The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Premature Ejaculation Diagnostic Tool (Total Score)
研究概览
简要总结
The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week
排除标准
- •Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.
研究组 & 干预措施
Dapoxetine 30 mg
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
干预措施: dapoxetine 30 mg on demand (Drug)
Moderate Running
Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (Minimally active category)
干预措施: physical activity (Behavioral)
Sham-controlled
Patients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category)
干预措施: physical activity (Behavioral)
结局指标
主要结局
Premature Ejaculation Diagnostic Tool (Total Score)
时间窗: Baseline and 30 Days
Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
Intravaginal Ejaculatory Latency Time
时间窗: Baseline and 30 Days
Duration determined by the sexual partner with stopwatch method, and \<1 minute was considered as PE. (minimum/maximum scores were not possible)
次要结局
未报告次要终点
研究者
Muhammet Fatih Kilinc
M.D.
Ankara Training and Research Hospital