Ureter StoneNCT06101563
Duration Between Drainage and Ureteroscopic Lithotripsy
A study testing Early ureteroscopy and Delayed Ureteroscopy in people with Ureter Stone and Renal Stone, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will be conducted to compare early (seven days) versus delayed (14-21 days) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureter Stone, Renal Stone, Ureteric Obstruction
- What is being tested?
- Early ureteroscopy and Delayed Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstructing ureteral or renal stone <20 mm.
- Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS).
Who cannot join
- History of endoscopic instrumentation to the urinary tract in the last 4 weeks prior to presentation.
- Bilateral obstructed kidneys necessitating bilateral drainage.
- Associated emphysematous pyelonephritis or perinephric abscess.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Duration Between Drainage for Obstructing Renal or Ureteral Stones Associated With Infection and Ureteroscopic Lithotripsy: A Randomized Controlled Trial.
This study will be conducted to compare early (seven days) versus delayed (14-21 days) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.
Read the detailed description
All the study participants will be monitored during the early post-operative period for post-operative pain and complications. The rate and grade of reported complications will be determined according to modified Dindo-Clavian grading system. After ensuring safe status for discharge, all patients will be reassessed at the outpatient department after 4 weeks by NCCT to assess stone free status.
- Conditions
- Ureter Stone, Renal Stone, Ureteric Obstruction
- Being tested
- Early ureteroscopy, Delayed Ureteroscopy
- Keywords
- Ureteroscopy, Sepsis, infectious complications, ureteric calculi, Renal calculi
- Medical subject headings
- Ureterolithiasis, Nephrolithiasis, Ureteral Obstruction, Sepsis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ureteroscopyProcedure or surgery
Patients will be managed by ureteroscopic lithotripsy 7 days after drainage.
Delayed UreteroscopyProcedure or surgery
Patients will be managed by ureteroscopic lithotripsy 14-21 days after drainage.
| Study group | Role | What they receive |
|---|---|---|
| Early | Active comparator | Patients will be managed by ureteroscopic lithotripsy 7 days after drainage. Receives: Procedure: Early ureteroscopy |
| Delayed | Active comparator | Patients will be managed by ureteroscopic lithotripsy 14-21 days after drainage. Receives: Procedure: Delayed Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of postoperative infectious complications in treatment groups
Difference in post-URS infectious complications between the study groups. infectious complications are defined as presence of urinary tract infection with one of the following findings: - Body temperature more than 38.3C or below 36C. - Tachycardia (>90/minute). - Respiratory rate more than 20/minute. - Disturbed mental status. - Systolic blood pressure < 90 mmHg \& mean arterial pressure < 70 mmHg or systolic blood pressure decrease < 40 mmHg. - WBC >12,000 or <4,000.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 May 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 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 Ureter StoneStudies 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
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed R EL-Nahas, Mansoura University
- Investigators
- Yaser Osman, MD, Study chair, ProfessorMahmoud Laymon, MD,MRCS, Study chair, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101563
- Sponsor's protocol ID
- 2371
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helal ME, El-Nahas AR, Laymon M, Elsawy AA, Osman Y. Optimal duration between drainage for obstructing renal or ureteral stones associated with infection and ureteroscopic lithotripsy: a randomized controlled trial. World J Urol. 2026 Mar 10;44(1):227. doi: 10.1007/s00345-025-06124-z.
PubMed 41805964
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration Between Drainage for Obstructing Renal or Ureteral Stones Associated With Infection and Ureteroscopic Lithotripsy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06101563
- Acronym / sponsor ID
- 2371
- Conditions
- Ureter Stone, Renal Stone, Ureteric Obstruction
- Keywords
- Ureteroscopy, Sepsis, infectious complications, ureteric calculi, Renal calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Oct 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.
This study will be conducted to compare early (seven days) versus delayed (14-21 days) definitive ureteroscopic lithotripsy after initial drainage for obstructing ureteral or renal stones associated with infection.
Detailed description
All the study participants will be monitored during the early post-operative period for post-operative pain and complications. The rate and grade of reported complications will be determined according to modified Dindo-Clavian grading system. After ensuring safe status for discharge, all patients will be reassessed at the outpatient department after 4 weeks by NCCT to assess stone free status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early | Active comparator | Procedure: Early ureteroscopyPatients will be managed by ureteroscopic lithotripsy 7 days after drainage. |
| Delayed | Active comparator | Procedure: Delayed UreteroscopyPatients will be managed by ureteroscopic lithotripsy 14-21 days after drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obstructing ureteral or renal stone <20 mm.
- Associated clinical evidence of acute upper urinary tract infection based on systemic inflammatory response syndrome (SIRS).
Key exclusion criteria (3 listed)
- History of endoscopic instrumentation to the urinary tract in the last 4 weeks prior to presentation.
- Bilateral obstructed kidneys necessitating bilateral drainage.
- Associated emphysematous pyelonephritis or perinephric abscess.
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 |
|---|---|---|
| Early ureteroscopyPatients will be managed by ureteroscopic lithotripsy 7 days after drainage. | Procedure or surgery | Early |
| Delayed UreteroscopyPatients will be managed by ureteroscopic lithotripsy 14-21 days after drainage. | Procedure or surgery | Delayed |
Primary outcome
Percentage of postoperative infectious complications in treatment groups
Time frame: 30 days
Difference in post-URS infectious complications between the study groups. infectious complications are defined as presence of urinary tract infection with one of the following findings: - Body temperature more than 38.3C or below 36C. - Tachycardia (>90/minute). - Respiratory rate more than 20/minute. - Disturbed mental status. - Systolic blood pressure < 90 mmHg \& mean arterial pressure < 70 mmHg or systolic blood pressure decrease < 40 mmHg. - WBC >12,000 or <4,000.
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 8 Nov 2024.
- Derived from this study: PubMed 41805964Helal ME, El-Nahas AR, Laymon M, Elsawy AA, Osman Y. Optimal duration between drainage for obstructing renal or ureteral stones associated with infection and ureteroscopic lithotripsy: a randomized controlled trial. World J Urol. 2026 Mar 10;44(1):227. doi: 10.1007/s00345-025-06124-z.
- 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.
Yaser Osman, MD study chair
Professor
Mahmoud Laymon, MD,MRCS study chair
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early ureteroscopy and Delayed Ureteroscopy in people with Ureter Stone and Renal Stone, run by Mansoura 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 2 inclusion and 3 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 8 Nov 2024. 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?
Percentage of postoperative infectious complications in treatment groups (time frame: 30 days). 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 NCT06101563, 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 8 Nov 2024.