Disorder of Urinary Stent
Conditions
Brief summary
This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.
Detailed description
1. Enrollment 1. patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days 2. patients aged more than 20 years 2. Randomization 1. naftopidil 75 mg qd or placebo until Double-J stent removal 2. Standard treatment with pain-killers on demand were also applied.(aceclofenac) 3. Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)
Interventions
DRUGNaftopidil
Naftopidil 75mg 1T qd hs
Placebo 1T qd hs
DRUGStandard treatment
aceclofenac 100mg on demand
Sponsors
Dong-A ST Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) | DJ stent removal should be done between study day 5 and 15. |
| USSQ body pain score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| USSQ work performance 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) |
| International Prostate Symptom Score(IPSS), QoL 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) |
| USSQ general health score | at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days) |
Countries
South Korea
Outcome results
None listed