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| ID | Type | Description | Link |
|---|---|---|---|
| SNUH-URO-2012-04-DJ | Other Identifier | SNU Hosptial IRB |
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| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
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This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.
Enrollment
Randomization
Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftopidil | Active Comparator | This interventional group will receive analgesics and naftopidil 75mg po qd. |
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| Control groups with only analgesics | Placebo Comparator | Control groups will receive only analgesics |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftopidil | Drug | Naftopidil 75mg 1T qd hs |
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| Measure | Description | Time Frame |
|---|---|---|
| Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score | DJ stent removal should be done between study day 5 and 15. | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
| USSQ body pain score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
| Measure | Description | Time Frame |
|---|---|---|
| USSQ general health score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) | |
| USSQ work performance score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
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Inclusion Criteria:Patients to be undergone double-J stent indwelling
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang Wook Jeong, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Kyunggi | 463-712 | South Korea | ||
| Kangwon National University Hospital |
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| ID | Term |
|---|---|
| C064357 | naftopidil |
| C056498 | aceclofenac |
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| Placebo for Naftopidil | Drug | Placebo 1T qd hs |
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| Standard treatment | Drug | aceclofenac 100mg on demand |
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| USSQ sexual matters score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
| International Prostate Symptom Score(IPSS), QoL score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
| Total analgesics use | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
| Chuncheon |
| South Korea |
| Donguk University Ilsan Hospital | Goyang | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| National Medical Center | Seoul | South Korea |
| Seoul National University Boramae Hospital | Seoul | South Korea |