Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age50+
SponsorBeni-Suef University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Known or suspected prostate cancer.

Previous prostate surgery.

Previous urethral stricture disease or urethral surgery.

Neurogenic bladder or known neurological disease affecting voiding.

Trial design

Treatments tested in this trial

  • Tamsulosin 0.4 mg
  • Tamsulosin 0.8 mg
  • Silodosin 8 mg

Treatment groups

378 Participants
are divided into 3 treatment groups

Sponsors and collaborators