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Role of Pre-stenting Before Retrograde Intrarenal Surgery With Miniaturized Flexible Ureteroscopes

NCT07773090 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-08-21

No results posted yet for this study

Summary

This prospective randomized controlled trial will compare retrograde intrarenal surgery performed after routine preoperative ureteral stenting with direct retrograde intrarenal surgery without planned preoperative stenting in adults with unilateral renal calculi measuring 10-20 mm. The study will evaluate stone-free rate, ureteral access, need for rescue stenting, operative outcomes, complications, staged procedures, postoperative recovery, and auxiliary treatment.

Conditions

  • Renal Calculi

Interventions

PROCEDURE

Preoperative double-J ureteral stenting followed by retrograde intrarenal surgery

Participants randomized to this group will undergo insertion of a 4.8-6 French double-J ureteral stent approximately 7-14 days before definitive RIRS. The stent will be used to provide passive ureteral dilation. Definitive RIRS will then be performed using a miniaturized digital flexible ureteroscope and holmium:YAG laser lithotripsy. The stent size, length, date of insertion, dwell time, technical success, complications, urinary tract infection, and stent-related symptoms will be recorded.

PROCEDURE

Direct retrograde intrarenal surgery without planned preoperative ureteral stenting

Participants randomized to this group will undergo direct RIRS without planned preoperative ureteral stenting. No routine active ureteral dilation will be performed before initial access. Gentle dilation may be performed when clinically necessary and will be documented. If safe access cannot be achieved, the procedure will be discontinued and a double-J ureteral stent will be inserted for passive dilation. Repeat RIRS will be scheduled approximately 7-14 days later.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Abul-fotouh Ahmed, MD · Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-19
Primary Completion
2028-08-14
Completion
2028-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773090 on ClinicalTrials.gov