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

NCT07177313 | Not Yet Recruiting DMC

• 1 other identifier: Acute Obstructive Nephropathy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Obstructive Nephropathy

Outcome Measures

Primary Outcomes (1)

• post operative complications

  3 month

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients presenting with acute obstructive uropathy and uremic renal impairment (defined as serum creatinine ≥1.3 mg/dL)

Procedure: Ureteroscopy

Group2

ACTIVE COMPARATOR

Patients with normal renal function (eGFR ≥60 mL/min/1.73m²) undergoing primary URS for ureteral stones.

Procedure: Ureteroscopy

Interventions

Ureteroscopy PROCEDURE

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

Group 1; Group2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Ureteroscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09