Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery

Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery (RIRS): Study Protocol of a Multicentre, Prospective, Single-blinded, Randomized Controlled Trial

Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world[1,2]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications.

The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend >90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.

Study Overview

• Status: Completed
• Conditions: Kidney Stone
• Intervention / Treatment: Procedure: Tip bendable suction ureteral access sheath

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510230
      • Department of Urology, The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged ≥ 18 years;
• American Society of Anesthesiology score 1-3;
• Upper urinary stone (kidney stone or upper ureteral stone) diameter of ≤ 3 cm confirmed by CT;
• Capable of giving written informed consent, which includes adherence with the requirements of the trial.

Exclusion Criteria:

• Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit);
• Patients with uncontrolled UTI;
• Patients with health or other factors that are absolute contraindications to RIRS;
• Patients unable to understand or complete trial documentation.

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: Tip bendable suction ureteral access sheath (S-UAS) group; Patients will use S-UAS during flexible ureteroscopy.	Procedure: Tip bendable suction ureteral access sheath; Patient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications.
No Intervention: Traditional ureteral access sheath group; Patients will use traditional UAS during flexible ureteroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate stone-free rate	No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free.	Postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay		From date of operation until the date of discharge, assessed up to 2 weeks.
Further interventions received up to 3 months post randomization		Postoperative 3 month
Complications up to 3 months post randomization		Postoperative 3 month
Change of Quality of life Score (prior to surgery and at month 3 after randomization)		Postoperative 3 month
Operative time	The duration from the insertion of the endoscope into the urethra to the completion of stent placement.	From start of operation until the end of operation, assessed up to 2 weeks.
Stone-free rate at 3 months	No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free.	Postoperative 3 month

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborators: Xiangya Hospital of Central South University; University of Malaya; Guizhou Provincial People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Jose R. Reyes Memorial Medical Center; Prof. Dr. Ilhan Varank Education and Training Hospital; Xinchang County Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 22, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Flexible ureteroscopy; Ureteral access sheath; Kidney stone
• 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: MRER2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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