The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH (NCT07134907) | Clinical Trial Compass
CompletedPhase 4
The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH
China110 participantsStarted 2022-07-18
Plain-language summary
The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are:
1. Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？
2. Dose QWT have other advantages in the improvement of LUTS?
Participants will:
1. Orally take QWT twice daily or tamsulosin once daily for 12 weeks.
2. Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.
Who can participate
Age range60 Years – 80 Years
SexMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. 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.