Clinical trial NCT06722703: ESWL Vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study
Official title: ESWL Vs Flexible Uretroscopy in Management of Upper Ureteric Stones a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stone Ureter
Keywords: upper ureteric stones
ESWL
flexible uretroscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The stone-free rate (SFR)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yuri P, Hariwibowo R, Soeroharjo I, Danarto R, Hendri AZ, Brodjonegoro SR, Rasyid N, Birowo P, Widyahening IS. Meta-analysis of Optimal Management of Lower Pole Stone of 10 - 20 mm: Flexible Ureteroscopy (FURS) versus Extracorporeal Shock Wave Lithotripsy (ESWL) versus Percutaneus Nephrolithotomy (PCNL). Acta Med Indones. 2018 Jan;50(1):18-25.
citation: Jahrreiss V, Seitz C, Quhal F. Medical management of urolithiasis: Great efforts and limited progress. Asian J Urol. 2024 Apr;11(2):149-155. doi: 10.1016/j.ajur.2023.05.001. Epub 2023 Jun 29.