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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | single arm without placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allium ureteral stent | Device | observe the effficacy and safety of long-term self expanding ureteral stents for treating refractory ureteral stricture |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chung Cheng Wang, MD PhD | Contact | 886-26723456 | 6620 | ericwcc@ms27.hinet.net |
| Hsin-Yi Lin, BS | Contact | 886-26723456 | 6621 | hhan309@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chung Cheng Wang, MD PhD | En Chu Kong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| En Chu Kong Hospital | Recruiting | New Taipei City | 23702 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35231922 | Result | 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. | |
| 29595037 | Result | 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. |
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Other researchers can e-mail to us for data sharing
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| ID | Term |
|---|---|
| D006869 | Hydronephrosis |
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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single group without control
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no masking
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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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014515 | Ureteral Diseases |
| D052878 | Urolithiasis |