Benign Prostatic Hyperplasia With Lower Urinary Tract SymptomsPhase 4NCT05551221
The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
A Phase 4 study testing Silodosin Capsules and Tamsulosin in people with Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Xintian Pharmaceutical at 8 sites in China.
Trial summary
Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
- What is being tested?
- Silodosin Capsules and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesChina
- Study dates
- 21 Sep 2022to 10 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
- Has an IPSS score ≥ 8 points at Screening and Baseline.
- Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
- Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
- Subjects who can read, understand, and complete the research questionnaire.
- Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.
Who cannot join
- Subjects with prostate cancer or other malignant tumors.
- Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
- Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- 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.
- Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
- Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization.
Show all 13Show fewer
- Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
- Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
- Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
- Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
- 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).
- Subjects who are allergic to the drugs or ingredients used in the test definitely.
- Any otherSubjects in the opinion of researchers is not suitable for inclusion.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Peking University Shenzhen Hospital
Shenzhen, Guangdong
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The Central Hospital Of WUHAN
Wuhan, Hubei
Wuhan No.1 Hospital
Wuhan, Hubei
Wuxi No.2 People's Hospital
Wuxi, Jiangsu
About this study
Official title: The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study
Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules.
Study design: A multicenter, prospective, randomized, investigator-blind, active controlled clinical study.
Interventions:
Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
Read the detailed description
Sample size: 108
- Being tested
- Silodosin Capsules, Tamsulosin
- Keywords
- Benign Prostatic Hyperplasia Silodosin Capsules, Silodosin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silodosin CapsulesDrug
Also called Qianweitai
Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner.
TamsulosinDrug
Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin Hydrochloride Capsules | Active comparator | Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) Receives: Drug: Tamsulosin |
| Silodosin Capsules | Experimental | Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) Receives: Drug: Silodosin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score（IPSS）
Changes of IPSS scores at the 12th week of treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
Measured: 12 week
Secondary outcomes (8)
International Prostate Symptom Score（IPSS） total score
Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
Measured: 1, 2, 4 and 8 weeks
IPSS Stimulus score
IPSS Stimulation Score at 12 weeks (Sum of Question 2, 4, 7) compared with baseline. The scores of the scale ranged from 0 to 15. The higher the score, the more severe the symptoms are.
Measured: 12 weeks
IPSS obstruction score
Changes of IPSS obstruction score (sum of question 1, 3, 5, 6) at 12 weeks after treatment compared with baseline. The scores of the scale ranged from 0 to 20. The higher the score, the more severe the symptoms are.
Measured: 12 weeks
IPSS total score severity
Distribution of IPSS total score severity grades at 12 weeks. The scores of the scale were divided into three grades: mild (0-7), moderate (8-19) and severe (20-35).
Measured: 12 week
Quality of life (QoL) score
Changes in scores at 4, 8 and 12 weeks of treatment compared with baseline.The scores of the scale ranged from 0 to 6. The higher the score, the more severe the symptoms are.
Measured: 4, 8 and 12 weeks
Maximum urinary flow rate (Qmax)
The change of Qmax at 12 weeks of treatment compared with baseline.
Measured: 12 weeks
Residual urine volume (PVR)
Changes of PVR at 12 weeks of treatment compared with baseline.
Measured: 12 weeks
Patient response rate
Patient response rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% compared with baseline value after treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start21 Sep 2022
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia With Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xintian Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongguo Chen, MD, Study chair, employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551221
- Sponsor's protocol ID
- TREC2022-17
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study
- ClinicalTrials.gov ID
- NCT05551221
- Acronym / sponsor ID
- TREC2022-17
- Keywords
- Benign Prostatic Hyperplasia Silodosin Capsules, Silodosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Xintian PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules.
Study design: A multicenter, prospective, randomized, investigator-blind, active controlled clinical study.
Interventions:
Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
Detailed description
Sample size: 108
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: Oral Tamsulosin Hydrochloride Capsules for 12 weeks. Group B: Oral l Silodosin Capsules for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Hydrochloride Capsules | Active comparator | Drug: TamsulosinPatients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) |
| Silodosin Capsules | Experimental | Drug: Silodosin CapsulesPatients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
- Has an IPSS score ≥ 8 points at Screening and Baseline.
- Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
- Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
- Subjects who can read, understand, and complete the research questionnaire.
Key exclusion criteria (13 listed)
- Subjects with prostate cancer or other malignant tumors.
- Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
- Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- 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.
- Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silodosin CapsulesAlso: QianweitaiSilodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner. | Drug | Silodosin Capsules |
| TamsulosinTamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day. | Drug | Tamsulosin Hydrochloride Capsules |
Primary outcome
International Prostate Symptom Score（IPSS）
Time frame: 12 week
Changes of IPSS scores at the 12th week of treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
8 secondary outcomes
International Prostate Symptom Score（IPSS） total score
Time frame: 1, 2, 4 and 8 weeks
IPSS Stimulus score
Time frame: 12 weeks
IPSS obstruction score
Time frame: 12 weeks
IPSS total score severity
Time frame: 12 week
Quality of life (QoL) score
Time frame: 4, 8 and 12 weeks
Maximum urinary flow rate (Qmax)
Time frame: 12 weeks
Residual urine volume (PVR)
Time frame: 12 weeks
Patient response rate
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongguo Chen, MD study chair
employee
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin Capsules and Tamsulosin in people with Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms, run by Xintian Pharmaceutical at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score（IPSS） (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.