Clinical trial NCT06332235: Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Trichinellosis
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed of acute brain injury with Foley insertion with 5 days

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment criteria Efficacy
timeFrame: 56 day
measure: Assessment criteria Safety
timeFrame: 56 day
Secondary outcomes:
measure: Assessment criteria Efficacy
timeFrame: 56 day
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin District
Study officials:
affiliation: Affiliation
name: IRB
role: STUDY_CHAIR
References: