Clinical trial NCT01959074: The Effect of Naftopidil for the Double-J Stent Discomfort
Official title: The Effect of Naftopidil for the Double-J Stent Discomfort: Multicenter, Randomized, Double-blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disorder of Urinary Stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dong-A ST Co., Ltd.
First posted: 2013-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
measure: USSQ body pain score
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Secondary outcomes:
measure: USSQ general health score
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
measure: USSQ work performance score
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
measure: USSQ sexual matters score
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
measure: International Prostate Symptom Score(IPSS), QoL score
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
measure: Total analgesics use
timeFrame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyunggi
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Goyang
country: Korea, Republic of
facility: Donguk University Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: