Can a pill combo spare men from a catheter after a urinary emergency?
NCT ID NCT07654413
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding tadalafil (a daily pill for erection problems and enlarged prostate) to standard tamsulosin helps men aged 50+ who suddenly can't urinate due to an enlarged prostate. After a catheter is placed, participants take either tamsulosin plus tadalafil or tamsulosin plus a placebo for up to 14 days. The main goal is to see if more men can urinate on their own and stay catheter-free by day 14.
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 tadalafil
- What this could lead to
- If it works, this could offer a better way to help men with an enlarged prostate avoid a catheter after a sudden inability to urinate.
- What could go wrong
- This is a phase 4 trial, so the drugs are already approved, but the combination may not improve success rates and could cause side effects like headache or dizziness.
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 320 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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Dec 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 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.
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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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