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

NCT ID: NCT06862141

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-02-01

Brief Summary

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.

Conditions

Nephrolithiasis; Flexible Ureteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bendable suction ureteral access sheath

this group will undergo flexible ureteroscopy using bendable suction ureteral access sheath

Group Type: EXPERIMENTAL

bendable suction ureteral access sheath

Intervention Type: DEVICE

flexible ureteroscopy will be done using bendable suction ureteral access sheath

conventional ureteral access sheath

this group will undergo flexible ureteroscopy using conventional ureteral access sheath

Group Type: EXPERIMENTAL

conventional suction ureteral access sheath

Intervention Type: DEVICE

flexible ureteroscopy will be done using conventional suction ureteral access sheath

Interventions

bendable suction ureteral access sheath

flexible ureteroscopy will be done using bendable suction ureteral access sheath

Intervention Type: DEVICE

conventional suction ureteral access sheath

flexible ureteroscopy will be done using conventional suction ureteral access sheath

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Abdelazez Anwar Nuser

Teaching assistant of urology , urology department , menoufia university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Menoufia University

Shebin Elkom, Menoufia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Kamal Omar

Role: CONTACT

kimo_81eg@yahoo.com

+201066949454

Facility Contacts

Mohamed Ibrahim Abozaid

Role: primary

Mabuzaid84@yahoo.com

+201068588750

Other Identifiers

FANS protocol

Identifier Type: -

Identifier Source: org_study_id