Clinical Trials Logo
  1. Home
  2. Peyronie Disease
  3. NCT06303661

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

Peyronie Disease Clinical Trial

Official title:
Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease: Case Series

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06303661
Study type Interventional
Source Centro de Atenção ao Assoalho Pélvico
Contact Carlos Mamede, doctorade
Phone 55 71 996673967
Email carlosmamede@bahiana.edu.br
Status Recruiting
Phase N/A
Start date January 8, 2024
Completion date June 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT03774264 - Treatment Response to Xiaflex for Men With Peyronie's Disease
Recruiting NCT05777031 - Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease Phase 4
Active, not recruiting NCT05871177 - Safety and Efficacy of Intralesional HiLow Hyaluronic Acid in the Treatment of Peyronie's Disease (PD) N/A
Recruiting NCT05768867 - French Translation and Validation of the PEYronie's Disease QUESTionnaire
Recruiting NCT04512287 - PRP for Treatment of Peyronie's Disease Phase 2
Withdrawn NCT05646602 - Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction N/A
Recruiting NCT03530540 - Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease. N/A
Completed NCT04052217 - Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse N/A
Recruiting NCT06065436 - Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease N/A
Recruiting NCT05316714 - Novel Nanofat Regenerative Surgical Technique for Peyronies' Disease Treatment N/A
Completed NCT04370652 - Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum
Active, not recruiting NCT05480683 - Pelvic CT With Agatston Calcium Score for Peyronie Disease N/A
Recruiting NCT04821115 - Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease N/A