Shockwave Therapy + Xiaflex for Peyronie's Disease

Overseen By Wyatt H Anians, CCRP

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Prior PD surgery, Severe penile pain, Moderate ED, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for Peyronie's Disease?

Research shows that collagenase clostridium histolyticum (CCH), also known as Xiaflex, is effective and safe for treating Peyronie's disease, as it is the only licensed medical treatment for this condition and has been shown to improve symptoms in multiple studies. ^{1 2 3 4 5}

Is Shockwave Therapy + Xiaflex safe for treating Peyronie's Disease?

Collagenase Clostridium histolyticum (Xiaflex) is generally considered safe for treating Peyronie's Disease, with studies showing it as an effective non-surgical option. However, rare complications like corporal rupture and lateral herniation have been reported. ^{1 2 3 6 7}

What makes the drug Xiaflex unique for treating Peyronie's disease?

Xiaflex is unique because it is an FDA-approved drug specifically designed to treat Peyronie's disease by breaking down the collagen buildup in the penis, which causes the curvature. It is administered through injections directly into the affected area, offering a non-surgical option for patients. ^{1 2 8 9 10}

Research Team

Tobias Kohler, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Men with Peyronie's Disease (PD) who have a significant bend in their penis (30-90 degrees), can feel the plaque causing the curve, and whose symptoms have been stable for at least 3 months. They shouldn't have had previous treatments for PD, severe pain or erectile dysfunction, certain types of penile curvature, or heavy plaque calcification.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)

I can feel a lump in my penis.

Exclusion Criteria

I have had shockwave therapy for sexual dysfunction.

I have had injections or surgery for Peyronie's disease.

I have moderate to severe erectile dysfunction.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with or without low-intensity shockwave therapy (LiSWT)

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Collagenase Clostridium Histolyticum
• Low Intensity Shockwave Therapy

Trial Overview The trial is testing if combining low-intensity shockwave therapy with Xiaflex injections improves straightening of the penis better than previous treatments alone. Participants will receive both therapies to see if there's greater improvement in penile curvature.

Participant Groups

Group I: Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy Experimental Treatment 2 Interventions

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).

Group II: Collagenase Clostridium Histolyticum Active Control 1 Intervention

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

Collagenase Clostridium Histolyticum is already approved in United States, European Union for the following indications:

Approved in United States as Xiaflex for:

• Peyronie's disease
• Dupuytren's contracture

Approved in European Union as Xiaflex for:

• Peyronie's disease
• Dupuytren's contracture

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study of 53 patients with Peyronie's disease, a new modified treatment protocol using only three injections of collagenase clostridium histolyticum (CCH) resulted in a significant improvement in penile curvature, with 96.2% of patients showing an average reduction of 17.36° from a baseline curvature of 54° (P < 0.001).

The modified protocol was found to be safe and well-tolerated, with only mild and transient local side effects, and its efficacy was comparable to traditional protocols that required eight injections, making it a more cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. Abdel Raheem, A., Capece, M., Kalejaiye, O., et al.[2018]

In a phase 3 study involving 347 men with Peyronie's disease, collagenase clostridium histolyticum (CCH) demonstrated a significant mean improvement of 34.4% in penile curvature deformity and a reduction of 3.3 points in the PD symptom bother score after 36 weeks of treatment.

CCH was generally well tolerated, with most adverse events being mild or moderate, and only three serious treatment-related adverse events were reported, all of which resolved with treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. Levine, LA., Cuzin, B., Mark, S., et al.[2022]

In a phase 2b study involving 147 subjects, collagenase Clostridium histolyticum significantly improved penile curvature by 29.7% compared to 11.0% in the placebo group, indicating its efficacy as a treatment for Peyronie disease.

The treatment was well tolerated with mostly mild to moderate adverse events occurring at the injection site, and no serious treatment-related adverse events were reported, suggesting it is a safe nonsurgical option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. Gelbard, M., Lipshultz, LI., Tursi, J., et al.[2022]

In a study of 135 men with stable Peyronie's disease, a modified treatment protocol using Collagenase Clostridium histolyticum (CCH) injections significantly improved penile curvature by an average of 19.07 degrees and enhanced sexual function for both patients and their partners.

The treatment resulted in a high global satisfaction rate of 89.6%, indicating that CCH injections not only benefited the patients but also positively impacted their partners' sexual function, although the study had limitations such as the lack of a placebo group and long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. Cocci, A., Russo, GI., Salonia, A., et al.[2019]

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 the first licensed non-surgical treatment for Peyronie's disease (PD), demonstrating safety and efficacy in large phase III trials (IMPRESS I and II) involving men with PD.

The authors introduced a new shortened modified protocol for CCH that maintains safety and efficacy while reducing treatment costs and duration, potentially increasing access for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol. Abdel Raheem, A., Johnson, M., Abdel-Raheem, T., et al.[2018]

Collagenase Clostridium histolyticum (CCH), known as Xiaflex, is an effective non-surgical treatment for Peyronie's disease, but it can lead to rare complications such as lateral herniation of the tunica albuginea, as demonstrated in a case involving a 58-year-old male.

The patient experienced a painless swelling on the left side of the penis after CCH injections, indicating a potential herniation rather than a rupture, highlighting the need for awareness of this rare side effect during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral herniation during treatment with collagenase Clostridium histolyticum (Xiaflex) for Peyronie's disease. Gannon, MK., Pearlman, AM.[2021]

A survey of 47 urology programs revealed that while 95.7% of residents receive training in evaluating and managing Peyronie's disease, only 66.0% receive training specifically on the non-surgical treatment with Xiaflex®, indicating a significant gap in exposure to this FDA-approved therapy.

Most training on Xiaflex® is provided by fellowship-trained sexual medicine faculty, but there is a need for more comprehensive exposure to ensure residents are well-prepared to use this treatment effectively in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of exposure to the use of Xiaflex for the treatment of Peyronie's disease among United States urology residency programs. Loloi, J., Schuppe, K., Reddy, RV., et al.[2023]

Xiaflex, an injectable treatment for Peyronie's disease, has been found to be both safe and effective as a first-line therapy.

The study supports the use of collagenase Clostridium histolyticum injections, indicating they can effectively reduce the curvature associated with Peyronie's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Xiaflex for Treatment of Peyronie's Disease. Shin, D., Shah, T., Sadeghi-Nejad, H.[2018]

In a study of 450 stable Peyronie's disease patients, only 24.7% opted for intralesional collagenase (ILX) treatment, indicating that it is not the most common choice among patients.

Patients who chose ILX were more likely to experience significant bother and had more complex curvature and moderate to severe instability, suggesting that these factors are important predictors for deciding to pursue this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Pursuing Intralesional Xiaflex in Peyronie's Disease Patients. Punjani, N., Nascimento, B., Salter, C., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie's disease using a new modified shortened protocol. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. [2022]

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

Phase 2b study of the clinical efficacy and safety of collagenase Clostridium histolyticum in patients with Peyronie disease. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Predictive Factors of Patients' and Their Partners' Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. [2019]

5. 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]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Lateral herniation during treatment with collagenase Clostridium histolyticum (Xiaflex) for Peyronie's disease. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A survey of exposure to the use of Xiaflex for the treatment of Peyronie's disease among United States urology residency programs. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Xiaflex for Treatment of Peyronie's Disease. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of Pursuing Intralesional Xiaflex in Peyronie's Disease Patients. [2022]