Peyronie's Disease (PD) is a disorder of the penis where scar tissue (composed of excessive and disorganized collagen) known as a "plaque," forms along the shaft of the penis. This plaque can lead to permanent penile deformity (curvature, narrowing, indentation, hinging), loss of penile length, erectile dysfunction, and pain during intercourse. Research has shown PD to negatively impact the quality of life and cause significant psychosocial distress for many men. This study proposes the use of microneedle treatment of chronic phase PD. Microneedling is a minimally invasive technique that creates tiny injuries in scarred tissues, which encourages a controlled healing process. This will be a pilot clinical trial evaluating the safety and feasibility of using microneedling treatment in the management of chronic phase PD. Enrolled study participants will undergo an initial clinical assessment of their PD which involves penile measurements at flaccid and erect states, a curvature assessment with duplex ultrasound, and will be asked to complete the International Index of Erectile Function Questionnaire (IIEF-5), and Peyronie's Disease Questionnaire (PDQ). They will then undergo 3-4 treatment sessions at 6-8 week intervals. This will then be followed by a short and long-term follow-up at 24 and 52-54 weeks, respectively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Enrolled study participants will receive 3-4 treatments of microneedling to the affected area. Study participants will microneedling (Fusion Tip Potenza Fractional Radiofrequency Microneedle Electrosurgical Unit, Jeisys Medical Inc, Seoul, KR) at a depth of 2.0 to 2.75mm.
The Ottawa Hospital
Ottawa, Ontario, Canada
Safety
Given that this is a pilot study, safety is a critical outcome alongside feasibility and efficacy. Adverse events (AEs) and serious adverse events (SAEs) related to microneedling will be collected, documented, and analyzed to evaluate the safety profile of the intervention. AEs will be assessed at every treatment and follow-up visit through direct questioning, physical examinations, and spontaneous participant reports. Investigators will use a standardized adverse event log to capture the nature, severity, duration, frequency, and outcome of all events. The incidence of AEs and SAEs will be summarized descriptively using counts and percentages. Events will be categorized by severity (mild, moderate, severe), expectedness (anticipated vs. unanticipated), and relationship to the intervention (definitely, probably, possibly, unlikely, unrelated).
Time frame: 52 weeks
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