The Effect of Naftopidil for the Double-J Stent Discomfort

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Disorder of Urinary Stent

Treatments: Drug: Naftopidil; Drug: Placebo for Naftopidil; Drug: Standard treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01959074

SNUH-URO-2012-04-DJ (Other Identifier)

SNUH-URO-2012-04

Details and patient eligibility

About

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

Full 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)

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Naftopidil

Active Comparator group

Description:

This interventional group will receive analgesics and naftopidil 75mg po qd.

Treatment:

Drug: Standard treatment

Drug: Naftopidil

Control groups with only analgesics

Placebo Comparator group

Description:

Control groups will receive only analgesics

Treatment:

Drug: Standard treatment

Drug: Placebo for Naftopidil