Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease (NCT04326465) | Clinical Trial Compass
CompletedNot Applicable
Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease
Canada5 participantsStarted 2021-05-01
Plain-language summary
This is a pilot study that evaluates the use of Fractional Carbon Dioxide Laser Therapy in the treatment of Peyronie's Disease. Study participants will be assigned to receive Fractional Carbon Dioxide Laser Therapy at 10-15% laser density coverage.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Healthy males age 18 or older in a stable relationship with a female partner/spouse (for at least 3 months and willing to have vaginal intercourse with that female partner/spouse.
✓. Diagnosis of Peyronie's Disease for at least 12 months with evidence of stable disease as determined by the investigator.
✓. Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane (must have been possible to delineate the single plane of maximal curvature for evaluation).
✓. Signed informed Ethics-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 criteria
✕. 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; known active hepatitis B or C; known immune deficiency disease (including Human Immunodeficiency Virus).
✕. Failure to achieve a sufficient erection (after prostaglandin 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 Carbon Dioxide Laser.
What they're measuring
1
Measured reduction in penile curvature
Timeframe: Change in penile measurements (Baseline vs. Week 18, 24, & 52).
. Isolated hourglass deformity of the penis without curvature.
✕. Treatment or plans to undergo treatment for Peyronie's Disease, 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.
✕. Use of or plans to use a mechanical devices to induce a passive erection within 2 weeks before the start of study.
✕. Erectile dysfunction that was unresponsive to Phosphodiesterase inhibitors.