STent EvaluatioN Trial (STENT) - A Multicentre Double Blinded Randomized Controlled Trial Comparing the Bard Inlay Optima Stent with the Cook Universa Soft Ureteral Stents Using The Validated Ureteric Stent Symptom Questionnaire

This study is comparing the Bard Inlay Optima and Cook Universa Soft Ureteral Stents when used for stent insertion for upper urinary tract calculi or large stones before lithotripsy or after ureteroscopy at the Townsville and Toowomba Hospital. Materials: The materials being used will be first and foremost the two aforementioned stents – the Bard Inlay Optima and Cook Universa Soft Ureteral Stents. Both will be inserted as part of the clinical trial by urological registrars or consultant surgeons at the Townsville and Toowomba Hospital. Their post operative stent symptoms will be measured through two methods. First, the Ureteral Stent Symptoms Questionnaire (USSQ) – a validated questionnaire produced by the Bristol Urological Institute to measure post-operative stent related symptoms. ] Procedures: Following patient consenting for the procedure, patient’s will have the stent they are randomized to (either Bard Inlay Optima or Cook Universa Soft), inserted by the urologist registrar or consultant as stated above. Intra-operatively, multi-length double J stents of either the Bard Inlay Optima (4.7 French) and Cook Universa Soft (5 french) variety will be inserted. Post operatively, patients will be provided with appropriate medications for stent pain if desired. Patients will be then receive a phone call from the Principal Investigator (PI) at 1 and 3 weeks after insertion and surveyed as per the USSQ. We would note that throughout this the PI conducting the survey will be blinded to which stent was inserted in the patient. All data will be recorded in a relevant data collection tool in which data pertaining to the date of procedure, patient characteristics, USSQ score and post operative opiod use for SRS. Early stent removal will be defined as having the stent removed prior to 3 weeks. Who: The intervention will be delivered by a recognized urology registrar or consultant urologist at the Townsville or Toowoomba Hospital. The survey will be conducted by the Principal Investigator, a doctor with experience in urology. Mode of Delivery: The surveys above will be delivered via telephone surveys delivered individually to each patient with the stent inserted. Number of times: The intervention (the stenting) will only be delivered once however patients will be followed up at two points – 1 week and 3 weeks post operatively. Location: The intervention will occur at the Townsville, Toowoomba and Redcliffe Hospital Intervention Adherence or Fidelity: Patients will be followed up if they have early stent removal and this will be documented accordingly in the data collection tool. A data monitoring board will be set up for the study to ensure randomization and protocol is being carried out as appropriate.