2024-514518-10-00招募中2 期
Randomised double-blind clinical trial of Onabotulinumtoxin A injection into the corpora cavernosa in patients with erectile dysfunction refractory to treatment with phosphodiesterase-5 inhibitors
Clinica Universidad De Navarra1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Subjective perception of rigidity
研究概览
简要总结
To test the therapeutic efficacy of intracavernous injections (ICI) of Onabotulinumtoxin A (BoNT-A) in the treatment of erectile dysfunction (ED)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with ED with insufficient response to IPDE5 or intracavernous injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤ 12).
- •The patient is over 30 years old
- •The patient, or his or her representative, has given consent to participate in the study.
- •The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- •Patient must commit to attending follow-up appointments and undergoing the appropriate tests.
排除标准
- •Patients who do not accept informed consent
- •Patients who do not accept or cannot commit to attending the follow-up sessions.
- •Patients under 30 years of age.
- •Known hypersensitivity to BoNT-A
- •Serious infections or diseases or hepatic, renal or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria.
- •Patients with robotic radical prostatectomy less than 6 months ago
- •Patients with a history of known neurogenic damage
- •Patients with a history of radiotherapy treatment
- •Patients with known psychiatric disorder
- •Patients with anatomical abnormalities in the penis.
结局指标
主要结局
Subjective perception of rigidity
Subjective perception of rigidity
次要结局
未报告次要终点
研究者
José Enrique Robles García
Scientific
Clinica Universidad De Navarra
研究点 (1)
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