Ultrasound Guided Ureteroscopy and Ureteric Stones

Ultrasound Guided Ureteroscopy for the Treatment of Lower Third Ureteric Stones in Adults

The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.

Study Overview

• Status: Completed
• Conditions: Ureteric Stone
• Intervention / Treatment: Procedure: ureteroscopy; Radiation: Ultrasonography

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
2. Age group 18 years old or above.
3. Stone size 15 mm or less.

Exclusion Criteria:

1. Patients with bilateral ureteric stones
2. Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
3. Previously failed ureteroscopy or previous ureteroneocystostomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standardized ureteroscopy group	Procedure: ureteroscopy; The patients will be subjected to rigid ureteroscopy
OTHER: Ultrasonography ureteroscopy group	Procedure: ureteroscopy; The patients will be subjected to rigid ureteroscopy; Radiation: Ultrasonography; The patients will be subjected to Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients treated effectively by the two methods	1 hour

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 14, 2018
• First Posted (ACTUAL): January 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: USUUS

Drug and device information, study documents

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