The Effect of Naftopidil for the Double-J Stent Discomfort

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

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

Study Overview

• Status: Completed
• Conditions: Disorder of Urinary Stent
• Intervention / Treatment: Drug: Naftopidil; Drug: Standard treatment; Drug: Placebo for Naftopidil

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Goyang, Korea, Republic of
    • Donguk University Ilsan Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • National Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Hospital
  • Kyunggi
    • Seongnam, Kyunggi, Korea, Republic of, 463-712
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Naftopidil; This interventional group will receive analgesics and naftopidil 75mg po qd.	Drug: Naftopidil; Naftopidil 75mg 1T qd hs; Other Names: Flivas(TM) in South Korea; Drug: Standard treatment; aceclofenac 100mg on demand; Other Names: Aceclofenac
PLACEBO_COMPARATOR: Control groups with only analgesics; Control groups will receive only analgesics	Drug: Standard treatment; aceclofenac 100mg on demand; Other Names: Aceclofenac; Drug: Placebo for Naftopidil; Placebo 1T qd hs

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (ESTIMATE): October 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Adrenergic alpha-Antagonists; Naftopidil; Aceclofenac
• Other Study ID Numbers: SNUH-URO-2012-04; SNUH-URO-2012-04-DJ (OTHER: SNU Hosptial IRB)