Status:
RECRUITING
Title Fractioned CO2 Laser in the Treatment of Chronic Phase Peyronie's Disease
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Peyronies Disease
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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 ca...
Eligibility Criteria
Inclusion
- 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.
- 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).
- 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)
- Signed informed REB-approved consent agreement; signed authorization form to allow disclosure of protected information.
- Ability to read, complete, and understand the various rating instruments in English.
Exclusion
- Penile curvature of \<30º or \>90º
- 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.
- 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.
- Calcified plaque as evident by appropriate radiographic evaluation, i.e., penile ultrasound that would prevent treatment with Fractional CO2 Laser
- Isolated hourglass deformity of the penis without curvature
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07177833
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 17 2025
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y4E9