Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy

Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.

Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).

Inclusion criteria

• Patients who are > 18, < 80 years of age; inclusive of males and females.
• Patients with unilateral ureteral or renal stone fragments < 2mm, post-uncomplicated ureteroscopy (UURS).
• Patients with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the Investigator.
• Patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments.

Exclusion criteria

• Patients with a known contraindication for treatment with the Uriprene® Stent.
• Patients with a history of an anatomical abnormality of the urinary tract.
• Patients with a known upper or lower urinary tract infection at the time of stent insertion.
• Patients with known renal insufficiency or chronic impairment.
• Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent.
• Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator.
• Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent).
• Presence of ureteral blockage or stricture
• After failed guide wire placement or failed ureteroscopic access
• Impacted ureteral stones still in place
• Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy
• Patients with a solitary kidney
• Presence of ureteral fistula
• Presence of ureteral tumor
• Presence of extrinsic compression of the ureter
• Urinary tract infection
• Staghorn calculi