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Not yet recruitingNCT06592469Updated Sep 19, 2024

Outcome of URS in Fresh Versus Recurrent Cases of Stone Ureter

An observational study in Stone Ureter, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Sex
All
01

Study summary

Comparison of Ureteroscopy in fresh versus recurrent cases of stone ureter

Read the detailed description

Urolithiasis is a common cause of both urology outpatient clinic and emergency room encounters. Approximately 75-90% of ureteral stones pass spontaneously. from this point of view other managements of ureteric stones either ESWL, ureteroscopy or open surgery according to location, site, size, and density. Ureteroscopy is commonly used to diagnose and treat kidney and ureteral stones, ureteral strictures, and urothelial cancers. Semirigid URS is the gold standard of treatment for ureteral stones. High success rates and low morbidity have been reported in semirigid URS. but complications still occur in some cases. The possibility to predict their occurrence should influence patient advisement and better case selection. there are many predictors of successful URS as age, gender, previous ESWL, and stone character. In addition, the impacted stone is a risk factor, and it is described in the literature as ureteral wall thickness, higher grades of hydronephrosis, ureteral stricture, polyp, inflammatory reaction, and difficulty to introduce the guide wire. the literature is very poor in illustrating the previous procedures as a predictor of successful URS only seen in very few original articles as second-time URS after any procedure decreases the rate of success, so it is a point of research that Amr Moustafa aims to clarify. Amr Moustafa will conduct a prospective study to evaluate the outcomes of URS for stones in the fresh and recurrent cases.

02

Conditions studied

  • Stone Ureter

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Keywords

  • URS
03

In context

Ureterolithiasis

84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.

This study's planned enrollment of 80 is below the median of 136 across 13 observational studies indexed under Ureterolithiasis.

Browse Ureterolithiasis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

.4. 2- Study subjects:

  1. Inclusion criteria:

    • all cases with middle and lower ureteric stone candidate for endoscopy.
    • Stone 15mm or less.
  2. Exclusion criteria:

    • Patients with a ureteral stent.
    • Patient refusing participation.
    • Pregnant woman.
    • Active urinary tract infection.
    • Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.
  3. Sample Size Calculation:

Based on previously reported frequency of primary failure of ureteocopy in case of recurrent stone that ranged between 1-37% (*reference)* a total sample size of 62 patients will be required ( 31 patients in each arm) with the following assumption; alpha error 5%, 80% power with 95% confidence interval

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • all cases with middle and lower ureteric stone candidate for endoscopy.

      • Stone 15mm or less.

Exclusion criteria

Exclusion Criteria:

    • Patients with a ureteral stent.

      • Patient refusing participation.
      • Pregnant woman.
      • Active urinary tract infection.
      • Comorbidities prevent intervention including bleeding tendency or uncorrectable coagulation profile.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fresh cases

    Outcome of URS in fresh stone ureter

    Procedure: Ureteroscopy

  • Recurrent cases

    Outcome of URS in recurrent cases of stone ureter post ESWL ,URS , open surgery

    Procedure: Ureteroscopy

Interventions

  • ProcedureUreteroscopy

    URS is done to each group to reveal outcome of stone free rate in fresh versus recurrent cases of stone ureter

    Also known as: URS

06

What researchers measure

Primary outcomes

  1. Stone free rate of Urereroscopy in fresh versus recurrent cases of stone ureter

    • Stone free rate with a mean operative time of 1 hr by MSCTKUB or Plain KUB to determine residual stones post operative

    Time frame: 1 day post operative by MSCTKUB or Plain KUB to determine residual stones post operative

Secondary outcomes

  1. • Rate of intraoperative findings in each group.

    • Rate intraoperative findings in each group by ureteroscope

    Time frame: Intraoperative

  2. • The rate of complication in each group

    To determine rate of intraoperative complications as bleeding , ureteric perforation , residual stones

    Time frame: Intraoperative by ureteroscope and one day post operative by MSCT

  3. • The rate of stone impaction in each group

    Rate of stone impaction in each group fresh and recurrent cases

    Time frame: Intraoperative by ureteroscope

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Study locations

1 site
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06592469
Lead sponsor
Assiut University
Responsible party
Amr Moustafa Hussein Soliman (Resident doctor, Assiut University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Amr Moustafa Hussein Soliman, Resident dr
Contact
amr.mustafa303@gmail.com
+201140340697
Fathy Gaber Mahmoud Alanany, Prof of URO
study director · Assiut University
Mahmoud M. Shalaby, Prof of URO
study director · Assiut University
Nasreldin Abdeal Mohammed, Ass Prof
study director · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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