Skip to main content
OpenTrials
Completed

NCT Number: NCT02034604

Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia

This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neurogenic Lower Urinary Tract Dysfunction

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 130-710, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged 20 years old and above (upper limit of age: 80 years old)
  • patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
  • a+b
  • IPSS ≥ 12 and QoL ≥ 3
  • Maximum Flow Rate <15 mL/s (Voiding volume) ≥ 120mL)
  • Ability and willingness to correctly complete the micturition diary and questionnaire
  • Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion criteria

  • In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
  • In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
  • In female, the history of anti-incontinence operation.
  • Patients with cancer of any type including cancer of the prostate or bladder
  • Patients with urethral stricture or bladder neck contracture

Treatment and study plan

Naftofidil

Drug

Tamsulosin

Drug

Primary outcomes

  1. Changes in patients' symptom questionnaires

    Time frame: from baseline to 8 weeks of treatment

    international prostate symptom score (IPSS) change, except QOL domain scores

Secondary outcomes

  1. Changes in uroflow parameters

    Time frame: from baseline to 8 weeks of treatment

    maximal flow rate, mean flow rate, voided volume and Changes in uroflowmetry parameters : maximal flow rate,mean flow rate, voided volume and PVR

  2. Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.

    Time frame: from baseline to 8 weeks of treatment

  3. Benefit, Satisfaction, and Willingness to Continue (BSW) questions

    Time frame: 8 weeks after treatment

  4. Score of global response assessment for Korean, GRA-K

    Time frame: 8 weeks after treatment

  5. Treatment satisfaction question, TSQ

    Time frame: 8 weeks after treatment

  6. safety evaluation : incidence and severity of adverse events

    Time frame: up to 8 weeks

  7. change in each domain scores of IPSS

    Time frame: up to 8 weeks

  8. change in number of urinary frequency, nocturia

    Time frame: up to 8weeks

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 13, 2014
Registry last updated
Dec 2, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.