Surgery + Xiaflex + RestoreX for Peyronie's Disease

(iSCRIP Trial)

Overseen By Benjamin D. Green, Economics/MA

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Disqualifiers: Prior CCH or surgery, Penile calcification, Others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

40 Participants Needed

Trial Summary

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 drug Collagenase Clostridium Histolyticum (Xiaflex) for treating Peyronie's Disease?

Research shows that Collagenase Clostridium Histolyticum (Xiaflex) significantly improves penile curvature and reduces discomfort in men with Peyronie's Disease, as demonstrated in multiple phase III studies. The drug is generally well tolerated, with most side effects being mild or moderate. ^{1 2 3 4 5}

Is the combination of Surgery, Xiaflex, and RestoreX safe for treating Peyronie's Disease?

Xiaflex (Collagenase Clostridium Histolyticum) is generally well tolerated for treating Peyronie's Disease, with most side effects being mild or moderate. However, serious side effects like penile hematoma (bruising) or corporal rupture (tear in the penile tissue) can occur, though they are rare. ^{2 3 4 5 6}

How is the treatment with Surgery + Xiaflex + RestoreX for Peyronie's Disease different from other treatments?

This treatment combines surgery with Xiaflex, a drug that breaks down collagen in the penile plaque, and RestoreX, a device for penile traction therapy. This combination aims to improve penile curvature and function more effectively than using Xiaflex or surgery alone, offering a comprehensive approach to managing Peyronie's Disease. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial compares enzyme injections with a stretching device to surgery with a stretching device for men with Peyronie's Disease. The enzyme helps dissolve scar tissue, while surgery corrects curvature. Both methods use a stretching device to help reshape and maintain the penis.

Eligibility Criteria

Men over 18 with Peyronie's Disease (PD) who have a curvature of at least 30 degrees and can achieve an erection suitable for intercourse, with or without medication. Men who've had previous treatments with collagenase or surgery, or have moderate to severe penile calcification cannot participate.

Inclusion Criteria

I can have an erection good enough for sex, with or without medication.

I am a man diagnosed with Parkinson's disease.

Your spine is abnormally curved more than 30 degrees.

Exclusion Criteria

Moderate (shadowing) or severe (>1 cm) penile calcification

I have no health issues that prevent me from undergoing specific treatments or surgery.

I have had previous treatment with CCH or surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either collagenase clostridium histolyticum injections or undergo surgery, followed by penile traction therapy

3 months

Multiple visits for injections or surgery and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of penile curvature, satisfaction, and erectile function

1 year

Treatment Details

Interventions

• Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)
• Incision and Grafting (I&G) Surgery
• Penile Plication Surgery
• RestoreX Penile Traction Device

Trial Overview This study compares the effectiveness of collagenase injections versus two types of surgery (Incision & Grafting and Penile Plication) in managing PD. It also examines the use of a RestoreX Penile Traction Device as part of treatment.

Participant Groups

Group I: Surgery+PTT Active Control 3 Interventions

Men will undergo either penile plication or I\&G based on appropriate clinical criteria for either surgery. 2-4 weeks post-operatively (depending on tolerability), the patients will be asked to perform PTT 30-60 minutes daily until the 3-month post-treatment visit.

Group II: CCH+PTT Active Control 2 Interventions

Men will receive two injections of CCH administered 1-3 days apart, followed by manual modeling and PTT 30-60 min/day as outlined in our prior publication. Approximately 6 weeks later, the next round of injections will be performed until a maximum of 8 injections in total has been administered. PTT will be continued until the 3-month post-treatment visit.

Who Is Running the Clinical Trial?

Charitable Union for the Research and Education of Peyronie's Disease

Lead Sponsor

Trials

6

Recruited

920+

Endo Pharmaceuticals

Industry Sponsor

Trials

136

Recruited

33,700+

Matthew Davis

Endo Pharmaceuticals

Chief Medical Officer since 2016

MD

Scott Hirsch

Endo Pharmaceuticals

Chief Executive Officer

BA in Economics from Princeton University

Findings from Research

Collagenase Clostridium Histolyticum (CCH) significantly improved penile curvature and reduced discomfort in men with Peyronie's disease, based on results from the 52-week phase III IMPRESS I and II studies.

CCH was generally well tolerated, with serious side effects occurring in less than 1% of patients, indicating it is a safe and effective minimally invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium Histolyticum: A Review in Peyronie's Disease. Dhillon, S.[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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium Histolyticum: A Review in Peyronie's Disease. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Collagenase Clostridium Histolyticum: A Review in Peyronie's Disease. [2018]

3. 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]

4. 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]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

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