Sildenafil 25 mg ODT + Collagenase Clostridium histolyticum vs Collagenase Clostridium histolyticum Alone for the Management of Peyronie’s Disease: A Matched-Pair Comparison Analysis
Andrea Cocci MD, PhD; Gianmartin Cito MD; Daniele Urzì MD; Andrea Minervini MD; Fabrizio Di Maida MD; Francesco Sessa MD; Andrea Mari MD; Riccardo Campi MD; Marco Falcone MD; Marco Capece MD; Girolamo Morelli MD; Giovanni Cacciamani MD; Michele Rizzo MD; Chiara Polito MD; Bruno Giammusso MD; Giuseppe Morgia MD; Paolo Verze MD; Andrea Salonia MD, PhD; Tommaso Cai MD; Vincenzo Mirone MD; Nicola Mondaini MD; Giorgio Ivan Russo MD, PhD
FIRST PUBLISHED: September 20, 2018 – The Journal of Sexual Medicine
DOI: https://doi.org/10.1016/j.jsxm.2018.08.012
Introduction
Experts have not reached a consensus on the best ways to manage Peyronie’s disease. Currently, intralesional injection therapy and surgery have been proven effective.
Intralesional collagenase Clostridium histolyticum (CCH) is the first drug approved by the U.S. Food and Drug Administration (FDA) to treat Peyronie’s disease. It has recently been licensed in Europe and the United Kingdom. CCH can reduce the plaques associated with Peyronie’s disease without damaging surrounding tissue.
CCH works by selectively degrading collagen types I and III in connective tissues. Past studies have shown that 50% to 60% of men using CCH had a clinically significant improvement in curvature, with a mean reduction in curvature between 30% and 40%.
Experts have questioned the effectiveness of phosphodiesterase type 5 (PDE5) inhibitors in the management of Peyronie’s disease. The current study examined the role of sildenafil 25 mg film formulation b.i.d. in reducing curvature in men with Peyronie’s disease after treatment of CCH.
Materials and Methods
This was a prospective, non-randomized, open-label clinical study of 161 men with Peyronie’s disease who were treated with sildenafil 25 mg film formulation (S25 b.i.d.) plus CCH or with CCH alone between April 2017 and April 2018.
The participants had either dorsal or lateral penile curvature greater than 30 degrees but less than 90 degrees.
Following CCH injections, patients were instructed to model and stretch the penis between injections and to use vacuum therapy.
The sildenafil was administered once in the morning and once in the evening, 30 minutes before a modeling session.
The men completed both the International Index of Erectile Function (IIEF-15) and Peyronie’s Disease Questionnaires (PDQ) at baseline and following completion of treatment.
Curvature was measured via ultrasonography after an erection was induced with an intracavernous injection of prostaglandin E1.
Using 1:1 propensity-score matching, fifty participants were divided into two groups:
• Group A received S25 b.i.d. plus CCH.
• Group B received CCH alone.
Results
Highlights of the results are in the following table:
| Group A S25 + CCH N=25 |
Group B CCH Alone N=25 |
|
| Mean age | 49.4 years | 50.32 years |
| Mean baseline curvature | 51.6 degrees | 49.2 degrees |
| Mean change in curvature after treatment | -25.6 degrees* | -17.4 degrees* |
| Mean change in IIEF-15 score after treatment (higher is better) |
9.24* | 7.8* |
| Mean change in PDQ – psychosexual symptoms (lower is better) |
-2.12 | -2.44 |
| Mean change in PDQ – penile pain (lower is better) |
-0.88 | -1.2 |
| Mean change in PDQ – symptom bother (lower is better) |
-5.84 | -4.16 |
*Difference is statistically significant
Overall, 74% of patients experienced curvature improvements of at least 20 degrees. The median percentage penile improvement for the entire group was 47.26%
The rate of global satisfaction was 70.83% in group A and 84.0% in Group B.
Discussion
Several limitations were acknowledged.
- The therapy was not randomized
- The correct use of penile modeling was not verified
- The cohort size was small
Further research is needed to confirm the study findings. Other studies might focus on the long-term effects of CCH therapy, its use in patients with ventral penile curvature or calcified plaque, and predictors of optimal treatment success.
“We demonstrated that combination therapy was superior than CCH alone in terms of penile curvature and [erectile dysfunction] improvement,” the authors wrote.