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

Phase 4

Completed

• Conditions: Neurogenic Lower Urinary Tract Dysfunction
• Interventions: Drug: Naftofidil; Drug: Tamsulosin

• Registration Number: NCT02034604
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Primary Completion: 2016-12
• Study Completion: 2017-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naftopidil Group	Naftofidil	Naftopidil medication patients
Tamsulosin Goup	Tamsulosin	Tamsulosin medication patients

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Score of global response assessment for Korean, GRA-K	8 weeks after treatment
Treatment satisfaction question, TSQ	8 weeks after treatment
safety evaluation : incidence and severity of adverse events	up to 8 weeks
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
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
change in number of urinary frequency, nocturia	up to 8weeks
change in each domain scores of IPSS	up to 8 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of