Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-arm study compares three alpha-blocker strategies in men aged 50 and older who developed painful acute urinary retention while already taking tamsulosin 0.4 mg daily. After initial catheterization, participants are assigned to continue tamsulosin 0.4 mg, escalate to 0.8 mg, or switch to silodosin 8 mg for seven days before a trial without catheter is attempted. Catheter removal occurs on Day 7 and success is defined by spontaneous voiding with acceptable voided volume, low post-void residual urine, and no need for re-catheterization, with follow-up through Day 30. Outcomes include catheter-free status, recurrent retention, urinary flow, symptoms, adverse events, and subsequent BPH-related interventions. The study aims to identify the most effective pre-removal strategy to achieve catheter-free voiding in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.