Actively Recruiting
Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease
Led by Ottawa Hospital Research Institute · Updated on 2025-09-17
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peyronie's Disease (PD) is a fibrosing 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. At present, available medical and surgical treatment modalities for PD have limitations. Intralesional collagenase clostridium histolyticum (CCh) is approved for the reduction of penile curvature in PD, however, its use is restricted to the United States market. Other medical therapies including intralesional verapamil and interferon injections have inconsistent and modest effects while, invasive surgical management with plication or grafting can result in erectile dysfunction, penile length shortening, penile sensory changes, and harvest site complications. Fractional CO2 Laser Therapy is an extra-dermal (applied to the surface of the skin) and non-invasive treatment that involves the use of lasers to destroy and reduce abnormal collagen in scarred tissue. Most recently, it has been used in a pilot clinical trial investigating its use in the management of PD. All men in this study safely experienced reduction in their penile curvature. This will be a phase 1 clinical trial evaluating the safety and feasibility of using a fractional CO2 laser 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 laser therapy sessions at 6 week intervals and will have a short and long-term follow-up of 24 and 52 weeks, respectively.
CONDITIONS
Official Title
Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 18 years or older
- For heterosexual men, must be in a stable relationship with a female partner for at least 3 months and willing to have vaginal intercourse to complete the PD Questionnaire
- Diagnosis of Peyronie's Disease for at least 12 months with stable disease (no change in penile curve for at least 6 months and no pain)
- Penile curvature between 30 a and 90 a in the dorsal, lateral, or dorsal/lateral plane, with a single plane of maximal curvature for evaluation
- Signed informed consent and authorization to disclose protected information
- Ability to read, complete, and understand study questionnaires in English
You will not qualify if you...
- Penile curvature less than 30 a or greater than 90 a
- Conditions affecting the penis such as chordee, thrombosis of the dorsal penile artery, masses, infections, ventral curvature, or active sexually transmitted disease
- Inability to achieve a sufficient erection (8/10) to measure penile deformity after medication
- Presence of calcified plaque shown by ultrasound that prevents laser treatment
- Isolated hourglass deformity of the penis without curvature
- Previous or planned treatments for Peyronie's Disease within specified timeframes, including surgery, medications, injections, shock wave therapy, or mechanical devices
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9
Actively Recruiting
Research Team
A
Amanda Ross
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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