The Effect of Naftopidil for the Double-J Stent Discomfort

Disorder of Urinary Stent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959074
• Other study ID #: SNUH-URO-2012-04
• Secondary ID: SNUH-URO-2012-04
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2013
• Last updated: December 8, 2015
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Urinary Stent

Intervention

Drug:
• Naftopidil
Naftopidil 75mg 1T qd hs
• Placebo for Naftopidil
Placebo 1T qd hs
• Standard treatment
aceclofenac 100mg on demand

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Donguk University Ilsan Hospital	Goyang
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyunggi
Korea, Republic of	National Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	USSQ body pain score		at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)	No
Secondary	USSQ general health score		at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)	No
Secondary	USSQ work performance score		at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)	No
Secondary	USSQ sexual matters score		at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)	No
Secondary	International Prostate Symptom Score(IPSS), QoL score		at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)	No
Secondary	Total analgesics use		at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)	No