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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares the outcomes of two treatments for Peyronie's Disease, a condition that causes curved, painful erections. Participants will receive either collagenase clostridium histolyticum (an enzyme injection to break down scar tissue, also known as Xiaflex) or undergo surgery. Both groups will also perform penile traction therapy (PTT) to enhance results. Men with a penile curvature of 30 degrees or more who can achieve an erection suitable for intercourse, with or without medication, qualify as good candidates for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research has shown that Xiaflex, a treatment for Peyronie's disease, is generally safe. Large studies found no unusual side effects. The FDA has approved the treatment, indicating it has passed safety checks for this condition.

For surgical options like incision and grafting or penile plication, studies have shown these are safe and effective. Most patients experience successful outcomes without major issues.

In summary, studies on people with Peyronie's disease have found both Xiaflex and the surgical treatments to be safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for Peyronie's Disease because they combine surgery and medication in innovative ways. Unlike traditional treatments that often involve just surgery or medication alone, this approach integrates Collagenase Clostridium Histolyticum (CCH) with either penile plication or incision and grafting surgeries. CCH is an enzyme known for breaking down collagen, which is a key component of the plaque causing the condition. Additionally, the use of postoperative penile traction therapy (PTT) is another highlight, as it might enhance the effectiveness and outcomes of these interventions. Together, these methods aim to improve penile curvature and function more effectively than existing treatments.

What evidence suggests that this trial's treatments could be effective for Peyronie's Disease?

Research has shown that Xiaflex, which contains collagenase clostridium histolyticum (CCH), may help with Peyronie's Disease. One large study found that Xiaflex reduced the bend in the penis by an average of 34%. Another study reported that 69 patients experienced significant improvements after receiving CCH injections. In this trial, some participants will receive CCH injections followed by penile traction therapy (PTT).

Surgery is also effective, with studies indicating it can improve the bend and result in a satisfactory appearance. Surgical success rates are high, with some studies reporting up to 82% of patients being satisfied. In this trial, other participants will undergo either penile plication or incision and grafting (I&G) surgery, followed by PTT. Both treatments offer clear benefits and provide different options for managing the condition. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

I am older than 18 years.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8451611/

Peyronie's disease – outcomes of collagenase clostridium ... The capstone CCh study was the IMPRESS trial thatshowed a 34% reduction in curvature with a mean (SD) – 17.0 (14.8)° reduction with IL CCh,while men in the ...

2. peyronies-disease.xiaflex.com peyronies-disease.xiaflex.com/hcp/efficacy-safety/study-design/

Study Design XIAFLEX is the only FDA-approved treatment evaluated in 2 large multicenter studies of patients with Peyronie's disease (PD).

3. academic.oup.com academic.oup.com/smr/article/12/3/497/7655837

Efficacy of collagenase Clostridium histolyticum combination ... In meta-analyses of CCH combined treatment for PD disease, results consistently showed significant improvements in penile length, PDQ-SB, and ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.780956/full

Efficacy and Safety of Collagenase Clostridium ... A clinical trial found that, after two CCH injections, 69 patients had a significant improvement in mean percent change for PCD, and the average ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429522008305

Improved Peyronie's Disease Curvature Outcomes Using a ... Results from the current study demonstrate significantly greater curvature and subjective improvements among men treated with a novel, more aggressive CCH ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25388099/

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

7. aetna.com aetna.com/cpb/medical/data/1000_1099/1061.html

Collagenase Clostridium Histolyticum (Xiaflex) The safety and effectiveness of Xiaflex for the treatment of Peyronie's disease were established in 2 randomized double-blind, placebo-controlled studies in 832 ...

8. academic.oup.com academic.oup.com/jsm/article/22/5/794/8113152

Are patients undergoing intralesional collagenase Clostridium ... Overall compliance rate for CCH injection therapy was 70.89%. Greater curvature reduction was demonstrated in compliant patients. Common reasons ...