NCT06332235

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

A Randomized Open Label Phase-II Control Trial to Evaluate the Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Human Trichinellosis

Interventions

Type	Name	Description
DRUG	Silodosin 8 mg	Dosing schedule: Oral, once daily

Timeline

• Start date: 2022-02-18
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: Taiwan