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Status unknownNCT06332235Updated Mar 27, 2024

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

An observational study in Human Trichinellosis, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-27.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
70
Ages
20 Years to 100 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Human Trichinellosis
03

In context

Lower Urinary Tract Symptoms

406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's planned enrollment of 70 is below the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Experiment group

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

    Drug: Silodosin 8 mg

Interventions

  • DrugSilodosin 8 mg

    Dosing schedule: Oral, once daily

    Also known as: Conventional treatment

06

What researchers measure

Primary outcomes

  1. Assessment criteria Efficacy

    Efficacy: the rate of Foley removal

    Time frame: 56 day

  2. Assessment criteria Safety

    Silodosin-related adverse events

    Time frame: 56 day

Secondary outcomes

  1. Assessment criteria Efficacy

    Efficacy: the rate of urinary tract infection

    Time frame: 56 day

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Sanmin District 807, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06332235
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Feb 18, 2022
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 27, 2024

Study contacts

Chen Yu Chen, MS
Contact
jennis7995@hotmail.com
0911884597
IRB
study chair · Affiliation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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