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临床试验/NCT04756206
NCT04756206已完成2 期

Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
NIH chronic prostatitis symptom index in study population

研究概览

简要总结

this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3.

详细描述

Nonbacterial prostatitis refers to a condition that affects patients who present with symptoms of prostatitis without a positive culture for urine or expressed prostate secretions (EPS). With time our understanding of prostatitis was evolved to include a different clinical phenotype with a variety of voiding presentation and symptomatology rather than just inflammation and infection. The two main clinical presentations of prostatitis include pelvic pain and LUTS.

The National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) proposed the first classification of prostatitis into 4 categories in 1995 that was later published in 1998. Bacterial prostatitis represented category I and III while nonbacterial prostatitis including chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was categorized as category III that was further subdivided into class IIIa (inflammatory CPPS) and b (non-inflammatory CPPS). Category IV encompasses asymptomatic inflammatory prostatitis.

Shoskes et al, mentioned that inflammation and the upregulation of cytokine expression and release in the prostate secondary to an inflammatory process led to the presenting symptoms in such a condition. The recently introduced UPOINT phenotype categorization of CP/CPPS (Urinary, Psychosocial, Organ-specific, Infection, Neurological/Systemic, Tenderness of the skeletal muscles). This categorization shows up to 60% of men have at least prostate organ associated symptoms.

The prostate lies under the hormonal control of dihydrotestosterone (DHT); thus 5 alpha-reductase inhibitors (5ARIs) might be beneficial in the treatment of prostatitis. Dutasteride is a 5α-reductase inhibitor, and hence is a type of anti-androgen. It works by decreasing the production of (DHT) in certain parts of the body like the prostate gland. It inhibits all three forms of 5α-reductase and can decrease DHT levels in the blood by up to 98%.

5ARIs have been previously evaluated on a narrow scale in the management of prostatitis with promising results of safety and efficacy.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months

排除标准

  • Patients with bacterial prostatitis
  • documented site of infection along the urinary tract,
  • urinary bladder tumors
  • prostate cancer
  • previous history of pelvic radiation or chemotherapy were excluded from our study.

研究组 & 干预措施

Dutasteride

Active Comparator

Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.

干预措施: Dutasteride 0.5 mg (Drug)

Placebo

Placebo Comparator

same form and color of Dutasteride tablet was given at the same regimen to act as a placebo

干预措施: Placebo (Drug)

结局指标

主要结局

NIH chronic prostatitis symptom index in study population

时间窗: assessment was made at 3 months after intervention

scoring system aims to evaluate chronic prostatitis and severity of symptoms

次要结局

  • change in libido in study population(3 months after medication)
  • Gastritis in study population(3 months after medication)
  • Dizziness in study population(3 months after medication)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maher Gamil Ahmed Higazy

Assistant lecturer

Ain Shams University

研究点 (1)

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