy setting of 0.8-1 J and a rate of 10-15 Hz. A 200 µm laser fibre is used for delivering laser energy to the stones. A 2.2 F tipless nitinol basket is used to displace the stones from the lower pole to an upper pole calyx before disintegration. Adequate fragmentation is considered when fragments are smaller than the diameter of the guide wire. Stone fragments will be left for spontaneous passage. At the end of the procedure, the whole collecting system will be inspected for residual stones and a double pigtail ureteric stent will be left for 2 weeks t | Procedure or surgery | – |
Primary outcome
The stone-free rate (SFR)
Time frame: 1 month
The stone-free rate (SFR) is defined as no evidence of clinically significant stone fragments (≥ 4 mm in size) in combination with a plain X-ray of the urinary tract (KUB) and urinary ultrasound one month after SWL or F-URS
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 9 Dec 2024.
- Results publication: PubMed 29686172Yuri P, Hariwibowo R, Soeroharjo I, Danarto R, Hendri AZ, Brodjonegoro SR, Rasyid N, Birowo P, Widyahening IS. Meta-analysis of Optimal Management of Lower Pole Stone of 10 - 20 mm: Flexible Ureteroscopy (FURS) versus Extracorporeal Shock Wave Lithotripsy (ESWL) versus Percutaneus Nephrolithotomy (PCNL). Acta Med Indones. 2018 Jan;50(1):18-25.
- Results publication: PubMed 38680579Jahrreiss V, Seitz C, Quhal F. Medical management of urolithiasis: Great efforts and limited progress. Asian J Urol. 2024 Apr;11(2):149-155. doi: 10.1016/j.ajur.2023.05.001. Epub 2023 Jun 29.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave lithotripsy and Flexible ureteroscope lithotripsy in people with Stone Ureter, run by Assiut University.
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 2 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: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Taha Abdulrahim Bassery Bakhit, resident doctor (+2 01016766014, Bassrytaha123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The stone-free rate (SFR) (time frame: 1 month). 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 NCT06722703, which also lists 2 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 9 Dec 2024.