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.

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

Study Overview

• Status: Recruiting
• Conditions: Human Trichinellosis
• Intervention / Treatment: Drug: Silodosin 8 mg

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Chen Yu Chen, MS; Phone Number: 0911884597; Email: jennis7995@hotmail.com

Study Locations

• Taiwan
  • Sanmin District
    • Kaohsiung, Sanmin District, Taiwan, 807
      • Recruiting
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Contact: Chen Yu Chen, MS; Phone Number: 0911884597; Email: jennis7995@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Newly diagnosed of acute brain injury with Foley insertion with 5 days

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experiment group; Subject ≥ 20 years of age; Newly diagnosed of acute brain injury with Foley insertion with 5 days	Drug: Silodosin 8 mg; Dosing schedule: Oral, once daily; Other Names: Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment criteria Efficacy	Efficacy: the rate of Foley removal	56 day
Assessment criteria Safety	Silodosin-related adverse events	56 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment criteria Efficacy	Efficacy: the rate of urinary tract infection	56 day

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Chair: IRB, Affiliation

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urological Manifestations; Parasitic Diseases; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Lower Urinary Tract Symptoms; Trichinellosis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: KMUHIRB-F(I)-20220023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No