Background

Peyronie’s disease (PD) is a connective tissue disorder that can result in penile deformities through the buildup of plaque, creating abnormalities such as curvatures of the penis in any direction. The reported prevalence of PD varies greatly, between 0.4-20.3%. Ventral (downward) curvatures demonstrate much lower rates (11-17% of all PD cases) than dorsal (upward) or lateral (sideward) curvatures. The common concern with reversing ventral curvatures is interference with the urinary system, so finding effective and safe ways to treat men with ventral PD curvatures is imperative to providing care.

Collagenase Clostridium histolyticum (CCH) injections to date are the only therapy approved by the U.S. Food and Drug Administration for treating PD, however, this was based on a study that excluded ventral curves.

Methods

Five hundred and sixty (560) men with PD were included in this study. Of these, 85 had ventral curvatures, and 457 had nonventral curvatures. All patients were treated with CCH injections, and the exact procedure evolved over time as data was collected. As of February 2023, the protocol includes injections administered on back-to-back days,  nightly sildenafil or tadalafil for six weeks, and penile wraps for two-seven days, depending on day two findings.

Between 2014 and 2019, assessments were measured at baseline and after at least 6 weeks, after the 2^nd and 4^th injections. Beyond 2019, assessments were recorded at baseline and after at least 6 weeks from each injection series if possible. Questionnaires used were the Peyronie’s Disease Questionnaire (PDQ), the International Index of Erectile Function (IIEF), and a survey with several questions regarding adverse effects and satisfaction.

Findings

The average penile length was longer in the ventral group, with a lower PDQ score (lower score = fewer symptoms/better outcomes). Additionally, the median baseline curvature was 60* for the ventral group, and 65* for the nonventral group. Penile traction devices were used for 46.6% of ventral cases, and 36% of nonventral cases. These are typically used to help straighten the penis.

There was a 44.7% reduction of curvature for the ventral group (85 men), and a 33.6% reduction for the nonventral group (475 men). Overall, 73.9% of the ventral group and 82.6% of the nonventral group found these improvements to be meaningful.

With regard to adverse effects, hematomas were found in 50% of ventral cases, and 37.2% of nonventral cases, with no significant difference between groups for bruising and popping sensations. Additionally, no urethral injuries or other urinary-related effects were observed or reported.

Interpretation

It should be noted that dorsal and ventral curvatures tend to have larger overall curvatures than lateral, which may skew results. The management of dorsal curvatures has also become significantly easier over time, which may also skew results, as those prior to 2020 may present less improvement than those after.

Despite the observational design, lack of complete data, and single supervising surgeon, this is the largest study to date that researches the use of CCH injections for ventral curvatures. Additionally, the prospective nature of this study allows for heterogeneous data from protocol evolution.

Conclusion

CCH injections appear generally safe for use on PD patients with ventral curvatures, as well as at least as effective as when used for dorsal and lateral curvatures. Additionally, researchers note that patients with ventral curvatures who completed treatment saw significantly greater improvements than those who did not (78.8% vs. 73.9%). It’s recommended that CCH injections be considered a viable treatment option.

References:

• Larson, H., Savage, J., Brearton, K., Warner, R., Ziegelmann, M., Kohler, T., & Trost, L. (2023). Outcomes of collagenase clostridium histolyticum in men with ventral curvatures: An updated series. The Journal of Sexual Medicine, 21(2), 169–174. https://doi.org/10.1093/jsxmed/qdad167