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

NCT ID: NCT06303661

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Peyronie Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-ablative Radiofrequency

Intervention Type: DEVICE

There are two electrodes: one active, which will be used on the penis, using a non-lubricated condom from the Blowtex brand, using pharmaceutical glycerin to emit radiofrequency inside and outside the condom, and another electrode, dispersive, wrapped in PVC-type plastic film, coupled to the region of the patient's penis where there is no fibrotic plaque, which will act as earth and the temperature to be used in the treatment will be 38°C. When the desired heating is reached, the device maintains the temperature and thus the radiofrequency application will be maintained for 2 minutes.

Low-intensity Shock Wave Therapy

Intervention Type: DEVICE

The equipment's applicator is covered with transparent PVC film and non-alcoholic gel is used as a coupling medium between the applicator and the penis. The following parameters are used: frequency of 10Hz, energy of 120mJ and 2,000 shots in the fibrotic plaque.

Interventions

Non-ablative Radiofrequency

There are two electrodes: one active, which will be used on the penis, using a non-lubricated condom from the Blowtex brand, using pharmaceutical glycerin to emit radiofrequency inside and outside the condom, and another electrode, dispersive, wrapped in PVC-type plastic film, coupled to the region of the patient's penis where there is no fibrotic plaque, which will act as earth and the temperature to be used in the treatment will be 38°C. When the desired heating is reached, the device maintains the temperature and thus the radiofrequency application will be maintained for 2 minutes.

Intervention Type: DEVICE

Low-intensity Shock Wave Therapy

The equipment's applicator is covered with transparent PVC film and non-alcoholic gel is used as a coupling medium between the applicator and the penis. The following parameters are used: frequency of 10Hz, energy of 120mJ and 2,000 shots in the fibrotic plaque.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centro de Atenção ao Assoalho Pélvico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Carlos Mamede, doctorade

Role: CONTACT

carlosmamede@bahiana.edu.br

55 71 996673967

Patrícia Lordelo, post-PhD

Role: CONTACT

pvslordelo@hotmail.com

55 71 996592400

Facility Contacts

Patricia V Lordelo, Phd

Role: primary

pvslordelo@hotmail.com

+5571988592400

Other Identifiers

74001323.3.0000.5544

Identifier Type: -

Identifier Source: org_study_id