Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation: Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- IELT
研究概览
简要总结
This randomized controlled cross-over study aims to evaluate the effect and safety of glans penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare with placebo .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •occurrence of ejaculation in patients with lifelong premature ejaculation (LL PE) within 1 minute form vaginal penetration in all or almost all occasions starting from the first sexual experience, and within 3 minutes in patients with acquired premature ejaculation (A PE), along with inability to delay ejaculation on all or nearly all vaginal penetrations, with negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy
排除标准
- •Erectile dysfunction
- •Hypo or hyperthyroidism
- •Hypogonadism
- •Hyperprolactinemia
- •Drug abuse
- •Psychiatric disorders or related medications
研究组 & 干预措施
group 1
15 patients They will receive a topical anesthetic agent for 30 minutes (Emla cream; lidocaine 25 mg, prilocaine 25 mg, Astra Xeneca, Mississauga, Canada) followed by injection of two prefilled 1 ml syringes with 30 G needle of hyaluronic acid (HA; Teosyal® PureSense Global Action, Teoxane Laboratories, Geneva, Switzerland). After 18 months from the HA injection, cross-over to placebo arm will be done.
干预措施: Hyaluronic Acid (Drug)
group 2
They receive by the same method 2 ml saline as a placebo. After one month of the injection, cross-over to HA arm will be done.
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
IELT
时间窗: Change from baseline after one month
Intra-vaginal Ejaculation Latency Time
AIPE
时间窗: Change from baseline after one month
Arabic index of premature ejaculation
次要结局
- IELT(Change from baseline after three, six and nine months)
研究者
Mohamed Wael Ragab
Clinical demonstrator
Cairo University