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Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease

Primary Purpose

Peyronies Disease

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage

About this trial

This is an interventional treatment trial for Peyronies Disease focused on measuring Peyronies Disease, Fractionated Carbon Dioxide Laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.
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.
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.

Sites / Locations

Diamond Health Care Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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)

Full Information

NCT ID

NCT04326465

First Posted

August 12, 2019

Last Updated

May 9, 2023

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT04326465

Brief Title

Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease

Official Title

Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peyronies Disease

Keywords

Peyronies Disease, Fractionated Carbon Dioxide Laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measured reduction in penile curvature

Description

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).

Time Frame

Change in penile measurements (Baseline vs. Week 18, 24, & 52).

Secondary Outcome Measure Information:

Title

International Index of Erectile Function Questionnaire

Description

Self-reported 15-item questionnaire that assesses erectile dysfunction. Each item is scored from 0 to 5, yielding a total of 0 to 75.

Time Frame

Change in International Index of Erectile Function Questionnaire score (Baseline vs. Week 18, 24, & 52).

Title

Peyronie's Disease Questionnaire

Description

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)

Time Frame

Change in Peyronie's Disease Questionnaire score (Baseline vs. Week 18, 24, & 52).

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Flannigan, MD

Organizational Affiliation

UBC Faculty of Medicine - Department of Urologic Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diamond Health Care Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z1M9

Country

Canada

12. IPD Sharing Statement

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Fractionated Carbon Dioxide Laser Therapy for Treatment of Peyronie's Disease

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