Flexible Ureteroscopy With Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3cm Renal Stones

Summary

Background: Percutaneous nephrolithotomy (PCNL) is the first-line treatment for renal stones larger than 2 cm according to EAU and AUA guidelines. Advances in flexible ureteroscopy, including smaller disposable ureteroscopes and suction techniques, have expanded its indications. The tip-bendable suction ureteral access sheath (S-UAS) offers improved flexibility and stone-free rates (SFR). This study compares clinical outcomes of flexible ureteroscopy (f-URS) with S-UAS and mini-PCNL in treating 2-3 cm renal stones.

Objective: This study aims to determine if f-URS with S-UAS is non-inferior to mini-PCNL regarding stone-free rates. Secondary objectives include comparing complication rates, surgical time, and hospitalization duration.

Methods: This multicenter, international, prospective, non-inferiority, randomized controlled trial will enroll 720 patients across 12 urological centers. Patients will be randomized to either f-URS with S-UAS or mini-PCNL. Outcomes include immediate and 3-month SFR, operative time, hospital stay, further interventions, complications, and quality of life.

Results: Data will be analyzed using intention-to-treat and per-protocol approaches, with statistical analyses performed using SPSS software.

Conclusion: This study will provide high-level evidence on the effectiveness of f-URS with S-UAS compared to mini-PCNL for medium-sized renal stones.

Conditions

• Urolithiasis
• Kidney Stone

Interventions

PROCEDURE

f-URS

f-URS with S-UAS

PROCEDURE

mini-PCNL

mini-PCNL

Sponsors & Collaborators

• University of Malaya

  collaborator OTHER

• Ankara University

  collaborator OTHER

• Saint Petersburg State University Hospital

  collaborator UNKNOWN

• Fortune Urology Clinic

  collaborator UNKNOWN

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Baoshan No.2 People's Hospital

  collaborator UNKNOWN

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-21

Primary Completion

2025-02-20

Completion

2025-06-04

Countries

• China

Study Locations