The effect of Naftopidil for the double-J stent discomfort after urinary stone surgery

The effect of Naftopidil for the double-J stent discomfort: Multicenter, randomized, double-blind, placebo controlled study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001194

Enrollment

100

Registered

2014-08-06

Start date

2014-05-22

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Naftopidil, 75mg, 1T, QD, oral ingestion vs Placebo 1T QD, oral ingestion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria: 2. Exclusion after percutaneous nephrolithotomy, open or laparaoscopic ureterolithotmoy presence of ureteral stone renal insufficiency (serun Cr > 1.4) febrile UTI (fever > 38 degree) 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 hypatic dysfunction prior history of pelvic surgery or irradiation prior history of TURBT 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 amlabsorption

Design outcomes

Primary

Measure	Time frame
USSQ urinary symptom score;USSQ body pain score	—

Secondary

Measure	Time frame
USSQ general health score;USSQ work performance score;USSQ sexual matters score;international prostate symptom score;Total analgesics use	—

Countries

Korea, Republic of

Contacts

Public ContactJanghee Han

Seoul National University Hospital

jhhan2013@snu.ac.kr+82-2-6072-5262

Outcome results