The Effect of Naftopidil for the Double-J Stent Discomfort

Study Overview
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Brief Summary
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This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.

Detailed Description
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Enrollment patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days patients aged more than 20 years Randomization naftopidil 75 mg qd or placebo until Double-J stent removal Standard treatment with pain-killers on demand were also applied.(aceclofenac) Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)

Official Title
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The Effect of Naftopidil for the Double-J Stent Discomfort: Multicenter, Randomized, Double-blind, Placebo Controlled Study

Conditions
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Disorder of Urinary Stent

Intervention / Treatment
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* Drug: Naftopidil
* Drug: Placebo for Naftopidil
* Drug: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients to be undergone double-J stent indwelling >= 20 years undergoing unilateral retrograde double J (DJ) stent placement planned for 5-15 days indwelling Exclusion Criteria: after percutaneous nephrolithotomy, open or laparoscopic ureterolithotomy presence of ureteral stone renal insufficiency (serum Cr > 1.4) febrile urinary tract infection (fever > 38.0°C, evidence of urinary infection ) pregnancy or breast feeding solitary kidney hypersensitivity to Naftopidil current use of any alpha blocker, calcium channel blocker, corticosteroid moderate or sever cardiovascular or cerebrovascular disease hepatic dysfunction prior history of pelvic surgery or irradiation prior history of transurethral resection of bladder tumor or prostate surgery significant active medical illness which in the opinion of the investigator would preclude protocol treatment genetic disorder such ad galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naftopidil<br>This interventional group will receive analgesics and naftopidil 75mg po qd. | Drug: Naftopidil<br>* Naftopidil 75mg 1T qd hs<br>* Other names: Flivas(TM) in South Korea;Drug: Standard treatment<br>* aceclofenac 100mg on demand<br>* Other names: Aceclofenac;|
| Placebo Comparator: Control groups with only analgesics<br>Control groups will receive only analgesics | Drug: Placebo for Naftopidil<br>* Placebo 1T qd hs<br>Drug: Standard treatment<br>* aceclofenac 100mg on demand<br>* Other names: Aceclofenac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |