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

Centro de Atenção ao Assoalho Pélvico

Status: Enrolling

Conditions: Peyronie Disease

Treatments: Device: Non-ablative Radiofrequency; Device: Low-intensity Shock Wave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06303661

74001323.3.0000.5544

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical complaint related to Peyronie's disease;
• At any stage of the disease (acute or chronic).

Exclusion criteria

• Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant;
• Metallic implants over or under the area to be treated.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

RF and SWT

Experimental group

Description:

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.

Treatment:

Device: Low-intensity Shock Wave Therapy

Device: Non-ablative Radiofrequency