Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.

Kaohsiung Medical University Chung-Ho Memorial Hospital70 enrolled

Overview

To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms.

I.Test drug 1. Name: Silodosin 8mg/capsule 2. Dosage form: capsule (Silodosin) 3. Dose(s): 8mg 4. Dosing schedule: Oral, once daily 5. Mechanism of action: Silodosin blocks the α1A-adrenergic receptors in the prostate gland and urethra, causing smooth muscle relaxation. Since the intraurethral pressure of the urethra is reduced, urine can pass more easily and the urinary symptoms are relieved. 6. Pharmacological category: α1A-adrenergic receptor blocker II.The process of the experiment (brief describe) Eligible subjects will be randomized to a study medication according to the randomization schedule (a 1:1 randomization ratio). There are 2 groups in this study, with group A (treatment group, silodosin 8mg, once daily, 8-week duration) and group B (control group). III. The primary endpoint is the rate of Foley removal. The secondary endpoints are the rate of urinary tract infection, residual urine amount and the rate of re-on Foley.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Human Trichinellosis

Interventions

Silodosin 8 mgDRUG

Dosing schedule: Oral, once daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject ≥ 20 years of age * Newly diagnosed of acute brain injury with Foley insertion with 5 days Exclusion Criteria: * Subjects with already in use of α1A-adrenergic receptor blocker used * Subjects with urethral trauma * Subjects with a history of prostate, penile, testicular, bladder, or urethral cancer or has received pelvic radiation, systemic chemotherapy, or intravesical chemotherapy * Expected survival days for brain injury less than 28 days * Subjects with a history of renal dysfunction (elevated creatinine (\>2.0 mg/dL)) * Subjects with severe liver impairment (Child-Pugh score≧10) * Subjects with CYP3A4 inhibitors (ketoconazole、clarithromycin、itraconazole、ritonavir) used * Subjects with pregnancy * Subject who has been in an investigational drug study in the past 3 months * Subjects who is considered as ineligible for participation in this clinical study by the principle investigator or the co-investigator's judgement.

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin District, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Assessment criteria Efficacy

Efficacy: the rate of Foley removal

Time frame: 56 day

Assessment criteria Safety

Silodosin-related adverse events

Time frame: 56 day

Secondary Outcomes

Assessment criteria Efficacy

Efficacy: the rate of urinary tract infection

Time frame: 56 day

Central Contacts

Chen Yu Chen, MS

CONTACT

0911884597 jennis7995@hotmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.