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

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

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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