NCT07128420

Microneedle Treatment of Chronic Phase Peyronie's Disease: A Pilot Clinical Trial

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peyronie's Disease

Interventions

Type	Name	Description
DEVICE	Application of 3 sessions of microneedle therapy	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study