The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (NQTIPS)

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: Tamsulosin; Drug: Silodosin Capsules

Detailed Description

Sample size: 108

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Tongren Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China
      • Beijing Tiantan Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University
    • Shenzhen, Guangdong, China
      • Peking University Shenzhen Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan No.1 Hospital
    • Wuhan, Hubei, China
      • The Central Hospital of Wuhan
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China
      • Wuxi No.2 People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tamsulosin Hydrochloride Capsules; Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily)	Drug: Tamsulosin; 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.
Experimental: Silodosin Capsules; Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner)	Drug: Silodosin Capsules; 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.; Other Names: Qianweitai

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 2, 4 and 8 weeks
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.	4, 8 and 12 weeks
Maximum urinary flow rate (Qmax)	The change of Qmax at 12 weeks of treatment compared with baseline.	12 weeks
Residual urine volume (PVR)	Changes of PVR at 12 weeks of treatment compared with baseline.	12 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.	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.	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).	12 week
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.	12 weeks

Collaborators and Investigators

• Sponsor: Xintian Pharmaceutical
• Investigators: Study Chair: Zhongguo Chen, MD, employee

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): September 10, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Silodosin; Benign Prostatic Hyperplasia Silodosin Capsules
• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Sulfones; Tamsulosin; silodosin
• Other Study ID Numbers: TREC2022-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No