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JU INSIGHT Acute Lower Back Pain after Intralesional Injection of Collagenase Clostridium histolyticum for Peyronie's Disease
By: John T. Sigalos, MD; Michelle K. Li, BA; Dar A. Yoffe, BS; Neilufar Modiri, BA; Ming-Yeah Y. Hu, BS; Dyvon T. Walker, MD; Thomas W. Gaither, MD; Alvaro Santamaria, MD; Keith V. Regets, PA-C; Sriram V. Eleswarapu, MD, PhD; Jesse N. Mills, MD | Posted on: 01 Oct 2022
Sigalos JT, Li MK, Yoffe DA, et al., Acute lower back pain after intralesional injection of collagenase clostridium histolyticum for Peyronie’s disease. J Urol. 2022;208(4)872-877.
Study Need and Importance
In spring of 2021, the U.S. Food and Drug Administration safety label for collagenase Clostridium histolyticum was changed to include acute onset lower back pain as a potential adverse event when used for intralesional treatment of Peyronie’s disease. While this adverse event was not seen in the original IMPRESS trials, post-marketing evaluation of intralesional collagenase in the nonclinical trial setting uncovered reports of postinjection acute lower back pain. To date, there has been no published work describing this phenomenon.
Table. Demographic and clinical correlates of acute lower back pain after intralesional injection of collagenase C. histolyticum for Peyronie’s disease
| Back Pain (n=19) | No Back Pain (n=311) | p Value | |
|---|---|---|---|
| Mean yrs (SD) | 60.2 (12.4) | 58.9 (11.1) | 0.62 |
| Race, no. (%) | |||
| American Indian/Alaska Native | 0 | 2 (0.6) | 0.90 |
| Asian | 0 | 4 (1.0) | |
| Black | 0 | 5 (2.0) | |
| Other | 1 (5.0) | 23 (7.0) | |
| White | 15 (79) | 217 (70) | |
| Refused/unknown | 3 (16) | 60 (19) | |
| Ethnicity, no. (%) | |||
| Hispanic/Latino | 1 (5.0) | 16 (5.0) | 0.98 |
| Diabetes mellitus, no. (%) | |||
| Yes | 2 (11) | 31 (10) | 0.94 |
| Hypertension, no. (%) | |||
| Yes | 5 (26) | 74 (24) | 0.80 |
| Hyperlipidemia, no. (%) | |||
| Yes | 6 (32) | 72 (23) | 0.40 |
| BMI, no. (%) | |||
| Normal | 12 (63) | 179 (58) | 0.51 |
| Overweight | 6 (32) | 86 (28) | |
| Obese | 1 (5.0) | 46 (15) | |
| History of Dupuytren’s, no. (%) | |||
| Yes | 1 (5.0) | 14 (5.0) | 0.88 |
| Concomitant erectile dysfunction, no. (%) | |||
| Yes | 14 (74) | 173 (56) | 0.12 |
| Smoking history, no. (%) | |||
| Never | 13 (68) | 222 (71) | 0.61 |
| Former | 6 (32) | 78 (25) | |
| Current | 0 | 11 (4.0) | |
| Initial degree of curvature, mean(SD) | 51.0 (15.0) | 44.4 (15.2) | 0.07 |
| Any genitourinary surgery, no. (%) | |||
| Yes | 5 (26) | 57 (18) | 0.39 |
| Duration of Peyronie’s disease, median mos (IQR) | 12 (9-18) | 12 (6-36) | 0.30 |
| History of back pain, no. (%) | |||
| Yes | 5 (26) | 100 (32) | 0.60 |
| History of back pain surgery, no. (%) | |||
| Yes | 0 | 34 (11) | 0.13 |
What We Found
Of our cohort 6% experienced back pain with intralesional treatment of collagenase C. histolyticum for Peyronie’s disease. Prevalence of this side effect was 1.3% during the first course of 8 injections. Back pain incidence increased to 8.7% if patients received a second course of treatment. When investigating potential risk factors for back pain post injection, we found no statistically significant relationship with comorbidities, lifestyle factors, or history of back pain or surgery (see Table). All cases of back pain self-resolved within 20 minutes or abated rapidly with a single injection of ketorolac. There were no cases of long-term back pain related to treatment.
Limitations
This is a retrospective review of a single high-volume center in an affluent geographic area with mostly commercial insurance and may not be generalizable to all populations. Sample size was sufficient to make conclusions regarding acute lower back pain incidence; however, the low rate of back pain limits definitive conclusions about potential predictive factors.
Interpretation for Patient Care
Men who elect intralesional collagenase C. histolyticum for the treatment of Peyronie’s disease should be aware of this potential adverse event. Additionally, providers should be aware if providing a second course of treatment off-label that the incidence of acute lower back pain increases.
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