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

ConditionsAcute Urinary RetentionBenign Prostatic Hyperplasia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

378 Participants
are divided into 3 treatment groups
Group A: Tamsulosin 0.4 mg ContinuationActive comparator 1 intervention
Group B: Tamsulosin 0.8 mg Dose EscalationExperimental treatment 1 intervention
Group C: Switch to Silodosin 8 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful Trial Without Catheter at Day 7

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.

Time frame
Day 7, with assessment continuing for 24 hours after catheter removal

Secondary outcomes

1

Catheter-Free Status at Day 14

Proportion of participants who are free from an indwelling urinary catheter at Day 14 after randomization, including participants who undergo rescue Trial Without Catheter after initial Day-7 failure.

Time frame
Day 14
2

Recurrent Acute Urinary Retention Within 30 Days

Proportion of participants who develop recurrent acute urinary retention requiring re-catheterization after initially successful Trial Without Catheter.

Time frame
Up to 30 days
3

Adverse Drug Events

Proportion of participants with adverse drug events, including dizziness, postural hypotension, syncope, headache, nasal congestion, abnormal ejaculation, diarrhea, allergic reaction, or other clinically significant drug-related adverse events.

Time frame
Up to 30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov
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