A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- BOTOX efficacy
研究概览
简要总结
This study aims to evaluate the clinical efficacy of intracavernosal treatment with onabotulinumtoxinA (Botox) in 114 men aged 30 years or older with erectile dysfunction who have not responded to first-line oral pharmacological treatment.
For this purpose, the effects of onabotulinumtoxinA are compared with those of a placebo consisting of an intracavernosal injection of physiological saline. The study is patient-blinded.
Participants in the experimental group receive 100 U of onabotulinumtoxinA diluted in 1 mL of physiological saline, while participants in the control group receive 1 mL of physiological saline.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with erectile dysfunction (ED) with an inadequate response to phosphodiesterase type 5 inhibitors (PDE5 inhibitors) or to intracavernosal injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤12).
- •Patients aged 30 years or older.
- •Patients who have provided informed consent to participate in the study.
- •Patients who, in the investigator's opinion, are able to comply with all clinical trial requirements.
- •Patients who agree to attend follow-up visits and undergo the required assessments.
排除标准
- •Severe infections or diseases, or hepatic, renal, or bone marrow insufficiency, that, in the investigator's opinion, contraindicate participation in the study.
- •Known hypersensitivity to onabotulinumtoxinA (BoNT-A).
- •Patients who do not consent to participate in the study.
- •Patients younger than 30 years.
- •Patients who underwent robotic radical prostatectomy less than 6 months prior to study enrollment.
- •Patients with a known history of neurogenic injury.
- •Patients with a history of radiation therapy.
- •Patients with a known psychiatric disorder.
- •Patients with anatomical abnormalities of the penis.
- •Patients who do not agree to, or are unable to commit to, attending the scheduled follow-up visits.
研究组 & 干预措施
Placebo (Normal Saline)
Participants receive an intracavernosal injection of 1 mL of physiological saline as placebo.
干预措施: Saline (0.9% NaCl) (Drug)
OnabotulinumtoxinA (Botox) 100 U
Participants receive an intracavernosal injection of 100 U of onabotulinumtoxinA (Botox) diluted in 1 mL of physiological saline.
干预措施: OnabotulinumtoxinA (Botox ®) Injections (Drug)
结局指标
主要结局
BOTOX efficacy
时间窗: 6 months
Check if intracavernosal injections of onabotulinum toxin A improve erectile dysfunction in refractory patients to oral medication using questionnaires.
次要结局
未报告次要终点