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

RecruitingPhase 1Ages 18 Years - anyMaleOttawa Hospital Research Institute
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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
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What it tests

  • Fractional CO2 laser
  • Sham (No Treatment)
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Where

1 site
The Ottawa Hospital
Ottawa, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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