Randomised Evaluation of Stent Insertion after uncomplicated endourological Stone Treatment (RESIST)
Kidney stones affect more than 1 in 10 people over a lifetime (1). These are often treated with ureteroscopy (URS) and/or ureterorenoscopy (FURS), with or without ureteric stent insertion. The rationale for ureteric stent insertion in this context is generally to avoid perceived risk of postoperative ureteric obstruction due to residual stone fragments, blood clots or oedema (2). However, evidence confirms that such obstruction is rare following uncomplicated ureteroscopy (3,4), and placement of a ureteric stent is often associated with a significant negative impact on a patient’s quality of life, due to stents’ propensity to cause symptoms such as pain, haematuria (blood in the urine) and urinary frequency/urgency. Furthermore, stent placement mandates stent removal at a later date, often requiring a second invasive procedure. The estimated national cost of post-ureteroscopy stent insertion in the UK is £18 million per annum.
Accordingly, UK (NICE) and European (EAU) guidelines recommend against routine stent insertion following uncomplicated URS/FURS (5,6). Pilot work from our group, however, has found that in practice, ureteric stent insertion remains as high as 92% following uncomplicated ureteroscopy (7). This is perceived to reflect a lack of confidence amongst the urology community in the currently available evidence relating to this topic. The majority of urologists surveyed (81% of 300 respondents) stated that they would have equipoise to randomise patients in a trial of stent insertion versus no stent insertion (7). Therefore, there is a pressing need to obtain robust data in a UK setting, that will definitively determine the impact of stent avoidance versus placement in this context and further inform best practice guidelines.
The aim of RESIST is to conduct a multicentre single-blinded randomised controlled trial (RCT) to determine the clinical and cost effectiveness of prophylactic ureteric stent insertion compared to avoidance of ureteric stent insertion in adult patients undergoing definitive unilateral uncomplicated URS/FURS to treat ureteric and/or renal stones.
Evaluating the two patient groups post uncomplicated URS/FURS: a. with ureteric stent insertion and b. without ureteric stent insertion, RESIST aims to answer the following questions:
How is patient quality of life (QoL) influenced by stent insertion compared to no stent insertion following uncomplicated URS/FURS?
Do procedure complication rates, unplanned healthcare visits and pain/analgesic use differ between stented and unstented groups?
What is the cost-effectiveness of routine stent insertion compared to avoidance of stent insertion following uncomplicated URS/FURS?
How do patients perceive routine ureteric stent insertion and the acceptability of placement or avoidance of a prophylactic stent?
RESIST is a pragmatic, single-blinded superiority trial, with an embedded qualitative study and an internal pilot. The study flow chart is depicted below. Adult patients with two functioning kidneys who are planned for URS/FURS for a ureteric or renal stone in an elective or emergency setting will be eligible for initial recruitment and enrolment. Following procedure completion, should the surgeon deem the procedure to have been definitive (stone clearance) and uncomplicated, the patient will be eligible for randomisation to insertion versus no insertion of a ureteric stent. Randomisation will be computer-generated in a 1:1 ratio. Patients will be blinded to the presence or absence of a ureteric stent. Patients’ stone-specific quality of life (measured by the pain domain of the Ureteral Stent Symptom Questionnaire (USSQ)) is the primary outcome. In addition, overall quality of life (EQ-5D-5L), pain scores (Numerical Rating Scale), complications (Clavien Dindo), analgesic use and unplanned healthcare contacts will be evaluated at defined intervals over a 30 day period. In addition, healthcare economic analysis will be performed to determine cost-effectiveness of stent placement versus avoidance. Finally, as an embedded qualitative study of patient experience, semi-structured interviews will be conducted with a purposive sample of enrolled patients to explore views on acceptability.
RESIST Flow Chart
Input & Endorsements
RESIST has been designed in close consultation with our Patient and Public Involvement (PPI) group, with consensus reached on key design components and outcome measures.
RESIST has the potential to benefit patients and the NHS as a whole by informing guidance and decision making in the use of stents in uncomplicated URS/FURS. The British Association of Urological Surgeons (BAUS) has selected this research question as one of national importance and BURST have received endorsement from the national committee of kidney stone surgeons to deliver it.
RESIST has also been recognised by GIRFT (Getting It Right First Time) as an important trial that can inform and improve the delivery pathway for acute urinary tract stone management.
Neisius A, Preminger GM. Stones in 2012: epidemiology, prevention and redefining therapeutic standards. Nat Rev Urol. 2013;10:75–7.
Hughes B, Wiseman OJ, Thompson T, Masood J, Smith RD, McIlhenny C, et al. The dilemma of post-ureteroscopy stenting. BJU Int. 2014 Feb;113(2):184–5.
Pengfei S, Yutao L, Jie Y, Wuran W, Yi D, Hao Z, et al. The results of ureteral stenting after ureteroscopic lithotripsy for ureteral calculi: a systematic review and meta-analysis. J Urol. 2011 Nov;186(5):1904–9.
Ordonez M, Hwang EC, Borofsky M, Bakker CJ, Gandhi S, Dahm P. Ureteral stent versus no ureteral stent for ureteroscopy in the management of renal and ureteral calculi. Cochrane Database Syst Rev [Internet]. 2019;(2). Available from: https://doi.org//10.1002/14651858.CD012703.pub2
NICE guideline [NG118] [Internet]. January 2019. Available from:https://www.nice.org.uk/guidance/ng118.
European Association of Urology. European Association of Urology Guidelines on Urolithiasis, 2018. Available at: http://uroweb.org/guideline/urolithiasis/#3. Accessed August 2021.
Bhatt, NR, MacKenzie, K, Shah, TT, et al. Survey on ureTEric draiNage post uncomplicaTed ureteroscopy (STENT). BJUI Compass. 2020; 00: 1– 11. https://doi.org/10.1002/bco2.48