CO2 Laser Therapy for Peyronie's Disease

Overseen By Justin Chan, BMSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Phosphodiesterase inhibitors

Disqualifiers: Penile conditions, Erectile dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a laser therapy to treat men with Peyronie's Disease by breaking down scar tissue in the penis, aiming to improve its shape and function without invasive procedures. Laser therapy has been proposed with success in the treatment of Induratio Penis Plastica (IPP), also called Peyronie's Syndrome.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used oral or topical agents for Peyronie's Disease within 3 months before the study.

What data supports the effectiveness of CO2 Laser Therapy for Peyronie's Disease?

The research mentions laser therapy as one of the medical treatments available for Peyronie's disease, suggesting it might be valuable, especially in the early stages. However, no single treatment has been proven superior, and combination therapy is recommended until more studies are conducted. ^{1 2 3 4 5}

Is CO2 laser therapy generally safe for humans?

A study involving 12 patients used carbon dioxide laser therapy to treat Peyronie's plaque, and it was described as a versatile procedure, suggesting it was safely applied in these cases. ^{6 7 8 9 10}

How does CO2 laser therapy differ from other treatments for Peyronie's disease?

CO2 laser therapy for Peyronie's disease is unique because it uses a focused laser beam to precisely remove plaque without creating large defects, which reduces the need for extensive grafting. This method can also remove calcifications and is combined with a patch graft to correct curvature, offering a surgical option that preserves potency and improves penile curvature. ^{5 8 11 12 13}

Research Team

Ryan Flannigan, MD

Principal Investigator

UBC Faculty of Medicine - Department of Urologic Sciences

Eligibility Criteria

This trial is for healthy males aged 18 or older, diagnosed with Peyronie's Disease for at least a year and have stable disease. They must be in a stable relationship, able to read and understand English, and willing to sign consent forms. Men with penile curvature between 30º-90º are eligible.

Inclusion Criteria

You are willing to have vaginal intercourse with a female partner/spouse

Penile curvature of 30º-90º in the dorsal, lateral, or dorsal/lateral plane.

You have Peyronie's disease for at least 12 months with evidence of stable disease as determined by the investigator.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants receive Fractional Carbon Dioxide Laser Therapy sessions every six weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up appointments at Week 18, 24, and 52

52 weeks

3 visits (in-person)

Treatment Details

Interventions

• Fractional Carbon Dioxide Laser Therapy

Trial Overview The study tests Fractional Carbon Dioxide Laser Therapy as a treatment for Peyronie's Disease. Participants will receive this therapy at a laser density coverage of 10-15%. It's designed to see if the laser can help reduce symptoms of the disease.

Participant Groups

Group I: Fractional CO2 Laser Therapy at 10-15% Laser Density Coverage Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

Collagenase clostridium histolyticum (CCH) therapy significantly improved penile curvature in men with Peyronie's disease over a 5-year period, with improvements of 20.9° in those with no calcification and similar results in those with stippled or interfering calcification.

No long-term safety issues were identified, indicating that CCH is a safe and effective nonsurgical treatment option for men with Peyronie's disease, even in cases of plaque calcification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Curvature Deformity Characterization in Men Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease, Subgrouped by Penile Plaque Calcification. Goldstein, I., McLane, MP., Xiang, Q., et al.[2022]

In a study of 918 patients with Peyronie's disease, treatment with collagenase Clostridium histolyticum resulted in a significant improvement in penile curvature, reducing the average curvature from 48.2 degrees to 32.9 degrees, which is a 30.1% improvement.

The treatment was found to be safe, with only 9% of patients experiencing complications, and the number of treatment cycles was positively correlated with the degree of curvature improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional Collagenase Clostridium histolyticum Causes Meaningful Improvement in Men with Peyronie's Disease: Results of a Multi-Institutional Analysis. Hellstrom, WJG., Tue Nguyen, HM., Alzweri, L., et al.[2019]

Collagenase clostridium histolyticum (CCH) is effective in treating ventral penile curvatures caused by Peyronie's Disease, with significant improvements observed in curvature after treatment, particularly for ventral (49% improvement) and lateral (38% improvement) curvatures compared to dorsal (25% improvement).

The treatment was found to have a similar safety profile across different curvature directions, with no urethral complications reported, indicating that CCH is a safe option for men with ventral Peyronie's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. Alom, M., Meng, Y., Sharma, KL., et al.[2020]

A 69-year-old man with penile lichen sclerosus underwent five treatments with a fractional micro-ablative CO2 laser, showing significant symptom improvement after the first session.

Complete clinical remission was achieved 14 weeks after the final treatment, suggesting that this laser therapy could be an effective alternative to traditional treatments like topical steroids or circumcision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractional Micro-ablative CO2 Laser as Therapy in Penile Lichen Sclerosus. Campolmi, P., Cannarozzo, G., Bennardo, L., et al.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Peyronie's disease: treatment with interferon and laser]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The medical management of Peyronie's disease. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Superficial radiation therapy in peyronie's disease: An effective and well-tolerated therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Conservative management options for Peyronie's disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Experience With Penile Traction Therapy Among Men Undergoing Collagenase Clostridium histolyticum for Peyronie Disease. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term Curvature Deformity Characterization in Men Previously Treated With Collagenase Clostridium Histolyticum for Peyronie's Disease, Subgrouped by Penile Plaque Calcification. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Intralesional Collagenase Clostridium histolyticum Causes Meaningful Improvement in Men with Peyronie's Disease: Results of a Multi-Institutional Analysis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Peyronie's plaque: surgical treatment with the carbon dioxide laser and a deep dorsal vein patch graft. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Collagenase Clostridium Histolyticum in Peyronie's Disease Men With Ventral Curvatures. [2020]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Peyronie's disease and low intensity shock wave therapy: Clinical outcomes and patient satisfaction rate in an open-label single arm prospective study in Australian men. [2019]

11. Iran pubmed.ncbi.nlm.nih.gov

Fractional Micro-ablative CO2 Laser as Therapy in Penile Lichen Sclerosus. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Long-term followup of treatment of Peyronie's disease with plaque incision, carbon dioxide laser plaque ablation and placement of a deep dorsal vein patch graft. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Peyronie's disease: A contemporary review of non-surgical treatment. [2020]