Laser Lithotripsy for Ureteral Stones

Comparison Between Retrograde and Antegrade Ureteroscopic Laser Lithotripsy for Management of Medium Sized Proximal Ureteral Stones: A Randomized Prospective Study

Objectives: To present the outcomes of retrograde and antegrade ureteroscopic laser lithotripsy in the treatment of proximal ureteral stones ranging in size from 10 to 20 millimeters in diameter.

Patients and methods: From March 2023 to December 2023, 70 patients were included in this prospective randomized double-arm interventional study. Patients were divided into two groups: Group 1: (35 patients) had semi-rigid retrograde ureteroscopic laser lithotripsy and group 2: (35 patients) had semi-rigid antegrade ureteroscopic laser lithotripsy.

Study Overview

• Status: Completed
• Conditions: Ureteric Stone
• Intervention / Treatment: Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy

Detailed Description

The present study was conducted in Al-Azhar University Hospital (Damietta branch), urology department,at the period from March 2023 to December 2023. Seventy patients with symptomatic proximal medium sized ureteric stones were classified in two groups Retrograde Uretroscopic Laser Lithotripsy (group 1) and Antegrade Ureteroscopic Laser Lithotripsy (group 2) .

The preoperative-(patient- and stone-related), intraoperative- and postoperative- related parameters that might influence the perioperative course and short-term clinical outcomes were evaluated.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt, 34517
    • Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Patients with medium-sized proximal ureteral stones (10-20 mm) situated between the ureteropelvic junction and the top edge of the L5 vertebral body; age 18-65 years

Exclusion Criteria:

• Pregnancy, bleeding disorders, morbid obesity (BMI > 35), patients with stenosis of the ureter, history of previous surgery on the ipsilateral ureter, patients with a simultaneous kidney stone requiring surgery, and patients with an active urinary tract infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Retrograde Ureteroscopic Laser Lithotripsy; In this arm we used the retrograde ureteroscopic Laser lithotripsy to clear the uretric stones. After the end of the procedure, all patients were followed for stone free rate as the primary outcome	Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy; Comparison Between Retrograde and Antegrade Ureteroscopic Laser Lithotripsy for Management of Medium Sized Proximal Ureteral Stones: A Randomized Prospective Study
Active Comparator: Antegrade Ureteroscopic Laser Lithotripsy; In this arm we used the antegrade ureteroscopic Laser lithotripsy to clear the uretric stones. After the end of the procedure, all patients were followed for stone free rate as the primary outcome.	Procedure: Retrograde and Antegrade Ureteroscopic Laser Lithotripsy; Comparison Between Retrograde and Antegrade Ureteroscopic Laser Lithotripsy for Management of Medium Sized Proximal Ureteral Stones: A Randomized Prospective Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	number of patients reported complete clearance of stones after intervention	Direct after intervention

Collaborators and Investigators

• Sponsor: Mahmoud Helmy El saeed Hussein

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: laser treatment; ureteroscope; ureteric stones; retrograde; antegrade
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: Urosurg./Ms/2023/0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No