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Variation in collagenase Clostridium histolyticum practice patterns: a Survey of ISSM Members
T A Masterson1, A Galante2, M Butaney3
1Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA.
Insights
Practitioners using Collagenase clostridium histolyticum (CCH) for Peyronie's disease often deviate from package insert guidelines. Provider satisfaction with CCH treatment was not linked to adherence to these official recommendations.
Area of Science:
- Urology
- Sexual Medicine
- Pharmacology
Background:
- Collagenase clostridium histolyticum (CCH) is the sole FDA-approved medication for Peyronie's disease.
- Current understanding of real-world CCH usage patterns among practitioners is limited.
Purpose of the Study:
- To investigate practice variations in CCH use.
- To evaluate adherence to CCH package insert guidelines.
- To determine if provider satisfaction correlates with guideline adherence.
Main Methods:
- An online survey was administered to 1270 International Society for Sexual Medicine (ISSM) members.
- A 30-question survey assessed CCH usage patterns and adherence to package insert recommendations.
- Adherence scores were calculated, and statistical tests (t-test, chi-squared) were used for analysis.
Main Results:
- A 10.4% response rate (202 total, 132 CCH users) was achieved.
- Only 11% of practitioners adhered to all evaluated package insert recommendations, despite 67% believing they did.
- Provider satisfaction was not significantly associated with adherence scores.
Conclusions:
- Significant variability exists in CCH practice patterns, with low adherence to package insert guidelines.
- Provider satisfaction with CCH treatment is not dependent on adherence to official guidelines.
- These findings offer insights for practitioners considering alternative CCH administration methods based on emerging data.
Abstract:
Collagenase clostridium histolyticum (CCH, Xiaflex, Xiapex) is the only FDA-approved medication for treatment of Peyronie's disease. It is unclear how practitioners actually use CCH in their own practices. The objectives of the study were: (1) to identify variability in practice patterns for CCH among practitioners, (2) to assess adherence to the package insert instructions, and (3) to evaluate whether provider satisfaction was associated with adherence to instructions. A 30-question online survey was distributed to 1270 members of the International Society for Sexual Medicine (ISSM) from the EU, USA, Canada and Australia. Of the 30 questions, 10 survey questions had only one response consistent with the CCH package insert recommendations. An "adherence" score was calculated for each survey participant depending on how many of these questions were answered correctly. The average adherence scores of various groups were compared using a student's t-test. A chi-squared test was used to determine association between categorical variables. Of 202 total responses, 132 practitioners reported using CCH out of 1270 ISSM members from countries where CCH is available (10.4% response rate). Practitioners from outside the USA were more likely to be satisfied with CCH (p = 0.006), and more experienced users (>20 uses) were more likely to be satisfied than less experienced users (<10 uses) (p = 0.046). Satisfied users of CCH did not have significantly different adherence scores than non-satisfied users. Even though 67% of practitioners believed they followed the package insert guidelines, only 11% adhered to all the recommendations evaluated by the survey. Treatment adherence to package insert guidelines does not appear to be associated with provider satisfaction. We believe there is utility in seeing a snapshot of these practice patterns so practitioners may feel more comfortable adapting their own practice in light of newer data supporting alternative administration methods.
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