Fractional CO2 laser for chronic Peyronie's disease

Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease

This will try fractional CO2 laser to reduce plaque-related penile curvature and symptoms in men with chronic, stable Peyronie's disease.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT07177833 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study at The Ottawa Hospital compares fractional CO2 laser treatment to a sham (no treatment) control in men with chronic Peyronie's disease. Eligible participants have had PD for at least 12 months with a stable single-plane penile curvature of 30°–90° and are able to complete validated PD questionnaires in English. Treatment is delivered to the penile plaque with follow-up visits to measure curvature, collect patient-reported outcomes, and monitor safety. The primary focus of this early-phase trial is safety and tolerability, with preliminary signals of symptom or curvature change recorded.

Who should consider this trial

Good fit: Men aged 18 or older with chronic (≥12 months), stable Peyronie's disease, a single-plane penile curvature of 30°–90°, and the ability to complete English questionnaires are the intended participants.

Not a fit: Men with curvature under 30° or over 90°, recent/unstable disease, or other penile abnormalities such as chordee or thrombosis are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the laser could reduce plaque and curvature and offer a less invasive option to improve sexual function and quality of life.

How similar studies have performed: Using fractional CO2 laser for Peyronie's disease is relatively novel with limited clinical data, although laser therapies have been explored in small or early-phase studies.

Eligibility criteria

Inclusion Criteria:

1. Men 18 or older. For heterosexual men it is required they be in a stable relationship with a female spouse/partner for at least 3 months and willing to have vaginal intercourse for purposes of properly filling out the validated PD Questionnaire.
2. Diagnosis of PD for at least 12 months with evidence of stable disease as determined by the investigator (i.e. no change in penile curve for at least 6 months and absence of pain).
3. Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane (must be possible to delineate the single plane of maximal curvature for evaluation)
4. Signed informed REB-approved consent agreement; signed authorization form to allow disclosure of protected information.
5. Ability to read, complete, and understand the various rating instruments in English.

Exclusion Criteria:

1. Penile curvature of \<30º or \>90º
2. Any conditions affecting the penis such as a chordee in the presence or absence of hypospadias; thrombosis of the dorsal penile artery; infiltration by a benign or malignant mass or an infectious agent; ventral curvature from any cause; presence of an active sexually transmitted disease.
3. Failure to achieve a sufficient 8/10 erection (after prostaglandin E or Trimix administration), in the opinion of the investigator, to accurately measure the penile deformity.
4. Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with Fractional CO2 Laser
5. Isolated hourglass deformity of the penis without curvature
6. Treatment or plans to undergo treatment for PD, including but not limited to any previous surgery, oral/topical agents within 3 months, intralesional medical therapies within 3 months, extracorporeal shock wave therapy within 6 months, or use of mechanical devices within 2 weeks before the start of the study

Where this trial is running

Ottawa, Ontario

• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Luke Witherspoon — Ottawa Hospital Research Institute
• Study coordinator: Amanda Ross

Conditions Peyronies Disease; Peyronies disease