Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy

Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial

Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers. According to the guidelines of American Urologic Association (AUA) and European Association of Urology (EAU), patients with a burden of less than 20 mm in kidney calculi can choose RIRS as the frst-line surgical treatment with good stone-free rate (SFR). (2, 3) The application of RIRS for urinary stones has increased signifcantly, and the indications have expanded due to developments in minimally invasive technology and equipment. (4) With the development of stone retrieval devices and miniaturized fexible ureteroscopes, RIRS is more widely used for treating renal calculi, even for high burden stones. (5, 6) The application of ureteral access sheath (UAS) in RIRS can improve surgical vision, reduce intrarenal pressure (IRP), and decrease postoperative infectious complications. (7-9) Several reports have demonstrated the superiority of suctioning UAS, including shorter operation time, higher SFR and lower incidence of infectious complications compared with traditional ureteral access sheath, but none of these suctioning UAS can reach the renal calyces. (10-12)

A novel tip-flexible suctioning ureteral access sheath with flexible terminal was designed, which delivered the tip of the ureteral access sheath to renal calyces. However, data comparing novel tip-flexible suctioning ureteral access and traditional ureteral access sheath is lacking in RIRS.

Therefore, we designed a prospective controlled analysis to compare the efficacy and safety of novel tip-flexible suctioning ureteral access sheath and traditional ureteral access sheath combined with flexible ureteroscope (FURS) in treating renal calculi.

Study Overview

• Status: Recruiting
• Conditions: Nephrolithiasis; Flexible Ureteroscopy
• Intervention / Treatment: Device: bendable suction ureteral access sheath; Device: conventional suction ureteral access sheath

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Kamal Omar; Phone Number: +201066949454; Email: kimo_81eg@yahoo.com

Study Locations

• Egypt
  • Menoufia
    • Shebin Elkom, Menoufia, Egypt, 35111
      • Recruiting
      • Faculty of Medicine, Menoufia University
      • Contact: Mohamed Ibrahim Abozaid; Phone Number: +201068588750; Email: Mabuzaid84@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis: Radiologically confirmed renal stones (e.g., CT, ultrasound, or X-ray).
• Stone size within a specific range (e.g., 5-20 mm).
• Indication for Treatment: patients indicated for flexible ureteroscopy due to renal stones.
• Anatomical Suitability: normal or mildly altered renal anatomy that allows safe use of the access sheath.
• Willingness to participate and provide written informed consent.

Exclusion Criteria:

• - Medical Conditions: Active urinary tract infection (UTI) or sepsis. Coagulopathy or inability to discontinue anticoagulation therapy. Significant comorbidities (e.g., severe cardiopulmonary disease). Pregnancy: Pregnant or breastfeeding individuals.
• Anatomical or Surgical Factors:

Severe ureteral stricture or obstruction preventing sheath placement. Congenital abnormalities affecting the urinary tract. - Stone Factors: Stones larger than the sheath's operational limit (e.g., >20 mm). Multiple stones in different calyces that cannot be accessed in one session.

- Previous Treatment: Recent (<6 weeks) or repeated interventions for the same stones (e.g., prior lithotripsy or ureteroscopy).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bendable suction ureteral access sheath; this group will undergo flexible ureteroscopy using bendable suction ureteral access sheath	Device: bendable suction ureteral access sheath; flexible ureteroscopy will be done using bendable suction ureteral access sheath
Experimental: conventional ureteral access sheath; this group will undergo flexible ureteroscopy using conventional ureteral access sheath	Device: conventional suction ureteral access sheath; flexible ureteroscopy will be done using conventional suction ureteral access sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate stone free rate	measured by the number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.	one day postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 month stone free rate	measured by number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.	3 months postoperatively
duration of hospital stay	measured by number of days from the day of operation till the discharge day	2 weeks
secondary intervention	measured by the number of interventions received post randomization	3 months
complications	measured by the number of complications experienced by the patients	3 months
costs	measured by the total costs of patient during hospitalization and up to 3 months	3 months postoperatively

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes