The Effect of Naftopidil for the Double-J Stent Discomfort

Phase 3

Completed

• Conditions: Disorder of Urinary Stent
• Interventions: Drug: Placebo for Naftopidil; Drug: Naftopidil; Drug: Standard treatment

• Registration Number: NCT01959074
• Lead Sponsor: Seoul National University Hospital

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)

Study Timeline

• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Study Start: 2014-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control groups with only analgesics	Placebo for Naftopidil	Control groups will receive only analgesics
Naftopidil	Standard treatment	This interventional group will receive analgesics and naftopidil 75mg po qd.
Control groups with only analgesics	Standard treatment	Control groups will receive only analgesics
Naftopidil	Naftopidil	This interventional group will receive analgesics and naftopidil 75mg po qd.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
USSQ general health 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)

Trial Locations

Locations (6)

National Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Donguk University Ilsan Hospital; 🇰🇷 Goyang, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Kyunggi, Korea, Republic of

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of