Safety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- SHIM questionnaire
研究概览
简要总结
Introduction Sexual dysfunctions are annoying health problems with the erectile problems forming the main part of them. Erectile dysfunction (ED) is defined as the persistent inability to obtain or maintain an erection that is sufficient to allow satisfactory sexual intercourse.[1] Aim of Work To evaluate the role of L-arginine monotherapy versus Tadalafil monotherapy versus their combination for the treatment of erectile dysfunction .
Patients and methods:
Inclusion criteria:
• Naive ( not previously treated) male patient with mild to moderate ED according to SHIM Questionnaire.
Exclusion criteria:
- Kidney disease or liver failure
- Coronary heart disease
- Peyronie's disease
- Neurological disease that may related to ED
详细描述
Safety And Efficacy Of L-Arginine Monotherapy Versus Tadalafil Monotherapy Versus Their Combination In Men With Erectile Dysfunction; A Prospective Randomized Study
Introduction Sexual dysfunctions are annoying health problems with the erectile problems forming the main part of them. Erectile dysfunction (ED) is defined as the persistent inability to obtain or maintain an erection that is sufficient to allow satisfactory sexual intercourse.[1] It is difficult to obtain accurate values for the true prevalence of erectile dysfunction, as many patients fail to seek any medical attention The best available data according to the Massachusetts Male Aging Study indicates that 52% of males between 40 and 70 years of age are affected with erectile problems, and about 70% of males are having some subjective issues with erections at the age of 70 years.[2] Erection is a neurovascular event in which a key mediator is nitric oxide (NO). It has been shown that there is reduced NO bioactivity in ED.[3] Oral phosphodiesterase-5 inhibitors (PDE-5 inhibitors), such as sildenafil and Tadalafil, are usually the first-line treatment of erectile dysfunction. They are effective in a wide range of etiologies including cardiovascular disease, diabetes, and hypogonadism. They act by decreasing the degradation of cyclic GMP via phosphodiesterase inhibition, which increases the relaxation of cavernosal smooth muscle and cavernosal arterial blood flow. It is important to note that PDE-5 inhibitors do not initiate the erectile response. Sexual stimulation is required to release nitric oxide from the vascular endothelium and penile nerve endings to commence the erectile process. PDE-5 inhibitors are highly effective and have an overall success rate of up to 76%.[4]
As L-arginine is a natural precursor of NO and its good availability is understood to have positive effect on NO production. Data regarding the pattern of use of L-arginine for sexual problems, which is considered one of the more widely used alternatives or adjuncts to regular drugs used in the patients of ED.[5] Aim of Work To evaluate the role of L-arginine monotherapy versus Tadalafil monotherapy versus their combination for the treatment of erectile dysfunction .
Patients and methods This clinical prospective study will be carried out on patients attending urology clinic in Fayoum University Hospital with ED
Sample size :
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •• Naive ( not previously treated) male patient with mild to moderate ED according to SHIM Questionnaire.
排除标准
- •● Kidney disease or liver failure
- •Coronary heart disease
- •Peyronie's disease
- •Neurological disease that may related to ED
研究组 & 干预措施
Group A
was given daily 3 g(three divided doses) oral tablets of L-arginine for eight weeks
干预措施: L-Arginine (Drug)
Group B
was given daily 5 mg oral tablets of Tadalafil for eight weeks.
干预措施: Tadalafil 5 mg (Drug)
Group C
was given daily 3 g oral tablets of L-arginine and 5 mg oral tablets of Tadalafil for eight weeks.
干预措施: L-Arginine (Drug)
Group C
was given daily 3 g oral tablets of L-arginine and 5 mg oral tablets of Tadalafil for eight weeks.
干预措施: Tadalafil 5 mg (Drug)
结局指标
主要结局
SHIM questionnaire
时间窗: 8 weeks of treatment
The SHIM (Sexual Health Inventory for Men) questionnaire is a commonly used tool for assessing erectile dysfunction (ED) in men. It is a brief, self-administered questionnaire that typically consists of five questions, with answers scored on a scale to help determine the severity of erectile dysfunction. The SHIM is widely used in both clinical practice and research to assess sexual health and function. Here are the key elements of the SHIM: Frequency of sexual activity (often using a scale from "almost never or never" to "almost always or always"). Confidence in maintaining an erection (again, on a similar scale). Ability to achieve an erection. Erection firmness (whether the erection is hard enough for penetration). Satisfaction with the firmness of the erection. The scores are typically aggregated into one overall score, and depending on the score, it classifies the degree of erectile dysfunction: 25-22: No erectile dysfunction 21-17: Mild erectile dysfunction 16-12: Mild to mod
次要结局
- testosterone level(8 weeks of treatment)
- Shear Wave Elastography(8 weeks of treatment)
研究者
Mohamed Mahmoud Dogha
lecturer of urology
Fayoum University Hospital