Tamsulosin 0.4 mg: Participants assigned to this intervention will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Tamsulosin 0.8 mg: Participants assigned to this intervention will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Silodosin 8 mg: Participants assigned to this intervention will stop tamsulosin 0.4 mg and switch to silodosin 8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Study summary
This randomized controlled trial will compare three medication strategies before trial without catheter in men with acute urinary retention due to benign prostatic hyperplasia who were already taking tamsulosin 0.4 mg once daily before the retention episode. After urethral catheterization, eligible participants will be randomly assigned to one of three groups for 7 days: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily. The urethral catheter will be removed on Day 7, and the ability to void successfully without re-catheterization will be assessed. Follow-up will continue to Day 30, with additional recording of catheter-free status, recurrent urinary retention, urinary flow, post-void residual urine, symptom scores, adverse drug events, catheter-related complications, and the need for later benign prostatic hyperplasia-related surgery.
Eligibility
Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male patients aged 50 years or older.
* Acute urinary retention requiring urethral catheterization.
* Presumed acute urinary retention secondary to benign prostatic enlargement or benign prostatic obstruction.
* Already receiving tamsulosin 0.4 mg once daily for at least 4 weeks before the acute urinary retention episode.
* Successful urethral catheterization at presentation.
* Initial catheterized urine volume ≤1000 mL, with a clinical presentation consistent with painful acute urinary retention.
* Prostate enlargement on ultrasound or clinical assessment consistent with benign prostatic hyperplasia or benign prostatic obstruction.
* Ability to provide written informed consent.
Exclusion Criteria:
* Known or suspected prostate cancer.
* Previous prostate surgery.
* Previous urethral stricture disease or urethral surgery.
* Neurogenic bladder or known neurological disease affecting voiding.
* Chronic urinary retention rather than acute painful retention.
* Acute urinary retention due to non-BPH causes, including clot retention, bladder stone obstruction, acute prostatitis, urethral trauma, or drug-induced retention.
* Severe urinary tract infection, sepsis, or fever at presentation.
* Gross hematuria requiring irrigation.
* Failed urethral catheterization or need for suprapubic catheterization.
* Current use of silodosin, alfuzosin, doxazosin, terazosin, tadalafil, anticholinergics, beta-3 agonists, or other drugs that may significantly affect voiding.
* Severe renal impairment requiring urgent intervention.
* Symptomatic postural hypotension or recurrent syncope.
* Known hypersensitivity to silodosin.
* Severe hepatic impairment.
* Inability to comply with follow-up.
Primary outcome measure(s)
Successful Trial Without Catheter at Day 7 — Day 7, with assessment continuing for 24 hours after catheter removal Proportion of participants with successful Trial Without Catheter at Day 7. Success is defined as spontaneous voiding within 6 hours after urethral catheter removal, voided volume ≥100 mL, post-void residual urine \<150 mL measured by ultrasound within 10-15 minutes after voiding, no painful bladder distension or clinically significant voiding difficulty requiring immediate re-catheterization, and no need for re-catheterization within 24 hours after catheter removal.
Trial sites (1)
Facility
City
Region
Status
Department of Urology- Beni-Suef University Hospitals
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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