Skip to main content
OpenTrials
Completed

NCT Number: NCT05952635

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510230, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Immediate stone-free rate

    Time frame: Postoperative day 1

    No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free.

Secondary outcomes

  1. Stone-free rate at 3 months

    Time frame: Postoperative 3 month

    No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free.

  2. Duration of hospital stay

    Time frame: From date of operation until the date of discharge, assessed up to 2 weeks.

  3. Further interventions received up to 3 months post randomization

    Time frame: Postoperative 3 month

  4. Complications up to 3 months post randomization

    Time frame: Postoperative 3 month

  5. Change of Quality of life Score (prior to surgery and at month 3 after randomization)

    Time frame: Postoperative 3 month

  6. Operative time

    Time frame: From start of operation until the end of operation, assessed up to 2 weeks.

    The duration from the insertion of the endoscope into the urethra to the completion of stent placement.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2023
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.