Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease: Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function.
研究概览
简要总结
The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question[s] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical complaint related to Peyronie's disease;
- •At any stage of the disease (acute or chronic).
排除标准
- •Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant;
- •Metallic implants over or under the area to be treated.
研究组 & 干预措施
RF and SWT
The treatment will be carried out through the application of monopolar non-ablative radiofrequency (IBRAMED, Amparo, São Paulo, Brazil - model Neartek) associated with electromagnetic low-intensity shock wave therapy (IBRAMED, Amparo, São Paulo, Brazil - model THOOR) on the fibrotic plaque in the penis, 2 to 5 times a week, according to the patient's availability, totaling 24 sessions.
干预措施: Non-ablative Radiofrequency (Device)
RF and SWT
The treatment will be carried out through the application of monopolar non-ablative radiofrequency (IBRAMED, Amparo, São Paulo, Brazil - model Neartek) associated with electromagnetic low-intensity shock wave therapy (IBRAMED, Amparo, São Paulo, Brazil - model THOOR) on the fibrotic plaque in the penis, 2 to 5 times a week, according to the patient's availability, totaling 24 sessions.
干预措施: Low-intensity Shock Wave Therapy (Device)
结局指标
主要结局
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function.
时间窗: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
It will be measured by the questionnaire International Index of Erectile Dysfunction (IIEF-5). Lower values represent worse sexual function and are categorized as follows: 5-7 points represents severe erectile dysfunction, 8-11 points represents moderate erectile dysfunction, 12-16 represents mild to moderate erectile dysfunction, 17 -21 represents mild erectile dysfunction and 22-25 means no erectile dysfunction.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain.
时间窗: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
The level of pain will be assess by the question three questions of Peyronie's Disease Questionnaire (PDQ). Each of the three questions score from 0 to 10, so the total range will be from 0 to 30. The lower the score, the less pain the patient feels.
It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection.
时间窗: From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.
The quality of penile erection will be measured by the Quality of Erection Questionnaire. The final score can vary between 0 and 100 points, with the higher the score, the better the quality of the erection.
次要结局
- It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression.(From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.)
- It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression.(From enrollment to the end of treatment till 8 weeks, then at 1, 3, 6, 9 and 12 months.)