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Recruiting NCT07654413

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

Phase IV Interventional Acute Urinary Retention Benign Prostatic Hyperplasia Benign Prostatic Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tamsulosin, Tadalafil, Tadalafil Placebo.
Who it may be relevant to
Registry conditions: Acute Urinary Retention, Benign Prostatic Hyperplasia, Benign Prostatic Obstruction. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

Overview

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.

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.

Primary outcome measures

  • Overall Catheter-Free Success by Day 14 [Time frame: Day 14]
Secondary outcome measures (4)
  • Successful Day-7 Trial Without Catheter [Time frame: Day 7]
  • Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures [Time frame: Day 14]
  • Recurrent Acute Urinary Retention Within 30 Days [Time frame: 30 days]
  • Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Male patient aged 50 years or older.
  • First episode of spontaneous painful acute urinary retention.
  • Successful urethral catheterization at presentation.
  • Drained urine volume at presentation of at least 300 mL.
  • Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
  • Ability to provide written informed consent.

Exclusion criteria

  • Previous episode of acute urinary retention.
  • Chronic painless urinary retention phenotype.
  • Active urinary tract infection or sepsis.
  • Gross hematuria with clot retention.
  • Suspected or known urethral stricture.
  • Neurogenic bladder or major neurologic disease affecting voiding.
  • History of prostate cancer or bladder cancer.
  • Previous prostate surgery.
  • Current use of nitrates or guanylate cyclase stimulators.
  • Contraindication to tadalafil or tamsulosin.
  • Severe hypotension or unstable cardiovascular disease.
  • Severe renal impairment.
  • Severe hepatic impairment.
  • Current or recent use of phosphodiesterase type 5 inhibitors before enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Identifiers

NCT: NCT07654413 · BSU FMBSUREC07062026CBADAWY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗