Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allium ureteral stent.
- Who it may be relevant to
- Registry conditions: Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience
Overview
To conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
Detailed description
The aim of the study is to conduct a prospective, multi-center study to observe the long-term efficacy and safety of self expanding ureteral stent for treating participants with refractory ureteral stricture.
About 200 participants with refractory ureteral stricture will be enrolled in four hospitals. After the allium ureteral stents are placed, renal function, renal echo, images and associated complications will be recorded.
Interventions
- Device Allium ureteral stent
observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture
Primary outcome measures
- Renal function test [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months]
Secondary outcome measures (2)
- Complications [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months]
- Renal structure [Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months]
Eligibility criteria
Inclusion criteria
- refractory ureteral stricture after at least two times of ureteral dilation
Exclusion criteria
- poor cardiovascular function for anesthesia unwilling to accept the long-term placement of ureteral stent uncontrolled urinary tract infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- En Chu Kong Hospital — New Taipei City
Publications
- Avitan O, Bahouth Z, Shprits S, Gorenberg M, Halachmi S. Allium Ureteral Stent as a Treatment for Ureteral Stricture: Results and Concerns. Urol Int. 2022;106(5):482-486. doi: 10.1159/000522174. Epub 2022 Mar 1. PMID 35231922
- Sampogna G, Grasso A, Montanari E. Expandable metallic ureteral stent: indications and results. Minerva Urol Nefrol. 2018 Jun;70(3):275-285. doi: 10.23736/S0393-2249.18.03035-7. Epub 2018 Mar 28. PMID 29595037
Identifiers
NCT: NCT05455307 · eck20200608