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

NCT06303661 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-29

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Centro de Atenção ao Assoalho Pélvico

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303661 on ClinicalTrials.gov