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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07177313
Enrollment
60
Registered
2025-09-16
Start date
2025-10-01
Completion date
2026-12-01
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Obstructive Nephropathy

Brief summary

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.

Interventions

PROCEDUREUreteroscopy

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
post operative complications3 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026