Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients. A Randomized Single-blind Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Arabic Index of Premature Ejaculation Scores
研究概览
简要总结
This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
详细描述
This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. All medications were applied on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse. Patients were evaluated with Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments.
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
- Single (Investigator)
盲法说明
Patients were randomized evenly categorized into two treatment groups. Patient's distribution in the two groups was according to randomized encoded ballots, and they were unobservant of the type of the topical medications used.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of lifelong premature ejaculation
排除标准
- •renal or liver diseases,
- •diabetes mellitus,
- •thyroid diseases,
- •chronic prostatitis,
- •neurological diseases
- •allergic reactions to local anesthetics or alcohols.
- •erectil dysfunction
研究组 & 干预措施
lidocaine 5% spray
Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system).
干预措施: Lidocaine 5% spray (Drug)
Placebo
Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks (One to two applications (1-2 ml) of alcohol 70% sprays).
干预措施: Placebo (Other)
结局指标
主要结局
Arabic Index of Premature Ejaculation Scores
时间窗: 0-8 weeks after treatment
Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).
Intravaginal ejaculatory latency times
时间窗: 0-8 weeks after treatment
Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.
次要结局
未报告次要终点
研究者
Mohammed Abu El-Hamd
Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.
Sohag University