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

NCT05952635 | Completed DMC

• 1 other identifier: MRER2023-001
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Stone

Keywords

Kidney stone; Flexible ureteroscopy; Ureteral access sheath

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Stone-free rate at 3 months

  Postoperative 3 month

• 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

Study Arms (2)

Tip bendable suction ureteral access sheath (S-UAS) group

EXPERIMENTAL

Patients will use S-UAS during flexible ureteroscopy.

Procedure: Tip bendable suction ureteral access sheath

Traditional ureteral access sheath group

NO INTERVENTION

Patients will use traditional UAS during flexible ureteroscopy.

Interventions

Tip bendable suction ureteral access sheath PROCEDURE

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.

Tip bendable suction ureteral access sheath (S-UAS) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Urology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

Related Publications (1)

• Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.

  PMID: 39070176 DERIVED

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 19, 2023
• Study Start: August 2, 2023
• Primary Completion: February 28, 2024
• Study Completion: June 21, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)