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

Not Applicable

Recruiting

• Conditions: Nephrolithiasis; Flexible Ureteroscopy

• Registration Number: NCT06862141
• Lead Sponsor: Menoufia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-02
• Study First Submitted: 2025-03-01
• Study First Submitted QC: 2025-03-01
• Study First Posted: 2025-03-06
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immediate stone free rate	one day postoperative	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.

Secondary Outcome Measures

Name	Time	Method
3 month stone free rate	3 months postoperatively	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.
duration of hospital stay	2 weeks	measured by number of days from the day of operation till the discharge day
secondary intervention	3 months	measured by the number of interventions received post randomization
complications	3 months	measured by the number of complications experienced by the patients
costs	3 months postoperatively	measured by the total costs of patient during hospitalization and up to 3 months

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia University; 🇪🇬 Shebin Elkom, Menoufia, Egypt