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

Sponsor
Beni-Suef University
Study ID
NCT07650968
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamsulosin 0.4 mg — DRUG
    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 — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
378 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tamsulosin 0.4 mg Continuation
    Participants will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
  • Experimental: Tamsulosin 0.8 mg Dose Escalation
    Participants will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
  • Experimental: Switch to Silodosin 8 mg
    Participants 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.

Primary Outcome Measure

Successful Trial Without Catheter at Day 7 [ Time Frame: Day 7, with assessment continuing for 24 hours after catheter removal ]

Central Contacts

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