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ENROLLING BY INVITATION
NCT07128420
PHASE1

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

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-09-01

Completion Date

2027-09

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Ottawa Hospital

Ottawa, Ontario, Canada