Extracorporeal Shockwave Therapy in the Treatment of Peyronie's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Erectile function
研究概览
简要总结
Investigation of the effectiveness of extracorporeal shock wave therapy in the treatment of Peyronie's disease.
详细描述
The study is designed as a single-center, prospective clinical trial. Participants will be selected from among patients who present to the clinic and are diagnosed with stable stage Peyronie's disease. All participants who meet the eligibility criteria and provide written consent will undergo a standard Extracorporeal Shockwave Therapy protocol. All participants will be evaluated before and after treatment using the International Erectile Function Index-5 and the Quality of Life Questionnaire short form. The results will be statistically analyzed and interpreted.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male individuals aged 18-65 years.
- •Having been diagnosed with Peyronie's Disease that has been stable (without increasing pain and curvature) for at least 6 months.
- •Presence of palpable penile plaque.
排除标准
- •Acute inflammatory stage (painful, progressive)
- •Having previously undergone surgery, needle therapy (e.g., Xiaflex), or Extracorporeal Shockwave Therapy for peyronie's disease.
- •Uncontrolled diabetes, severe coagulopathy, or receiving anticoagulant therapy.
- •History of penile cancer.
- •Severe erectile dysfunction.
- •Patients who are considered unable to comply with the study protocol or who cannot attend follow-up visits.
研究组 & 干预措施
control
patients receiving normal routine pharmacological treatment without any special intervention
干预措施: control (Other)
Extracorporeal Shockwave Therapy
Patients receiving Extracorporeal Shockwave Therapy treatment
干预措施: Extracorporeal Shockwave Therapy (Other)
结局指标
主要结局
Erectile function
时间窗: 5 weeks
The International Index of Erectile Function is recorded as a total score. It is measured by a self-reported questionnaire with 5 domains, with each domain consisting of 5 options. The score ranges from 5 to 25, with 5 being the lowest score (severe erectile dysfunction) and 25 being the best score (maximal erection)
Short Form-36
时间窗: 5 weeks
Short Form-36 Health Survey is a non-disease-specific instrument consisting of 36 items used to assess health-related quality of life. It includes eight subscales covering physical and mental health domains. Each subscale is scored from 0 to 100, with higher scores indicating better health status, while one item assessing health change is not included in subscale scoring. A high score indicates a higher quality of life.
次要结局
未报告次要终点
研究者
Doç.Dr.Ömer Şevgin
Assoc.Prof.Dr.
Uskudar University