CTRI/2019/11/021996尚未招募未知
Efficacy of Silodosin versus Tamsulosin in lower urinary tract (LUTS) symptoms due to BPH- A Randomised Open Label Clinical Study
niversity College of Medical Sciences University of Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.All patients aged 45-80 years giving informed
- •consent to participate in the study.
- •2.Patients with LUTS/ IPSS >8 due to BPH without
- •any absolute indication for surgery.
- •3.Patients with enlarged prostate gland less than
- •or equal to 30gm on either clinical examination
- •or ultrasound assessment.
- •4.Patients with previously diagnosed BPH not on
- •any medical therapy (patients on alpha blockers
- •will be given 2-week drug washout prior to
- •enrollment).
排除标准
- •1.Patients with mental disorders or illness who
- •cannot understand or comply with the study
- •2. BPH with complications like CRF,
- •hydronephrosis, acute bacterial prostatitis,
- •3.Patients with LUTS and or bladder outlet
- •obstruction due to causes other than BPH.
- •4.Patients with known drug allergy/
- •contraindications to tamsulosin & or silodosin. 5.Patients taking nitrates for CYP3A4 inhibitors
- •(ketoconazole, ritonavir) and CYP3A4 inducers
- •(rifampicin). Patients with previous history of
- •prostate surgery, diagnosed cancer prostate.
- •6. Patients on 5 alpha reductase inhibitor
- •7.Patients with severe cardiac, hepatic or renal
- •insufficiency.
- •8.Patients with active untreated UTI,
- •urolithiasis, PVR >200mls, patients in whom
- •cystoscopy or biopsy has been done from urinary
- •tract in the past 2 weeks urethral stricture
- •disease, neurogenic bladder, prostate or
- •urethral surgery, any previous history of
- •continuous intermittent catheterization, h/o
- •postural hypotension, patients with uncontrolled
- •severe hypertension. H/O treatment with
- •verapamil, androgens, anti androgens, diuretics,
- •cholinergics, anticholinergics, phytotherapy in
- •the past 3 months, h/o alcohol abuse,malignancy.
- •9.Patients with h/o any conditions exposing them
- •to increased risk of adverse effects of
- •silodosin including any serious life threatening
- •cardiovascular, renal, neurological, hepatic.
- •10. Any other disease or condition and any other
- •systemic illness or disorder which in the
- •clinical judgement of the investigator is/are
- •deemed risky.
研究者
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