ESWL Vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study

Not Applicable

Not yet recruiting

• Conditions: Stone Ureter

• Registration Number: NCT06722703
• Lead Sponsor: Assiut University

Brief Summary

This comparison between ESWL and flexible ureteroscopy aims to explore the efficacy, safety, and outcomes of these treatments for upper ureteric stones under 15 mm, focusing on stone-free rates, procedural risks, recovery times, and recurrence rates. A thorough understanding of these techniques is essential for optimizing patient outcomes and personalizing treatment strategies.

study aim to evaluate the effectiveness, safety, and cost of SWL compared to flexible uretroscopy in management patients with upper ureteric stone less than 15 mm in size

Detailed Description

The management of upper ureteric stones, particularly those less than 15 mm in size, has seen significant advancements with the development of minimally invasive techniques. Urolithiasis is a common condition, and selecting the most appropriate treatment is crucial for effective stone clearance and minimizing complications. Two widely used approaches in treating upper ureteric stones are Extracorporeal Shock Wave Lithotripsy (ESWL) and Flexible Ureteroscopy (FURS).

ESWL, a non-invasive procedure, uses focused shock waves to fragment the stone into smaller pieces that can be passed naturally through the urinary tract. Its non-invasiveness makes it an attractive option for many patients; however, its success is influenced by factors such as stone composition, location, and patient anatomy. In contrast, Flexible Ureteroscopy (FURS) is a minimally invasive endoscopic technique where a flexible ureteroscope is passed through the urinary tract to directly visualize and fragment the stone using a laser (usually a Holmium: YAG laser). This method allows for a more targeted approach and is often used when ESWL is less effective or contraindicated.

ESWL and FURS have distinct advantages and limitations, and the choice between them depends on factors including stone size, density, location, and patient-specific considerations such as body habitus and anatomical variations.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• patients age>18 years old. Stone site: upper ureteric stone. Stone side: unilateral stones Stone size: stones diameter up to 1cm Stone number: single or multiple Radio-opaque stone

Exclusion Criteria

• patients with solitary kidney or only function kidney renal impairment present of distal obstruction pregnancy, current breast feeding. Bleeding tendency or anticoagulation. ipsilateral ureterolithiasis, Acute or chronic nephritis, or Renal tuberculosis aneurysm of the aorta or renal artery. inability to position the patient on the SWL table (eg, due to severe skeletal deformity or morbid obesity).

radiolucent stones that are not visible on ultrasound. severe metabolic disturbances (eg, cystinuria, primary hyperparathyroidism, or renal tubular acidosis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The stone-free rate (SFR)	1 month	The stone-free rate (SFR) is defined as no evidence of clinically significant stone fragments (≥ 4 mm in size) in combination with a plain X-ray of the urinary tract (KUB) and urinary ultrasound one month after SWL or F-URS