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Completed

NCT Number: NCT01959074

The Effect of Naftopidil for the Double-J Stent Discomfort

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

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Key information

Conditions

Disorder of Urinary Stent

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam, Kyunggi, South Korea

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About this study

  • Enrollment
  • patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
  • patients aged more than 20 years
  • Randomization
  • naftopidil 75 mg qd or placebo until Double-J stent removal
  • Standard treatment with pain-killers on demand were also applied.(aceclofenac)
  • Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naftopidil

Drug

Naftopidil 75mg 1T qd hs

Other names: Flivas(TM) in South Korea

Placebo for Naftopidil

Drug

Placebo 1T qd hs

standard treatment

Drug

aceclofenac 100mg on demand

Other names: Aceclofenac

Primary outcomes

  1. Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score

    Time frame: 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.

  2. USSQ body pain score

    Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

Secondary outcomes

  1. USSQ general health score

    Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  2. USSQ work performance score

    Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  3. USSQ sexual matters score

    Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  4. International Prostate Symptom Score(IPSS), QoL score

    Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

  5. Total analgesics use

    Time frame: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A ST Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2013
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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