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NCT Number: NCT07177313

Primary Ureteroscopy for Acute Obstructive Nephropathy Due to Ureteral Stones: A Prospective Non-randomized Feasibility and Safety Trial

Ureteroscopy (URS) is a widely used minimally invasive procedure for the management of ureteral and renal stones (1). While the procedure is generally safe and effective, patient factors such as renal function, operative time, and ASA classification may influence outcomes (2).

Ureteral stones were found to be associated with deteriorated kidney function in affected patients (3). In cases of elevated urea and creatinine levels, pre-stenting of ureteroscopy was indicated (4). Limited number of studies have directly assessed the primary ureteroscopy without preoperative stenting outcomes in patients with normal versus deteriorated renal function. Understanding the impact of renal function on URS outcomes can help. A single procedure translates to reduced patient burden through fewer hospital visits, less time spent in the operating room, and a quicker return to daily activities, thus improving comfort and convenience. This approach also yields cost savings by eliminating the expenses associated with a second procedure, including hospital stays, anesthesia, and surgical supplies. Moreover, immediate stone removal via primary URS offers faster symptom relief and avoids potential stent-related complications such as pain, infection, and migration. However, the decision to forego staging must be carefully weighed against individual patient risk factors and stone complexity, as those with severe obstruction, infection, or compromised renal function may still benefit from pre-stenting to optimize procedural safety and outcomes.

This study aims to evaluate whether elevated creatinine levels influence stone-free rates, complication rates, and procedural success in patients undergoing primary URS.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Adults (>18 years) with acute unilateral ureteral obstruction confirmed by:
  • Non-contrast CT (stone size ≥5mm)
  • Hydronephrosis on ultrasound
  • Planned for primary URS (no prior stenting/nephrostomy)
  • Renal function eligibility:
  • Acute deterioration (elevated serum Cr and urea) serum creatinine ≥1.3 mg/dL but less than 5 mg/dL

Exclusion criteria

  • Systemic contraindications to URS:
  • Uncorrected coagulopathy (INR >1.5)
  • Active UTI/sepsis (requiring drainage-first approach)
  • Severe cardiopulmonary compromise (ASA class ≥IV)
  • Patients with hypercalcemia.
  • hyperkalemia >6.5 mEq/L
  • Metabolic acidosis (pH <7.1)
  • Patients with pulmonary edema.
  • Patients with uremic encephalopathy.
  • Bilateral obstruction
  • Known ureteral stricture distal to stone

Treatment and study plan

Ureteroscopy

Procedure

patients presenting with acute ureteral obstruction who undergo primary ureteroscopy (URS).

Primary outcomes

  1. post operative complications

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.