EUCTR2022-002985-34-ES招募中1 期
EFFECTIVENESS AND SAFETY OF COMBINED AUTOLOGOUS PLATELET RICHPLASMA AND FOCAL SHOCKWAVE THERAPY FOR THE TREATMENT OFERECTILE DYSFUNCTIO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Men over 18 years old.
- •2. Erectile dysfunction present for more than 3 months in more than 50% of coitus.
- •3. Baseline score of the IIEF-EF questionnaire between 11 and 21.
- •4. Stable heterosexual relationship of at least 6 months.
- •5.Commitment to have at least 3 vaginal intercourse per month after treatment ends.
- •6.Commitment not to use other natural, oral or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
- •7.Patient who agrees to enter the study voluntarily by signing an informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •1. Score of 4 on the EHS scale.
- •2. Patients with INR greater than 3.
- •3. Patients with sickle cell anemia.
- •4. Patients with clinical suspicion of hypogonadism (ADAM positive).
- •5. Acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
- •6. Active bladder, prostate or colon cancer.
- •7. Radical prostatectomy or other radical pelvic surgery.
- •8. History of pelvic radiotherapy.
- •9. Spinal cord injury or other neurological disease associated with ED.
- •10. Penile anatomical dysfunction, penile implant.
- •11. Platelet diseases or coagulation disorders.
- •12. Treatment with oral anticoagulants.
- •13. Platelet count outside the normal range (150 to 400 × 109/L).
- •14. Patients with active infections or lesions of the penis or pubic area.
- •15. Patients with erectile dysfunction secondary to drug treatment (antiandrogenic therapy, Alpha blockers for BPH, use of corticosteroids, antiparkinsonians, antipsychotics).
- •16. Patients with erectile dysfunction of psychological origin.
- •17. Abuse of psychoactive substances (including alcohol).
- •18. Cognitive or physical illness that prevents you from participating in the study, self-completing the questionnaires or attending therapies and controls.
- •19. Inability to attend therapies and controls.
研究者
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