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

Last updated: March 19, 2024
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Interstitial Cystitis

Treatment

Silodosin 8 mg

Clinical Study ID

NCT06332235
KMUHIRB-F(I)-20220023
  • Ages 20-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 canceror 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 bythe principle investigator or the co-investigator's judgement.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Silodosin 8 mg
Phase:
Study Start date:
February 18, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, Sanmin District 807
    Taiwan

    Active - Recruiting

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