Can a newer prostate drug outperform the standard?
NCT ID NCT05551221
First seen Aug 21, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This trial tests whether silodosin, a medication that relaxes prostate and bladder muscles, works better than tamsulosin for men with an enlarged prostate and bothersome urinary symptoms. About 110 men aged 60 to 80 will take one of the two drugs for 12 weeks. Researchers will measure changes in symptom scores to see which drug provides more relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- silodosin
- What this could lead to
- If silodosin proves more effective or safer than tamsulosin, it could become a preferred treatment for men with enlarged prostate and urinary symptoms.
- What could go wrong
- This is a phase 4 trial with 110 participants, so results may not apply to everyone. Silodosin can cause side effects like dizziness, low blood pressure, and ejaculation problems.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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110 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 to 80 years
- 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: 1. Male Subjects aged 60 ~ 80 years, clinically diagnosed as benign prostatic hyperplasia. 2. Has an IPSS score ≥ 8 points at Screening and Baseline. 3. Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume \> 150 ml. 4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination. 5. Subjects who can read, understand, and complete the research questionnaire. 6. Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent. Exclusion Criteria: 1. Subjects with prostate cancer or other malignant tumors. 2. Subjects have serum tPSA \> 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA \< 0.16 times. 3. Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc. 4. Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications. 5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures. 6. Subjects have residual urine volume (PVR) \> 100ml, or those who may have urinary retention and need catheterization. 7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial. 8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial. 9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment. 10. Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases. 11. There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) \> 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L). 12. Subjects who are allergic to the drugs or ingredients used in the test definitely. 13. Any otherSubjects in the opinion of researchers is not suitable for inclusion.
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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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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
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The Central Hospital Of WUHAN
Wuhan, Hubei, China
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
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Wuhan No.1 Hospital
Wuhan, Hubei, China
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Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China
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