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

Kaohsiung Medical University

Status: Enrolling

Conditions: Human Trichinellosis

Treatments: Drug: Silodosin 8 mg

Study type: Observational

Funder types: Other

Identifiers

NCT06332235

KMUHIRB-F(I)-20220023

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

Experiment group

Description:

1. Subject ≥ 20 years of age 2. Newly diagnosed of acute brain injury with Foley insertion with 5 days

Treatment:

Drug: Silodosin 8 mg