Predictors of Pursuing Intralesional Xiaflex in Peyronie’s Disease Patients

Nahid Punjani MD, MPH; Bruno Nascimento MD; Carolyn Salter MD; Jose Flores MD; Eduardo Miranda MD; Jean Terrier MD; Hisanori Taniguchi MD;

Lawrence Jenkins MD; John P. Mulhall MD, MSc, FECSM, FACS

FIRST PUBLISHED: July 3, 2021 – The Journal of Sexual Medicine

DOI: https://doi.org/10.1016/j.jsxm.2021.05.006

Introduction 

In 2013, Xiaflex – a protocol of intralesional collagenase clostridium histolyticum (CCH) injections – was approved in the United States for the treatment of Peyronie’s disease. Patients are eligible to receive Xiaflex injections if they have dorsal or dorsolateral curvature ranging from 30 degrees to 90 degrees.

While this approach is considered safe and effective, many patients eligible for Xiaflex may choose penile reconstructive surgery or elect to not proceed with any treatment instead. This study investigated the factors that prompted men to choose Xiaflex.

Methods

Study Population 

The study involved 450 men (average age 55.5; P value = .14) with stable Peyronie’s disease who were seen at one United States medical center between 2013 and 2019. About 83% of the men were partnered (P value = .411).

All of the men:

• Were in the stable phase of Peyronie’s disease, with no changes in deformity for at least 3 months. They did not have flaccid penile pain or plaque tenderness.
• Had documented penile curvature following in-office intracavernosal injection.
• Had penile duplex ultrasound (DUS) within 6 months before the start of Xiaflex therapy.
• Had a standardized, structured discussion of therapeutic options with the study’s senior investigator before starting any intervention.

Standardized Peyronie’s Disease Treatment Discussion 

Counseling conversations with the senior investigator included the following topics:

• Pathophysiology of Peyronie’s disease.
• Natural history of Peyronie’s disease.
• The fact that treatment was intended for men with physical impairment and/or psychological bother.
• Xiaflex protocol, including candidacy for treatment, structure of program, required daily traction, potential complications, and potential outcomes.

Patients decided on their treatment plans within 3 months of their curvature assessment.

Xiaflex Program

The treatment protocol included 5-10 intralesional injections administered over 14–28 weeks. A cycle included 2 injections spaced a week apart. A 6-week waiting period followed each cycle.

Injections were not continued if 1) there was no improvement 2) there was significant improvement or 3) patients were satisfied.

Patients who had some improvements, but not full satisfaction received 2 more cycles of treatment.

Penile Curvature Assessment

Men were given intracavernosal injections to induce erections. At this point, the penis was visually assessed and measured. Plaque calcifications and erectile hemodynamics were evaluated during duplex penile ultrasound. Men who had curvature over 60 degrees, multiplanar curvature, or hourglass deformities were considered to have complex deformity.

Questionnaires

The men completed the Peyronie’s Disease Questionnaire (PDQ), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Self-Esteem and Relationship (SEAR) questionnaire.

Results

Approximately 25% of the participants (111 men) chose Xiaflex treatment, and 75% (339 men) did not.

About 38% of the Xiaflex group had had Peyronie’s disease for over a year, compared to 26% of the non-Xiaflex group (P value = .133).

The rate of complex curvature was higher in the Xiaflex group compared to the men who did not choose Xiaflex (79% and 48%, respectively; P value < .01). The Xiaflex group was more likely to have curvature over 60 degrees (26% for Xiaflex group, 7% for non-Xiaflex group; P value < .01) and at least moderate instability (32% for Xiaflex group, 15% for non-Xiaflex group; P value = .01).

Men in the Xiaflex group tended to have higher scores on the PDQ, but CES-D scores and SEAR scores were similar for the two groups.

Discussion and Conclusion

“Significant bother, curve complexity, multiplanarity, significant curvature and PDQ scores were associated with [Xiaflex] use on univariable analysis. Only axial load instability and significant bother were predictive of [Xiaflex] usage on multivariable analysis.”

Peyronie’s disease can greatly affect quality of life and leads to depression in many men. However, CED-D scores were similar for men in both the Xiaflex group and the non-Xiaflex group, “suggesting that [depression] has little impact upon opting for [Xiaflex] as treatment.”

Several limitations were acknowledged:

• The study had a retrospective design and involved just one institution.
• Researchers assumed that patients did not seek Xiaflex treatment elsewhere.
• Insurance data was not available for all patients.
• Treatment outcomes are not addressed in the study.
• The study has limited generalizability outside the United States.