Which prostate pill works best after a catheter? new study aims to find out
NCT ID NCT07650968
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at men over 50 with an enlarged prostate who had a sudden inability to urinate and needed a catheter. All were already taking tamsulosin 0.4 mg daily. The trial compares three options over 7 days: staying on the same dose, doubling it, or switching to silodosin. The goal is to see which strategy most helps men urinate successfully after the catheter is removed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tamsulosin and silodosin
- What this could lead to
- If successful, this could identify the best medication approach to help men avoid a catheter after a sudden urine blockage from an enlarged prostate.
- What could go wrong
- This is a small, short-term study (7 days of treatment) and results may not apply to all men. Side effects like dizziness or low blood pressure are possible with these drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 378 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Successful urethral catheterization at presentation. * Initial catheterized urine volume ≤1000 mL, with a clinical presentation consistent with painful acute urinary retention. * Prostate enlargement on ultrasound or clinical assessment consistent with benign prostatic hyperplasia or benign prostatic obstruction. * Ability to provide written informed consent. Exclusion Criteria: * Known or suspected prostate cancer. * Previous prostate surgery. * Previous urethral stricture disease or urethral surgery. * Neurogenic bladder or known neurological disease affecting voiding. * Chronic urinary retention rather than acute painful retention. * Acute urinary retention due to non-BPH causes, including clot retention, bladder stone obstruction, acute prostatitis, urethral trauma, or drug-induced retention. * Severe urinary tract infection, sepsis, or fever at presentation. * Gross hematuria requiring irrigation. * Failed urethral catheterization or need for suprapubic catheterization. * Current use of silodosin, alfuzosin, doxazosin, terazosin, tadalafil, anticholinergics, beta-3 agonists, or other drugs that may significantly affect voiding. * Severe renal impairment requiring urgent intervention. * Symptomatic postural hypotension or recurrent syncope. * Known hypersensitivity to silodosin. * Severe hepatic impairment. * Inability to comply with follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Urology- Beni-Suef University Hospitals
RECRUITINGBanī Suwayf, Beni Suweif Governorate, 02456, Egypt
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