Comparative Study Between Fixed Dose Monotherapy (Phosphodiesterase 5 Inhibitors or Alpha Blockers) Versus Combined Therapy in Benign Prostatic Hyperplasia Patients With Lower Urinary Tract Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Change in International index of erectile function (IIEF) after 12 weeks
研究概览
简要总结
To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.
详细描述
The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia .
Benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS).
Alpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011.
The PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH.
Medical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1 - Men > 45 years with LUTS/BPH for > 6 months 2- IPSS of ≥ 8 and Qmax of ≥ 4 to≤ 15 mL/s
排除标准
- •PSA level of > 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).
- •Post-voidresidual urine volume of ≥ 150 mL.
- •Previous Urine Retention or Urethral Catheterization .
- •other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .
- •Any case of LUTS other than BPH (urinary bladder stone, neurogenic bladder, bladder neck contracture,rethral stricture, bladder cancer, acute or chronic prostatitis, acute or chronic urinary tract infection).
- •patients supposed to undergo intraocular operation (as cataract operation) .
- •History of head injury or cerebrovascular stroke or spinal injury.
- •pelvic fracture.
- •Uncontrolled diabetic patient.
- •Patients with chronic obstructive lung disease on medical treatment.
- •Parasympatholytic drugs are contraindicated during the study.
- •Patients refusing to share in the study.
研究组 & 干预措施
Group A
Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks.
干预措施: Alpha Blockers (Drug)
Group B
Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks.
干预措施: Phosphodiesterase 5 Inhibitors (Drug)
Group C
Forty patients with LUTS due to BPH will be given combined therapy(tamsulosin 0.4 mg and tadalafil 5 mg) for 12 weeks.
干预措施: Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors (Drug)
结局指标
主要结局
Change in International index of erectile function (IIEF) after 12 weeks
时间窗: At start of study and after 12 weeks from drug intake
The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity.
Change in Maximal urinary flow rate (Qmax) after 12 weeks
时间窗: At start of study and after 12 weeks from drug intake
The flow rate is calculated as milliliters (ml) of urine passed per second. Both average and top flow rates are measured. The fastest flow rate, also known as Qmax, is used to understand if a block or obstruction is severe.
Change in International prostate symptom score (IPSS) after 12 weeks
时间窗: At start of study and after 12 weeks from drug intake
The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
次要结局
未报告次要终点
研究者
Ahmed Mostafa Hussein Mostafa
Principle Investigator
Assiut University