protocolSection identificationModule nctId: NCT06303661, orgStudyIdInfo id: 74001323.3.0000.5544, briefTitle: Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Centro de Atenção ao Assoalho Pélvico, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Peyronie Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Combination of two therapies with conservative devices is proposed., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Non-ablative Radiofrequency, interventions name: Low-intensity Shock Wave Therapy, outcomesModule primaryOutcomes measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function., primaryOutcomes measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain., primaryOutcomes measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection., secondaryOutcomes measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression., secondaryOutcomes measure: It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Atenção ao Assoalho Pelvico, status: RECRUITING, city: Salvador, state: Ba, zip: 40.290-000, country: Brazil, contacts name: Patricia V Lordelo, Phd, role: CONTACT, phone: +5571988592400, email: pvslordelo@hotmail.com, contacts name: Carlos Mamede, Phd, role: SUB_INVESTIGATOR, contacts name: Patricia V Lordelo, Phd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -12.97111, lon: -38.51083, hasResults: False