The impact of collagenase clostridium histolyticum (CCH) priming on surgical outcomes in Peyronie’s disease: a retrospective cohort study
Highlight box
Key findings
• Prior collagenase clostridium histolyticum (CCH) exposure did not affect curvature correction after tunica albuginea plication.
• Both groups achieved >90% curvature reduction with comparable postoperative curvature.
• Patient satisfaction and revision surgery rates were similar regardless of prior CCH use.
What is known and what is new?
• Tunical plication is an effective surgical treatment for stable Peyronie’s disease, and CCH is widely used as a nonsurgical option
• This study demonstrates that prior CCH treatment does not compromise surgical outcomes following plication, despite theoretical concerns regarding tunical integrity.
What is the implication, and what should change now?
• Prior CCH exposure should not deter clinicians from offering tunica albuginea plication when indicated.
• Patients can be counseled that surgical outcomes, including curvature correction and satisfaction, are comparable regardless of prior intralesional therapy.
Introduction
Peyronie’s disease (PD) is an acquired wound-healing disorder of the tunica albuginea in which microtrauma triggers persistent scar formation and plaque development (1). Symptoms vary by disease phase. The active phase is marked by penile pain and progressive curvature, while the stable phase is characterized by resolution of pain and stabilization of deformity (2). Erectile dysfunction is commonly comorbid and can occur in either phase, often compounding the sexual dysfunction (3). PD also carries a substantial psychosocial burden, with negative effects on quality of life and intimate relationships, and it is frequently associated with depressive symptoms (4,5). Current American Urological Association (AUA) guidelines emphasize individualized treatment through shared decision-making to align management with patient goals (2). The central clinical goal is to reduce curvature and restore sexual function, which can ease patient distress and improve overall well-being.
AUA guidelines stratify treatment by disease phase, recommending nonsteroidal anti-inflammatory drugs during the active phase. During the stable phase, surgical management or intralesional therapy, such as collagenase clostridium histolyticum (CCH), is recommended, along with consideration of adjunct therapies (2). CCH is one intralesional treatment used for PD, along with verapamil and interferon beta. Among these, CCH is currently the only Food and Drug Administration (FDA)-approved intralesional therapy. CCH works by enzymatically degrading collagen within the plaque and is a key option for those who do not wish for surgery. Surgery remains the gold standard for reduction in curvature. Tunical plication is a standard reconstructive option for stable PD when rigidity is adequate for intercourse. While incision & grafting or penile prosthesis placement are more commonly utilized for severe or complex deformity in addition to for erectile dysfunction that limits intercourse.
Multiple factors influence outcomes after tunical plication, including operative technique and potentially incision location (6,7). Reported outcomes after plication vary across studies with many not reporting subgroup outcomes in men with prior CCH treatment (8). As CCH use has increased, a growing number of men presenting for plication have already received intralesional therapy. As a result, limited evidence defines whether prior CCH exposure changes plication outcomes, including complication rates, operative complexity, and need for revision. Patient satisfaction after CCH is typically high in published series, so this question matters for men with persistent, function-limiting deformity after non-surgical management (9,10).
In this study, we evaluated outcomes after tunica albuginea plication in men with PD with and without prior exposure to CCH. Using a retrospective cohort from our institution, we compared perioperative complications, postoperative curvature outcomes, and rates of revision surgery between groups. Defining whether prior CCH treatment influences plication outcomes will improve preoperative counseling and shared decision-making for patients who are considering intralesional therapy and later surgical correction. We present this article in accordance with the STROBE reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-2026-0383/rc).
Methods
Study design and population
We conducted a single-center, retrospective cohort study at Baylor College of Medicine. Male patients aged 18 years or older who presented with a diagnosis of PD between January 2015 and July 2024 were eligible for inclusion. Patient records were identified using International Classification of Diseases, 10th Revision (ICD-10) codes for PD and procedure codes for CCH injections and tunica albuginea plication. Curvature severity was categorized as follows: grade 1 for curvature less than 30°, grade 2 for curvature between 30° and 60°, and grade 3 for curvature greater than 60°. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board (No. H-56475) and informed consent was obtained from all individual participants.
Outcomes
We extracted demographic variables such as age, race, and comorbidities, along with disease characteristics including prior treatment strategies, duration, curvature severity, and direction. For patients who underwent surgical correction, we collected data on the type of procedure, intraoperative findings, immediate postoperative outcomes, complications, and longer-term measures such as curvature correction, and patient satisfaction.
Statistical analysis
Data was analyzed using STATA 15.0. Descriptive statistics were used to summarize demographic and baseline clinical characteristics and to compare these with end-of-treatment outcomes. Continuous variables were analyzed using t-tests, while categorical variables were evaluated using Chi-squared or Fisher’s exact tests when appropriate.
Results
Study population
A total of 926 patients with PD were screened for tunica albuginea plication and prior treatment with CCH; 322 (35%) patients received intralesional CCH, including 8 injections as part of 4 cycles; and 604 (65%) did not. Ultimately, 25 (7.8%) patients in the CCH group and 34 (5.6%) patients in the no CCH group proceeded with plication. Baseline characteristics were similar between groups with respect to body mass index (BMI) and race. The mean BMI was 27.8±4.9 kg/m2 in the CCH group and 26.8±3.6 kg/m2 non-CCH group (P=0.39). Patients who received CCH were older, with a mean age of 57.3±8.9 years compared to 49.4±17.7 in the non-CCH group (P=0.02), detailed further in Table 1.
Table 1
| Characteristics | No CCH exposure (n=34) | CCH exposure (n=25) | P value |
|---|---|---|---|
| Age (years) | 49.4±17.7 | 57.3±8.90) | 0.02* |
| BMI (kg/m2) | 26.8±3.6 | 27.8±4.9 | 0.39 |
| Race/ethnicity | |||
| White (non-Hispanic/non-Latino) | 29 (85.3) | 23 (92.0) | |
| White (Hispanic or Latino) | 1 (2.9) | 0 (0.0) | |
| Black | 3 (8.8) | 1 (4.0) | |
| Asian | 0 (0.0) | 1 (4.0) | |
| Other/unknown | 1 (2.9) | 0 (0.0) |
Data are presented as mean ± standard deviation or n (%). Continuous variables compared with t-tests. Statistical significance is P<0.05. *, P value significant. BMI, body mass index; CCH, collagenase clostridium histolyticum.
Baseline comorbidities were largely comparable between the two cohorts. Most conditions including hypertension, hyperlipidemia, diabetes, depression, anxiety, and hypogonadism were similar between patients who received CCH and those who did not (P>0.05). The CCH-treated group also demonstrated a higher prevalence of positive smoking history and testosterone therapy use compared with patients who did not receive CCH (P<0.05). Erectile dysfunction was more common in the prior CCH cohort (80.0% vs. 58.8%) but did not reach statistical significance (P=0.08). All baseline comorbidities by cohort are summarized in Table 2.
Table 2
| Comorbidities | No prior CCH (n=34), n (%) | Prior CCH (n=25), n (%) | P value |
|---|---|---|---|
| Hypertension | 10 (29.4) | 9(36.0) | 0.47 |
| Hyperlipidemia | 5 (14.7) | 6 (24.0) | 0.36 |
| Myocardial infarction | 1 (2.9) | 0 (0.0) | >0.99 |
| Congestive heart failure | 1 (2.9) | 0 (0.0) | >0.99 |
| Peripheral vascular disease | 4 (11.8) | 0 (0.0) | 0.13 |
| Stroke/transient ischemic attack | 2 (5.9) | 1 (4.0) | >0.99 |
| Asthma/chronic obstructive pulmonary disease | 3 (8.8) | 2 (8.0) | >0.99 |
| Chronic kidney disease | 1 (2.9) | 1 (4.0) | >0.99 |
| Chronic liver disease | 2 (5.9) | 2 (8.0) | >0.99 |
| Diabetes | 3 (8.8) | 3 (12.0) | 0.69 |
| History of solid tumor | 3 (8.8) | 6 (24.0) | 0.14 |
| Leukemia | 1 (2.9) | 0 (0.0) | >0.99 |
| AIDS | 1 (2.9) | 0 (0.0) | >0.99 |
| Depression | 8 (23.5) | 5 (20.0) | 0.74 |
| Anxiety | 7 (20.6) | 5 (20.0) | 0.95 |
| Rheumatic disease | 1 (2.9) | 1 (4.0) | >0.99 |
| Smoking history | 8 (23.5) | 12 (48.0) | 0.050 |
| Anemia | 0 (0.0) | 1 (4.0) | 0.47 |
| Erectile dysfunction | 20 (58.8) | 20 (80.0) | 0.08 |
| Hypogonadism | 18 (55.9) | 16 (64.0) | 0.53 |
| TRT use | 10 (31.2) | 16 (64.0) | 0.01* |
Categorical variables compared with Chi-squared tests or Fisher’s exact tests, as appropriate. Statistical significance is P<0.05. *, P value significant. AIDS, acquired immunodeficiency syndrome; CCH, collagenase clostridium histolyticum; TRT, testosterone replacement therapy.
Pre- and postoperative curvature outcomes
Preoperative curvature was comparable between groups (no CCH: 51.2°±17.5°, CCH: 56.6°±19.1°, P=0.27). Both cohorts experienced substantial curvature improvement following plication, with no statistically significant differences in the magnitude of correction. Mean curvature change was 49.9°±19.4° in the non-CCH group and 52.0°±20.4° in the CCH group (P=0.71). Postoperative curvature also did not differ significantly (no CCH: 3.0°±5.9°, CCH: 4.6°±7.6°, P=0.58). Curvature details and the postoperative curvature grade breakdown by cohort are summarized in Table 3.
Table 3
| Curvature | No prior CCH (n=34) | Prior CCH (n=25) | P value |
|---|---|---|---|
| Pre-op (°) | 51.2±17.5 | 56.6±19.1 | 0.27 |
| Pre-op curvature grades | – | ||
| Grade I (≤30°) | 2 (5.9) | 0 (0.0) | |
| Grade II (30–60°) | 25(73.5) | 15 (60.0) | |
| Grade III (>60°) | 7 (20.6) | 10 (40.0) | |
| Post-op (°) | 3.0±6.0 | 4.6±7.6 | 0.43 |
| Post-op curvature grades | – | ||
| Grade I (≤30°) | 30 (100.0) | 25 (100.0) | |
| Grade II (30–60°) | 0 (0.0) | 0 (0.0) | |
| Grade III (>60°) | 0 (0.0) | 0 (0.0) | |
| Pre-op–post-op (°) | 49.9±19.4 | 52±20.4 | 0.71 |
| Post-op (% change) | 93.3±14.3 | 91.0±16.1 | 0.58 |
Data are presented as mean ± standard deviation or n (%). Includes only patients with pre- and post-plication curvatures. Continuous variables compared with t-tests. Statistical significance is P<0.05. *, P value significant. CCH, collagenase clostridium histolyticum.
Surgical complications and recovery
As shown in Table 4, Intraoperative complications did not occur in either group. Complications in the 30 days following discharge were more frequent in the CCH cohort (20.0% vs. 2.9%, P=0.08). Complications between 30 to 90 following discharge did not occur in either group. All complications were minor in nature and classified as Clavien-Dindo grade I, including wound complication (n=5) and urinary catheterization (n=2).
Table 4
| Outcomes | No prior CCH | Prior CCH | P value (Fisher’s exact) |
|---|---|---|---|
| Intraoperative complication, n/N (%) | 0/34 (0.0) | 0/25 (0.0) | – |
| 30-day complication, n/N (%) | 1/34 (2.9) | 5/25 (20.0) | 0.08 |
| 90-day complication, n/N (%) | 0/33 (0.0) | 0/25 (0.0) | – |
| Any complication, n/N (%) | 1/34 (2.9) | 5/25 (20.0) | 0.08 |
| Need for revision, n/N (%) | 2/34 (5.9) | 3/25 (12.0) | 0.53 |
| Surgical revision, n/N (%) | 2/2 (100.0) | 3/3 (100.0) | – |
| Medical revision, n/N (%) | 0/0 (0.0) | 0/0 (0.0) | – |
| Patient satisfaction, n/N (%) | 21/24 (87.5) | 21/23 (91.3) | >0.99 |
Denominators vary due to missing follow-up data. Any complication counts unique patients with an in-hospital or 30-day event (patients counted once). Compared with Fisher’s exact test. Statistical significance is P<0.05. CCH, collagenase clostridium histolyticum.
Patient-reported outcomes and need for revision
Patient satisfaction rates were high and nearly identical between groups (no CCH: 87.5%, CCH: 91.3%, P>0.99). Although patient satisfaction was not noted in 29.4% of non-CCH cohort which could have impacted the true rate of patient satisfaction. The need for surgical revision was comparable between groups (12.0% vs. 5.8%, P=0.53) with 100% of these revisions constituting surgical revisions.
Discussion
This retrospective study of 59 patients with PD who underwent penile plication examined whether prior CCH treatment affects surgical outcomes. Our principal findings demonstrate that while CCH-pretreated patients were older (57.3 vs. 49.4 years, P=0.02), both groups achieved significant and comparable curvature correction, with mean reductions exceeding 90% and final curvatures of 3.0° and 4.6° respectively (P=0.43). However, CCH-pretreated patients trended toward higher 30-day complications (20.0% vs. 2.9%, P=0.08), all of which were minor (Clavien-Dindo grade I), and similar revision surgery rates (12.0% vs. 5.9%, P=0.53). Patient satisfaction remained high and equivalent between groups (91.3% vs. 87.5%). The lack of effect in the rate of revision surgery following CCH pretreatment is comparable to revision rates reported in the plication literature, which typically range from 0–10% (2,11-13).
Baseline differences between cohorts may reflect patient selection in clinical practice. CCH-pretreated patients were older and demonstrated significantly higher rates of testosterone replacement therapy use (64.0% vs. 31.2%, P=0.01) and smoking history (48.0% vs. 23.5%, P=0.050), with a trend toward higher erectile dysfunction prevalence (80.0% vs. 58.8%, P=0.08). This pattern may suggest that CCH was offered to patients seeking initial conservative management, though the Investigation of Maximal Peyronie’s Reduction Efficacy and Safety Studies (IMPRESS) trials did not specifically select for such characteristics (11,12). Following FDA approval in 2013, CCH became the only approved pharmacologic therapy for PD and has been utilized in clinical practice for men wishing to defer or avoid surgery (13,14). The higher erectile dysfunction rate in CCH-pretreated patients may reflect either disease progression during treatment, patient selection factors, or the natural history of Peyronie’s in this population (15,16).
The equivalent curvature correction achieved in both groups provides reassurance that prior CCH exposure does not compromise plication effectiveness. Preoperative curvature was similar (51.4° vs. 56.6°, P=0.27), with comparable distributions of moderate deformity (30–60° in 73.5% vs. 60.0%). Both groups achieved excellent correction with mean reductions of 49.9° and 52.0° respectively, representing a similar reduction in curvature (93.3% vs.91%, P=0.59). This finding is clinically important as it confirms that CCH treatment does not eliminate surgery as a highly effective subsequent option. The equivalent outcomes are notable given that plication relies on precise suture placement and tunical integrity, and CCH-induced collagen degradation could theoretically compromise tissue strength. While no studies have specifically examined tunical biomechanical properties after CCH treatment, our results suggest sufficient tissue healing occurs between CCH completion and surgery to permit effective surgical correction.
The comparable revision rates observed between groups (12.0% vs. 5.9%, P=0.53) further support that prior CCH treatment does not appear to limit or adversely impact subsequent surgical management when additional correction is pursued. These findings are consistent with existing literature, in which revision rates following plication are generally reported to be below 10% (1,2,17). However, these results should be interpreted with caution given the small sample size, with only 3 revisions among 25 CCH-pretreated patients and 2 revisions among 34 non-CCH patients. This corresponds to an absolute difference of approximately 6%, representing just one additional revision in the CCH group. While not statistically significant, larger studies are needed to better characterize this association.
Several factors may contribute to revision risk. It is possible that CCH-induced collagen degradation could affect long-term tunical integrity at suture sites, though this remains speculative and warrants further investigation. Additionally, patients who fail CCH may represent a cohort with more complex disease, such as greater plaque burden or altered tissue characteristics, which could predispose to both CCH failure and increased surgical difficulty. Differences in baseline characteristics, including higher rates of erectile dysfunction and smoking in the CCH group, may also contribute to impaired wound healing. Notably, high satisfaction rates (91.3% vs. 87.5%) suggest patients may value attempting conservative management first, even when it ultimately requires escalation to surgical correction.
For the practicing andrologist, our findings carry important clinical implications. CCH remains appropriate for men seeking to avoid surgery, particularly those with moderate curvature and preserved erectile function. Our data confirm prior CCH does not preclude meaningful curvature correction with subsequent plication. Men considering CCH should understand that if plication ultimately becomes necessary, the likelihood of requiring a second procedure may not be reduced. Patient selection becomes critical--men with severe curvature (>60°) or complex deformities may benefit from proceeding directly to surgery, as these factors have been shown to be predictive of surgical intervention after CCH failure (21). While plication remains feasible after CCH, additional preoperative counseling in this population may be warranted to set expectations regarding postoperative recovery, the possibility of revision surgery and the planned follow-up schedule.
A notable strength of this study is the use of a large institutional screening cohort of 926 patients with PD, which enabled characterization of the real-world progression from CCH therapy to surgical correction. This large denominator enhances the clinical relevance of the observed treatment pathway and provides context for the comparative surgical outcomes analysis.
This study has several important limitations. Although the overall screening cohort was large, the surgical cohort consisted of only 59 patients, limiting statistical power and the ability to draw definitive conclusions, particularly with respect to revision surgery, where few events occurred. Post-hoc power analysis revealed that the study was substantially underpowered for most endpoints (achieved power 6.8–60.3%). The retrospective design introduces inherent selection bias, as treatment decisions reflected physician judgment and patient preference rather than randomization. Furthermore, baseline differences between cohorts, including age, smoking history, testosterone replacement therapy use, and erectile dysfunction prevalence, may have influenced surgical outcomes. Given the limited sample size and number of events, multivariable adjustment was not feasible, and residual confounding cannot be excluded.
Additional limitations relate to the available clinical data. We lacked standardized information regarding CCH treatment protocols, including the number of injection cycles completed, degree of response to CCH, and the interval between CCH completion and surgery, all of which may have influenced outcomes. We were also unable to characterize the specific indications for revision surgery, limiting interpretation of these events. Finally, the single-center design may limit generalizability to other practice settings, where surgeon experience and operative techniques may differ, and follow-up duration was variable with incomplete long-term patient-reported outcome data.
Conclusions
Our study quantified the proportion of men with PD who progressed from CCH therapy to tunica albuginea plication and evaluated whether prior CCH exposure was associated with differences in surgical outcomes. Within a large institutional cohort of 926 patients, only 7.8% of men treated with CCH subsequently underwent plication. Among those who underwent surgery, prior CCH exposure was not associated with statistically significant differences in curvature correction, patient satisfaction, perioperative complications, or revision surgery rates. However, given the limited size of the surgical cohort, larger studies are needed to further evaluate potential differences in revision risk and other postoperative outcomes. These findings suggest that prior CCH exposure does not appear to preclude successful plication when surgery is clinically indicated.
Acknowledgments
This work was presented at the American Urological Association National 2026 Annual Meeting.
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-2026-0383/rc
Data Sharing Statement: Available at https://tau.amegroups.com/article/view/10.21037/tau-2026-0383/dss
Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2026-0383/prf
Funding: This study was supported by
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2026-0383/coif). M.K. is a consultant at Endo Pharmaceuticals, Marius, Besins, Boston Scientific, AbbVie, Petros, Coloplast, Halozyme, Verity, and holds stock in Sprout. The other authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Institutional Review Board (No. H-56475) and informed consent was obtained from all individual participants.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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