Efficacy and Safety of Allium Ureteral Stent for Treating Refractory Ureteral Stricture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Self-expanding Ureteral Stent for Treating Refractory Ureteral Stricture: Results of a Multicenter Experience

Conditions
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Ureteral Stenosis, Hydronephrosis, Ureteral Stent Occlusion

Intervention / Treatment
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* Device: Allium ureteral stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single group without control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>single arm without placebo control | Device: Allium ureteral stent<br>* observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function test | serum creatinine (mg/dL) | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | device associated complications (e.g. urinary tract infection, stone formation, hematuria, stent migration) | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months | 
| Renal structure | Renal echo (e.g. no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, orsevere hydronephrosis) | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral stone, ureteral stricture, hydronephrosis