Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303661
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-12-04
Brief Title:
Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronies Disease
Sponsor:
Centro de Atenção ao Assoalho Pélvico
Organization:
Centro de Atenção ao Assoalho Pélvico
Study Overview
Official Title:
Non-ablative Radiofrequency and Low-intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronies Disease Case Series
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Peyronies disease The main questions 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 Peyronies 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 participants 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 theyll be given are of monopolar non-ablative radiofrequency associated with low-intensity shock wave therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None