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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02034604
• Collaborator: (none)
• Enrollment: 194
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Lower Urinary Tract Dysfunction	Drug: Naftofidil; Drug: Tamsulosin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naftopidil Group Naftopidil medication patients	Drug: Naftofidil
Active Comparator: Tamsulosin Goup Tamsulosin medication patients	Drug: Tamsulosin

Outcome Measures

Primary Outcome Measures

1. Changes in patients' symptom questionnaires [from baseline to 8 weeks of treatment]

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

Secondary Outcome Measures

1. Changes in uroflow parameters [from baseline to 8 weeks of treatment]

   maximal flow rate, mean flow rate, voided volume and Changes in uroflowmetry parameters : maximal flow rate,mean flow rate, voided volume and PVR

2. Change in proportion of patients showed an improvement in IPSS total scores of more than 25%. [from baseline to 8 weeks of treatment]

3. Benefit, Satisfaction, and Willingness to Continue (BSW) questions [8 weeks after treatment]

4. Score of global response assessment for Korean, GRA-K [8 weeks after treatment]

5. Treatment satisfaction question, TSQ [8 weeks after treatment]

6. safety evaluation : incidence and severity of adverse events [up to 8 weeks]

7. change in each domain scores of IPSS [up to 8 weeks]

8. change in number of urinary frequency, nocturia [up to 8weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

4. IPSS ≥ 12 and QoL ≥ 3

5. Maximum Flow Rate <15 mL/s (Voiding volume) ≥ 120mL)

6. Ability and willingness to correctly complete the micturition diary and questionnaire

7. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	130-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02034604
• Other Study ID Numbers: 2013-02-043
• First Posted: Jan 13, 2014
• Last Update Posted: Dec 2, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center: Naftopidil; safety
• Additional relevant MeSH terms: Tamsulosin

Study Results

No Results Posted as of Dec 2, 2019