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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Kidney Stone

Intervention / Treatment
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* Procedure: Tip bendable suction ureteral access sheath


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tip bendable suction ureteral access sheath (S-UAS) group<br>Patients will use S-UAS during flexible ureteroscopy. | Procedure: Tip bendable suction ureteral access sheath<br>* 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.<br>|
| No Intervention: Traditional ureteral access sheath group<br>Patients will use traditional UAS during flexible ureteroscopy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate stone-free rate | No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free. | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient costs during hospitalization and up to 3 months |  | Postoperative 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney stone, Flexible ureteroscopy, Ureteral access sheath