A Randomized Double-Blind Placebo-Controlled Trial of Dual-Site Botulinum Toxin Type A Injection Into the Bulbospongiosus Muscle and Glans Penis for Lifelong Premature Ejaculation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- intravaginal ejaculatory latency time (IELT )
研究概览
简要总结
Premature ejaculation is a common sexual condition that can cause distress for men and their partners. Different treatments are available, but some men do not respond well to standard therapies.
This study was designed to evaluate whether injecting botulinum toxin type A into two areas of the penis and surrounding muscles can help delay ejaculation in men with lifelong premature ejaculation. Participants were randomly assigned to receive either botulinum toxin injections or placebo injections.
The study evaluated ejaculation time, sexual satisfaction, and quality of life over a follow-up period of six months. Safety and possible side effects were also monitored during the study.
详细描述
Lifelong premature ejaculation is a common male sexual disorder characterized by ejaculation that occurs with minimal sexual stimulation and causes personal distress. Although several pharmacological and behavioral treatment options are available, a subset of patients does not achieve satisfactory results or experiences side effects.
Botulinum toxin type A has neuromodulatory properties that may influence ejaculatory reflex pathways. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of dual-site botulinum toxin type A injection in men with lifelong premature ejaculation.
Eligible participants were randomly assigned to receive either botulinum toxin type A or placebo injections. Injections were administered into the bulbospongiosus muscle and the glans penis under standardized conditions. Participants were followed for six months after treatment.
The primary outcome measure was intravaginal ejaculatory latency time. Secondary outcomes included patient-reported measures of sexual satisfaction, perceived control over ejaculation, and quality of life. Safety outcomes and adverse events were monitored throughout the study period
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
participants ,care providers ,investigators ,and outcome assessors were blinded to treatment assignment
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
- •male participants aged 20 years or older . diagnosis with lifelong premature ejaculation, in a stable heterosexual relationship for at least 6 months prior to enrollment, engaged in vaginal intercourse during the study period, willing and able to provide written informed consent -
排除标准
- •presence of acquired premature ejaculation, history of erectile dysfunction require treatment , current use of medication known to affect ejaculation or sexual function ,previous treatment with botulinum toxin for sexual dysfunction ,history of sever neurological or psychatricor endocrine disorders affection sexual function , active genital infection or penile anatomical abnormalities , hypersensitivity to botulinum toxin ,mythenia gravis
研究组 & 干预措施
BOTULINUM TOXIN TYPE A
Botulinum toxin type A was injected into the bulbospongiosus muscle and glans penis according to a standerdized protocol. this intervention was designed to modulate neuromuscular activity involved in the ejaculatory reflex
干预措施: BoNT-A (Drug)
placebo
placebo injection were administered into the bulbospongiosus muscle and the glans penis using the same procedure and volume as the experimental intervention
干预措施: Placebo injection (normal saline) (Drug)
结局指标
主要结局
intravaginal ejaculatory latency time (IELT )
时间窗: Baseline to 6 months after intervention
intravaginal ejaculatory latency time was defined as the time from vaginal penetrationto ejaculation . measured by stopwatch in minutes or seconds
Intravaginal Ejaculatory Latency Time ( IELT)
时间窗: Baseline to 6 months after intervention
(IELT) was defined as the time from vaginal penetration to ejaculation, measured in minutes using a stopwatch
次要结局
- sexual satisfaction(Baseline to 6 months after intervention)
研究者
HAITHAM ABDALLA
MD Urology and Andrology
Al Mouwasat Hospital