A modified technique for intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease results in reduced procedural morbidity using a standardized hematoma classification rubric

Amighi, Arash; Mills, Steven A.; Jiang, Tommy; Regets, K.; Mendhiratta, Neil; Mills, Jesse N.

doi:10.1007/s00345-019-02812-9

Cited by 16 publications

(9 citation statements)

References 20 publications

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“…Both patients were able to be managed non-operatively. 14 (6%) developed a hematoma based on a prior definition of hematoma (32). There were no statistically significant differences in number of TRAE between the acute and chronic phase groups using either definition (Table 5).…”

Section: Definition 1 or Definition 2 Of The Acute Phase Was Usedmentioning

confidence: 92%

“…A full course of therapy consisted of four treatment cycles, separated by six weeks, totaling 8 injections. Injections were performed using a previously described technique (32), followed by temporary application of a compressive wrap. Patients were instructed to perform flaccid penile modeling daily and abstain from sexual activity for 2 weeks after each cycle.…”

Section: Intralesional Injection Protocolmentioning

confidence: 99%

“…Adverse events were recorded at each follow-up clinic visit and were categorized into minor and major events. Minor adverse events were defined as injection-site swelling or bruising (non-palpable discoloration), and major events were defined as hematoma formation [ecchymosis with palpable collection based on prior definition (32)] or penile corporal rupture.…”

Section: Outcome Measuresmentioning

confidence: 99%

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Intralesional collagenase Clostridium histolyticum for acute phase Peyronie’s disease: a single-center, retrospective cohort study

Hu¹,

Sigalos²,

Walker³

et al. 2022

Transl Androl Urol

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Background: Peyronie's disease (PD) can be subdivided into acute and chronic phases. Intralesional collagenase Clostridium histolyticum has been shown to improve curvature in the chronic phase. Initial clinical trials excluded patients in the acute phase from treatment. Recent studies show comparable results among men in the acute phase. The definition of acute phase varies among existing studies, but it is generally understood to last 12-18 months and is accompanied by penile pain and progression of deformity. We sought to evaluate the safety and efficacy of intralesional collagenase injection therapy during the acute phase of PD using multiple definitions of the acute phase.Methods: All men receiving intralesional collagenase for PD from October 2015 through December 2020 at a single academic institution were retrospectively assessed for patient demographics and comorbidities, pre-and post-treatment curvature, and adverse events. Two definitions of acute phase were used: (I) acute phase duration ≤6 months, chronic phase duration >6 months; and (II) acute phase duration ≤12 months with penile pain, chronic phase duration >12 or no penile pain.Results: Of 330 patients identified, 229 underwent intralesional collagenase treatment with pre-and post-treatment erect penile goniometry. 65 (28%) met criteria for definition 1 of acute phase, 37 (16%) met criteria for definition 2, and 76 (33%) met criteria for either. Percent change in penile curvature was not significantly different between acute and chronic phases using definition 1 (16.0% vs. 16.6%, P=0.89), definition 2 (19.9% vs. 15.7%, P=0.43), or either (16.5% vs. 16.3%, P=0.96). The rates of development of bruising, swelling, hematoma, or corporal rupture were not significantly different between the acute and chronic phases under either definition (all P>0.05).Conclusions: This single-center, retrospective cohort analysis suggests that intralesional collagenase is both safe and effective for the treatment of men with acute phase PD. Limitations exist inherent to retrospective review, since many men did not return for post-treatment goniometry, possibly skewing our cohort toward incomplete responders. Prospective, randomized studies will be required to confirm these findings.

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Section: Definition 1 or Definition 2 Of The Acute Phase Was Usedmentioning

confidence: 92%

Section: Intralesional Injection Protocolmentioning

confidence: 99%

Section: Outcome Measuresmentioning

confidence: 99%

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Intralesional collagenase Clostridium histolyticum for acute phase Peyronie’s disease: a single-center, retrospective cohort study

Hu¹,

Sigalos²,

Walker³

et al. 2022

Transl Androl Urol

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“…Penile hematoma can be seen in some patients, and corporal rupture is a rare complication. 5–7 Recently in early 2021, post-marketing evaluation of intralesional collagenase in the nonclinical trial setting uncovered reports of postinjection acute lower back pain. This has prompted the following addition to the patient safety label for Xiaflex: “After receiving an injection of Xiaflex for PD, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms.…”

mentioning

confidence: 99%

Acute Lower Back Pain after Intralesional Injection of Collagenase Clostridium histolyticum for Peyronie’s Disease

Sigalos

Yoffe

et al. 2022

Journal of Urology

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Purpose: The safety label for collagenase Clostridium histolyticum was updated to include postinjection acute lower back pain as an adverse event observed with intralesional therapy for Peyronie's disease. Incidence and causality are unknown. We assessed frequencies and temporal associations for this adverse event in a large cohort. Materials and Methods: Data on all men undergoing collagenase injections for Peyronie's disease at our institution from October 2015 through December 2020 were retrospectively assessed. The study included 330 patients, 300 completing at least 1 full course (8 injections). Measured outcomes included incidence and timing of back pain, and associations with demographics and comorbidities. Results: Of 330 patients, 19 (5.8%) experienced at least 1 episode of postinjection acute lower back pain. Of 300 who completed at least 1 full course of 8 injections, 4 (1.3%) reported back pain within the 8-injection course. A subset underwent additional rounds (16 or 24 injections). Back pain increased to 8.7% (13/149) during a second round, 6.9% (3/43) during a third. No association was found with age, diabetes or back pain history. Most cases occurred shortly after injection; all were self-limited or resolved with a single dose of ketorolac. Conclusions: This single-center, retrospective analysis suggests that intralesional collagenase injections for Peyronie's disease may cause acute lower back pain in up to 6% of patients. Patients may benefit from counseling regarding this risk. Incidence rises with additional rounds of treatment. Prospective safety data regarding >8 injections do not exist. No patient had long-term sequelae of back pain.

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“…Greear et al review these complications and provide a framework for how to approach the patient presenting with a post-CCH complication [5]. Amighi et al describe an alternative injection protocol, termed the "fan technique," which appears to reduce procedural morbidity, and the authors propose a hematoma classification system, which may simplify the effort to compare outcomes across clinicians and institutions [6].…”

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confidence: 99%

Peyronie’s disease in contemporary urological practice

Mills

Eleswarapu

2019

World J Urol

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A modified technique for intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease results in reduced procedural morbidity using a standardized hematoma classification rubric

Cited by 16 publications

References 20 publications

Intralesional collagenase Clostridium histolyticum for acute phase Peyronie’s disease: a single-center, retrospective cohort study

Intralesional collagenase Clostridium histolyticum for acute phase Peyronie’s disease: a single-center, retrospective cohort study

Acute Lower Back Pain after Intralesional Injection of Collagenase Clostridium histolyticum for Peyronie’s Disease

Peyronie’s disease in contemporary urological practice

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