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

Recruiting

• Conditions: Human Trichinellosis
• Interventions: Drug: Silodosin 8 mg

• Registration Number: NCT06332235
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2022-02-18
• Status Verified: 2023-04
• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-27
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experiment group	Silodosin 8 mg	1. Subject ≥ 20 years of age 2. Newly diagnosed of acute brain injury with Foley insertion with 5 days

Primary Outcome Measures

Name	Time	Method
Assessment criteria Efficacy	56 day	Efficacy: the rate of Foley removal
Assessment criteria Safety	56 day	Silodosin-related adverse events

Secondary Outcome Measures

Name	Time	Method
Assessment criteria Efficacy	56 day	Efficacy: the rate of urinary tract infection

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Sanmin District, Taiwan