Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronies Disease Case Series

What this Trial Is About

Researchers are evaluating the safety and clinical response of a combined treatment using non-ablative radiofrequency and low-intensity shock wave therapy in men with Peyronies disease. This one-arm clinical trial aims to determine if this treatment is safe and whether it improves symptoms such as sexual function, pain, and penile erection. The study also explores the impact of this therapy on quality of life and psycho-emotional aspects like anxiety and depression. The treatment involves applying monopolar non-ablative radiofrequency and electromagnetic low-intensity shock wave therapy directly to the fibrotic plaque on the penis. Treatments are given 2 to 5 times a week, depending on the patients availability, for a total of 24 sessions. Specific devices are used to deliver radiofrequency at a controlled temperature and shock waves with set energy and frequency parameters to the affected area. Participants will complete five validated questionnaires and undergo physical assessments including palpation and ultrasound of the fibrotic plaque. Evaluations occur before treatment, after treatment, and one month post-treatment. Satisfaction and symptom changes are measured regularly during treatment. Telephone follow-ups at 3, 6, 9, and 12 months after treatment assess long-term effects. Researchers will monitor sexual function, pain, erection quality, and psychosocial factors throughout the study.

Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease