OPTIMAL STENTS DURING RENAL COLIC
COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2018
CompletedFirst Submitted
Initial submission to the registry
June 23, 2019
CompletedFirst Posted
Study publicly available on registry
June 27, 2019
CompletedOctober 13, 2022
October 1, 2022
4 months
June 23, 2019
October 11, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
body pain
At each follow-up appointment, patients completed a survey in which the visual analog scale pain (VASP) was filled
4 weeks
bladder overactivity
At each follow-up appointment, patients completed a survey in which the "bladder awareness tool" (VASP) was filled
4 weeks
Study Arms (2)
group A
OTHERpatients who received polyurethane stents
group B
EXPERIMENTALpatients who received silicone stents
Interventions
patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group
Eligibility Criteria
You may qualify if:
- confirmed ureteral stone
- prescribed ureteral stent placement for pain syndrome relief
You may not qualify if:
- an active urinary tract infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Pavlov Saint Petersburg University
Saint Petersburg, 197342, Russia
Related Publications (1)
Gadzhiev N, Gorelov D, Malkhasyan V, Akopyan G, Harchelava R, Mazurenko D, Kosmala C, Okhunov Z, Petrov S. Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study. BMC Urol. 2020 Feb 3;20(1):10. doi: 10.1186/s12894-020-0577-y.
PMID: 32013936DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of endourology
Study Record Dates
First Submitted
June 23, 2019
First Posted
June 27, 2019
Study Start
June 1, 2018
Primary Completion
October 10, 2018
Study Completion
October 10, 2018
Last Updated
October 13, 2022
Record last verified: 2022-10