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

Neurogenic Lower Urinary Tract Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034604
• Other study ID #: 2013-02-043
• Status: Completed
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: August 2017

Study information

• Verified date: November 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurogenic Lower Urinary Tract Dysfunction

Intervention

Drug:
• Naftofidil

• Tamsulosin

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patients' symptom questionnaires	international prostate symptom score (IPSS) change, except QOL domain scores	from baseline to 8 weeks of treatment
Secondary	Changes in uroflow parameters	maximal flow rate, mean flow rate, voided volume and Changes in uroflowmetry parameters : maximal flow rate,mean flow rate, voided volume and PVR	from baseline to 8 weeks of treatment
Secondary	Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.		from baseline to 8 weeks of treatment
Secondary	Benefit, Satisfaction, and Willingness to Continue (BSW) questions		8 weeks after treatment
Secondary	Score of global response assessment for Korean, GRA-K		8 weeks after treatment
Secondary	Treatment satisfaction question, TSQ		8 weeks after treatment
Secondary	safety evaluation : incidence and severity of adverse events		up to 8 weeks
Secondary	change in each domain scores of IPSS		up to 8 weeks
Secondary	change in number of urinary frequency, nocturia		up to 8weeks