Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease
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|ClinicalTrials.gov Identifier: NCT04326465|
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : May 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peyronies Disease||Device: Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage||Not Applicable|
Peyronie's Disease is a fibrosing disorder of the penis where scar tissue known as a "plaque" forms along the shaft of the penis. This plaque can lead to penile deformity, erectile dysfunction and pain during intercourse. Furthermore, Peyronie's Disease has been shown to negatively affect the quality of life and cause psychosocial distress. Currently, treatments for Peyronie's Disease are invasive (injections or surgery). This study investigates the use of a non-invasive and extra-dermal Fractional Carbon Dioxide Laser Therapy to treat chronic phase Peyronie's Disease.
Fractional Carbon Dioxide Laser Therapy works by destroying and reducing abnormal collagen (a major component found in Peyronie's Disease plaques) in scarred tissue. Although Fractional Carbon Dioxide Lasers have yet to be used in the field of urology, it has already been used safely and successfully to treat conditions similar to Peyronie's Disease (ie. hypertrophic burn scars).
Study participants enrolled in this study will be required to attend 6 study visits. The first study visit is a 'Screening Visit'. At this visit, a medical history and baseline penile measurements (degree of curvature, stretched length, and circumference deformity at flaccid and erect states) will be collected. Study participants will also be asked to complete the International Index of Erectile Function Questionnaire and Peyronie's Disease Questionnaire.
Following the 'Screening Visit', study participants will be scheduled for three Fractional Carbon Dioxide Laser Therapy sessions. These sessions will be scheduled once every six weeks (totalling 12 weeks from the first therapy session).
Following, the last Fractional Carbon Dioxide Laser Therapy session, there will be three follow-up appointments (Week 18, Week 24, Week 52). At these visits, post-therapy penile measurements, International Index of Erectile Function, and Peyronie's Disease scores will be collected.
Digital photographs may be taken as part of the study's analysis and to track the progress of Fractional CO2 Laser Therapy. You will have the option to deny any digital photography.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Efficacy and safety trial for Fractional CO2 Laser Therapy with pre- and post-treatment comparisons (3 laser therapy sessions over 12 weeks in men with Peyronie's Disease).|
|Masking:||None (Open Label)|
|Official Title:||Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease|
|Actual Study Start Date :||May 1, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage
Study participants with Peyronies Disease will be treated with a Fractional Carbon Dioxide Laser set at a 10-15% laser density. The patient will receive three laser therapy sessions over 12 weeks (one session every four weeks). Following each session, topical triamcinolone will be applied to the treated area.
Device: Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage
Fractional Carbon Dioxide Laser Therapy is an ablative therapy where abnormal collagen in scarred tissue is destroyed to permit the formation of more organized collagen. Previous studies have demonstrated its efficacy in treating medical conditions (ex. hypertrophic scars) similar to Peyronies Disease. There is evidence that Fractional Carbon Dioxide Laser Therapy has the ability to target and alter the molecular pathways that are similar to the ones that lead to Peyronie's Disease.
- Measured reduction in penile curvature [ Time Frame: Change in penile measurements (Baseline vs. Week 18, 24, & 52). ]Penile measurements will be collected at erect states. Penile measurements will be conducted at the screening visit (Baseline) and at the follow-up study visits (Week 18, 24, & 52).
- International Index of Erectile Function Questionnaire [ Time Frame: Change in International Index of Erectile Function Questionnaire score (Baseline vs. Week 18, 24, & 52). ]Self-reported 15-item questionnaire that assesses erectile dysfunction. Each item is scored from 0 to 5, yielding a total of 0 to 75.
- Peyronie's Disease Questionnaire [ Time Frame: Change in Peyronie's Disease Questionnaire score (Baseline vs. Week 18, 24, & 52). ]Self-reported 15-item questionnaire that assesses sexual function in individuals with Peyronie's Disease. Scoring of each item is varied (ie. Q1 scored 0 to 4, Q9 scored 0 to 10)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326465
|Contact: Justin Chan, BMScfirstname.lastname@example.org|
|Canada, British Columbia|
|Diamond Health Care Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: Ryan Flannigan, MD 6048755003 email@example.com|
|Principal Investigator:||Ryan Flannigan, MD||UBC Faculty of Medicine - Department of Urologic Sciences|