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

NCT06722703 | Not Yet Recruiting DMC

• 1 other identifier: ESWL vs FURS UUS
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stone Ureter

Keywords

upper ureteric stones; ESWL; flexible uretroscopy

Outcome Measures

Primary Outcomes (1)

• The stone-free rate (SFR)

  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

  1 month

Study Arms (2)

ESWL group

EXPERIMENTAL

The surgical technique of shock wave lithotripsy

Procedure: shock wave lithotripsy

FURS group

EXPERIMENTAL

Flexible ureteroscope lithotripsy

Procedure: Flexible ureteroscope lithotripsy

Interventions

shock wave lithotripsy PROCEDURE

Extracorporeal shock wave lithotripsy will be performed using a third-generation electromagnetic lithotripter The focal depth is 110 mm; the focal area is 7 mm (radial) and 45-50 mm (axial), and the focal pressure is 6-30 MPa). The procedure is performed in a supine or prone position without anesthesia. Stone localization and simultaneous real-time monitoring during the process will be performed by ultrasound). The shock frequency is 60-90 (shock waves/min). The total number of shock waves applied for one session is between 1500 and 2500 waves, or the session is stopped at a significant stone fragmentation is detected. The voltage applied per session ranged from 10 to 16 kV with stepwise power ramping strategy. All procedures in the SWL group are outpatient procedures.

ESWL group

Flexible ureteroscope lithotripsy PROCEDURE

All F-URS cases will be performed by a single surgeon (HMI). A guidewire is placed in the upper urinary tract through a rigid cystoscope under fluoroscopic guidance. An 8-10 F dual lumen catheter is used to dilate the intramural ureter and to fix a second guidewire with hydrophilic coat. The 7.5 F flexible ureteroscope is passed into the upper urinary tract in a monorail fashion over the second wire. A holmium-YAG laser is used at an energy setting of 0.8-1 J and a rate of 10-15 Hz. A 200 µm laser fibre is used for delivering laser energy to the stones. A 2.2 F tipless nitinol basket is used to displace the stones from the lower pole to an upper pole calyx before disintegration. Adequate fragmentation is considered when fragments are smaller than the diameter of the guide wire. Stone fragments will be left for spontaneous passage. At the end of the procedure, the whole collecting system will be inspected for residual stones and a double pigtail ureteric stent will be left for 2 weeks t

FURS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 29686172 BACKGROUND

• 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.

  PMID: 38680579 BACKGROUND

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Central Study Contacts

Taha Abdulrahim Bassery Bakhit, resident doctor

CONTACT

+2 01016766014; Bassrytaha123@gmail.com

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: resident doctor at urology department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12