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

NCT07654413 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-06-17

No results posted yet for this study

Summary

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.

Conditions

  • Acute Urinary Retention
  • Benign Prostatic Hyperplasia
  • Benign Prostatic Obstruction

Interventions

DRUG

Tamsulosin

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.

DRUG

Tadalafil

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.

DRUG

Tadalafil Placebo

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.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2027-11-30
Completion
2027-12-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654413 on ClinicalTrials.gov