Peyronies DiseaseNCT04326465
Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease
A study testing Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage in people with Peyronies Disease, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronies Disease
- What is being tested?
- Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Show all 10Show fewer
- 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.
- Received an investigation drug or treatment within 30 days before start of the study.
- At any time, received Collagenase clostridium histolyticum for the treatment of Peyronie's Disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Peyronies Disease
- Being tested
- Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage
- Keywords
- Peyronies Disease, Fractionated Carbon Dioxide Laser
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density CoverageDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage | Experimental | 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. Receives: Device: Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured reduction in penile curvature
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).
Measured: Change in penile measurements (Baseline vs. Week 18, 24, & 52).
Secondary outcomes (2)
International Index of Erectile Function Questionnaire
Self-reported 15-item questionnaire that assesses erectile dysfunction. Each item is scored from 0 to 5, yielding a total of 0 to 75.
Measured: Change in International Index of Erectile Function Questionnaire score (Baseline vs. Week 18, 24, & 52).
Peyronie's Disease Questionnaire
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)
Measured: Change in Peyronie's Disease Questionnaire score (Baseline vs. Week 18, 24, & 52).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronies DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Flannigan, MD, University of British Columbia
- Investigators
- Ryan Flannigan, MD, Principal investigator, UBC Faculty of Medicine - Department of Urologic Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326465
- Sponsor's protocol ID
- H18-02482
- Status last verified
- May 2024
- First submitted
- 12 Aug 2019
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease
- ClinicalTrials.gov ID
- NCT04326465
- Acronym / sponsor ID
- H18-02482
- Conditions
- Peyronies Disease
- Keywords
- Peyronies Disease, Fractionated Carbon Dioxide Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage | Experimental | Device: Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density CoverageStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Isolated hourglass deformity of the penis without curvature.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density CoverageFractional 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. | Device | Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage |
Primary outcome
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).
2 secondary outcomes
International Index of Erectile Function Questionnaire
Time frame: Change in International Index of Erectile Function Questionnaire score (Baseline vs. Week 18, 24, & 52).
Peyronie's Disease Questionnaire
Time frame: Change in Peyronie's Disease Questionnaire score (Baseline vs. Week 18, 24, & 52).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Related trials for Peyronies Disease
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Platelet-Rich Plasma for Peyronie's Disease
Peyronies Disease
Active, not recruitingPhase 4
Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Peyronie Disease
Active, not recruitingPhase 4
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Peyronie's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Flannigan, MD principal investigator
UBC Faculty of Medicine - Department of Urologic Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage in people with Peyronies Disease, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured reduction in penile curvature (time frame: Change in penile measurements (Baseline vs. Week 18, 24, & 52).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.