Can adjusting drug schedules improve both urinary and sexual outcomes in men with enlarged prostate?
NCT ID NCT07715448
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This clinical trial investigates whether different dosing schedules of tadalafil or tamsulosin, when combined with a 5-alpha reductase inhibitor, can better manage urinary symptoms and preserve sexual function in men with benign prostatic hyperplasia (BPH). The study includes 240 men aged 50 and older with moderate to severe symptoms and an enlarged prostate. Over 12 weeks, researchers will measure changes in urinary symptoms, erectile function, and ejaculatory function to find the optimal combination regimen.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tadalafil or tamsulosin combined with a 5-alpha reductase inhibitor (finasteride or dutasteride)
- What this could lead to
- If successful, this could identify the most effective dosing regimen to improve both urinary symptoms and sexual function in men with an enlarged prostate.
- What could go wrong
- This is a single-blind, 12-week study with 240 participants, so results may not apply to all men or longer-term use. Side effects from these drugs can include dizziness, low blood pressure, and sexual side effects.
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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240 people
The number who actually took part.
- Finished
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Jan 2026
- 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 participants aged 50 years or older. * Newly diagnosed with benign prostatic hyperplasia (BPH). * Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) \> 7. * Prostate volume \>40 mL confirmed by transrectal ultrasonography (TRUS). * Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score \>10. * Prostate-specific antigen (PSA) \<4 ng/mL and no suspicious findings on digital rectal examination (DRE). * Able and willing to provide written informed consent. Exclusion Criteria: * History of prostate cancer. * Previous prostate surgery. * Abnormal digital rectal examination suggestive of malignancy. * Severe erectile dysfunction (IIEF-EF score ≤10). * Uncontrolled diabetes mellitus. * Uncontrolled cardiovascular disease. * Neurological disorders affecting bladder function. * Renal impairment. * Hepatic impairment. * Active urinary tract infection. * Bladder stones or other significant urological pathology. * Known hypersensitivity to tamsulosin, tadalafil, or 5-alpha reductase inhibitors. * Patients actively seeking fertility treatment. * Current use of medications known to significantly affect sexual function. * Concurrent use of nitrates or contraindicated antihypertensive medications.
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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.
Contacts and locations
Locations
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Beni-Suef University Hospital
Banī Suwayf, Beni Suef Governorate, Egypt
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