Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones

Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.

The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).

Study Overview

• Status: Completed
• Conditions: Flexible Ureteroscopy; Ureteral Access Sheath; Large Renal Stones
• Intervention / Treatment: Procedure: Flexible ureteroscope with ureteral access sheath; Procedure: Flexible ureteroscope without ureteral access sheath

Detailed Description

Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.

Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.

FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.

The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.

Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Valley, Egypt, 72511
    • New Valley University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age > 18 years old.
• Both sexes.
• Patients with upper ureter and renal stones scheduled for flexible ureteroscope.

Exclusion Criteria:

• Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
• Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
• Known ureteric strictures.
• Concomitant ureteric stones.
• Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flexible ureteroscope with ureteral access sheath; Stones will be treated by flexible ureteroscope with ureteral access sheath	Procedure: Flexible ureteroscope with ureteral access sheath; The flexible ureteroscope either directly or via an access sheath, depending on the size of the ureter, a 9.5/11.5 Fr or a 12 Fr access sheath will be used.
Active Comparator: Flexible ureteroscope without ureteral access sheath; Stones will be treated by flexible ureteroscope without ureteral access sheath	Procedure: Flexible ureteroscope without ureteral access sheath; Ureteroscopy will be carried out without a ureteral access sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Time from sterilization till the end of surgery	Intraperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone-free rate	Stone-free status was defined as no residual stones or residual stones with a maximum diameter ≤ 4 mm with no clinical symptoms at 1 month after the procedure	28 days after intervention
Complications	Complications such as mucosal lacerations, bleeding, urosepsis, and stein Strasse.	28 days after intervention
Duration of stay	Time from admission till hospital discharge	28 days after intervention
Number of patients who need ancillary procedures	Need for Ancillary Procedures if there was residual.	28 days after intervention

Collaborators and Investigators

• Sponsor: New Valley University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): March 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: 0739-20233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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