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

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Samsung Medical Center

Status and phase

Completed
Phase 4

Conditions

Neurogenic Lower Urinary Tract Dysfunction

Treatments

Drug: Tamsulosin
Drug: Naftofidil

Study type

Interventional

Funder types

Other

Identifiers

NCT02034604
2013-02-043

Details and patient eligibility

About

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.

Enrollment

194 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female aged 20 years old and above (upper limit of age: 80 years old)

  2. patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)

  3. a+b

    1. IPSS ≥ 12 and QoL ≥ 3
    2. Maximum Flow Rate <15 mL/s (Voiding volume) ≥ 120mL)
  4. Ability and willingness to correctly complete the micturition diary and questionnaire

  5. 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

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

194 participants in 2 patient groups

Naftopidil Group
Experimental group
Description:
Naftopidil medication patients
Treatment:
Drug: Naftofidil
Tamsulosin Goup
Active Comparator group
Description:
Tamsulosin medication patients
Treatment:
Drug: Tamsulosin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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