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

NCT02034604 | Completed Phase 4

• 1 other identifier: 2013-02-043
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurogenic Lower Urinary Tract Dysfunction

Keywords

Naftopidil; safety

Outcome Measures

Primary Outcomes (1)

• Changes in patients' symptom questionnaires

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

  from baseline to 8 weeks of treatment

Secondary Outcomes (8)

• Changes in uroflow parameters

  from baseline to 8 weeks of treatment

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

  from baseline to 8 weeks of treatment

• Benefit, Satisfaction, and Willingness to Continue (BSW) questions

  8 weeks after treatment

• Score of global response assessment for Korean, GRA-K

  8 weeks after treatment

• Treatment satisfaction question, TSQ

  8 weeks after treatment

Study Arms (2)

Naftopidil Group

EXPERIMENTAL

Naftopidil medication patients

Drug: Naftofidil

Tamsulosin Goup

ACTIVE COMPARATOR

Tamsulosin medication patients

Drug: Tamsulosin

Interventions

Naftofidil DRUG

Naftopidil Group

Tamsulosin DRUG

Tamsulosin Goup

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 130-710, South Korea

Location

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor,MD,PhD

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 13, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

KR (1)