Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia

Sponsor
Beni-Suef University
Study ID
NCT07654413
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Tamsulosin — DRUG
    Tamsulosin 0.4 mg will be administered orally once daily as open-label background therapy in both study arms. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
  • Tadalafil — DRUG
    Tadalafil 5 mg will be administered orally once daily in the experimental arm in addition to open-label tamsulosin 0.4 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
  • Tadalafil Placebo — DRUG
    A matching placebo tablet will be administered orally once daily in the placebo comparator arm in addition to open-label tamsulosin 0.4 mg once daily. The placebo will be identical to tadalafil in appearance, packaging, and labeling to maintain blinding.

Study Details

Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization. This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia. Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14. The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.

Key Dates

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

Study Design

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

Arms

  • Placebo Comparator: Tamsulosin Plus Placebo
    Participants will receive tamsulosin 0.4 mg once daily plus a matching placebo once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
  • Experimental: Tamsulosin Plus Tadalafil
    Participants will receive tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.

Primary Outcome Measure

Overall Catheter-Free Success by Day 14 [ Time Frame: Day 14 ]

Central Contacts

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