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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Naftopidil; Tamsulosin

Criteria

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