Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

Study Overview
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Brief Summary
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Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Detailed Description
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Ureteral stents have been widely used in many urological operations. The main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Thus, The investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. Now this product has been approved by European Medical Device Administration. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

Official Title
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Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

Conditions
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Ureter Stricture, Hydronephrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who used  Bioteq Ureteral Stent Set (Long-Term Type) in their treatments. Patients with complete basic parameters. Exclusion Criteria: Patients with any of the following conditions are excluded from this clinical study: Patients with incomplete basic parameters. The minorities, children and special populations

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long-term type ureteral stent set<br>Patients with Long-term type ureteral stent set due to ureteral stricture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydronephrosis | no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis | 5 years | 
| Renal function | serum BUN level | 5 years | 
| Renal function | serum Creatine level | 5 years | 
| Days of stent placement | Mean days of stent placement | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureter Stricture, Hydronephrosis