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

Last updated: May 27, 2024
Sponsor: Centro de Atenção ao Assoalho Pélvico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peyronie's Disease

Treatment

Low-intensity Shock Wave Therapy

Non-ablative Radiofrequency

Clinical Study ID

NCT06303661
74001323.3.0000.5544
  • Ages 18-80
  • Male

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical complaint related to Peyronie's disease;

  • At any stage of the disease (acute or chronic).

Exclusion

Exclusion Criteria:

  • Users of a pacemaker, cardiac defibrillator implant or any other electromagneticimplant;

  • Metallic implants over or under the area to be treated.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Low-intensity Shock Wave Therapy
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Centro de Atenção ao Assoalho Pelvico

    Salvador, Ba 40.290-000
    Brazil

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.