A Randomized, Controlled Study of the Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- IELT FOLD INCREASE
研究概览
简要总结
The present study included 57 patients ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ≥11.
Subjects were randomized to an experimental group that used the device with exercise programme (n=18) a first control group that only used the exercise programme (n=17) and a wait-list control group (n=22).
As a main outcome measure used stopwatch-measured average IELT, Premature Ejaculation Profile (PEP), and the Golombok-Rust Inventory of Sexual Satisfaction (GRISS).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must be heterosexual males
- •To be in a stable monogamous, sexual relationship with a female partner for at least 6 months,
- •Must score = 11 in the Premature Ejaculation Diagnostic Tool (PEDT).
- •Must have a self-estimated average intravaginal ejaculatory latency time (IELT) of <2 min. -Must be in good general health with no clinically significant abnormalities as determined by medical history and clinical lab results.
排除标准
- •To suffer an alteration or mental disorder according to the criteria of the DSM-IV.
- •History of alcohol abuse and dependence.
- •Do not to consume medication, drugs of recreative use or alcohol (except for caffeine or nicotine/tobacco).
研究组 & 干预措施
device
干预措施: Exercise Programme +device+ lubricant (Device)
behavioral
干预措施: Exercise Programme + lubricant (Behavioral)
waiting list
结局指标
主要结局
IELT FOLD INCREASE
时间窗: 7 weeks
fold changes are defined directly in terms of ratios.If the initial value is A and the final value B, the fold change is defined as B/A
次要结局
- Premature Ejaculation Profile (PEP)(7 weeks)