NCT04000178

OPTIMAL STENTS DURING RENAL COLIC

Completed NA Last updated 13 October 2022

What this trial tests

NA trial testing polyurethane stent in Ureteral Stent Occlusion in 50 participants. Completed in 10 October 2018.

Timeline

1 June 2018

Primary endpoint
10 October 2018

10 October 2018

Quick facts

Lead sponsor	St. Petersburg State Pavlov Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2018
Primary completion	10 October 2018
Estimated completion	10 October 2018
Sites	1 location across Russia

Drugs / interventions tested

• polyurethane stent
• silicone stent

Conditions studied

• Ureteral Stent Occlusion — all drugs for Ureteral Stent Occlusion →

Sponsor

St. Petersburg State Pavlov Medical University

Who can join

Adults 18 to 60, any sex, with Ureteral Stent Occlusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study.
   Gadzhiev N, Gorelov D, Malkhasyan V, Akopyan G, et al · · 2020 · cited 26× · PMID 32013936 · DOI 10.1186/s12894-020-0577-y