Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4, randomized trial compares tamsulosin alone versus tamsulosin plus tadalafil in men 50 and older who have had acute urinary retention due to benign prostatic obstruction. After initial catheter drainage, participants start their study medications within 24 hours and attempt to void without a catheter by day 7; a second trial without catheter may occur on day 14 if the first attempt fails. The primary outcome is catheter-free success by day 14, with follow-up for recurrent retention. The study is conducted at Beni-Suef University Hospital in Egypt and uses a tadalafil/placebo control to determine if combination therapy improves TWOC outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.