Sildenafil 25 mg ODT + Collagenase Clostridium hystoliticum vs Collagenase Clostridium hystoliticum Alone for the Management of Peyronie’s Disease: A Matched-Pair Comparison Analysis
Authors: Cocci Andrea , Cito Gianmartin , Urzì Daniele , Minervini Andrea , Di Maida Fabrizio , Sessa Francesco , Mari Andrea , Campi Riccardo , Falcone Marco , Capece Marco , Morelli Girolamo , Cacciamani Giovanni , Rizzo Michele , Polito Chiara , Giammusso Bruno , Morgia Giuseppe , Verze Paolo , Salonia Andrea , Cai Tommaso , Mirone Vincenzo , Mondaini Nicola , Russo Giorgio Ivan 
Published: September 2018

Abstract

Introduction
The effectiveness of phosphodiesterase type 5 (PDE5) inhibitors over the conservative management of Peyronie’s disease (PD) has been widely questioned.

Aim
To determine the role of sildenafil 25 mg film formulation twice a day (S25 b.i.d.) in the improvement of curvature after treatment of collagenase of Clostridium hystoliticum (CCH) in penile curvature owing to PD.

Methods
From April 2017 to April 2018, 161 consecutive patients were treated with S25 b.i.d. + CCH or CCH alone. Adjustment variables consisted of age, penile curvature, and the 15-question International Index of Erectile Function (IIEF-15) questionnaire at baseline using 1:1 propensity-score matching. Overall, 50 patients were considered subdivided into the following: 25 patients who received S25 b.i.d. + CCH (group A) and 25 who received CCH alone (group B). Patients received CCH injection using a shortened protocol and vacuum device in both groups.

Main Outcome Measure
The primary outcome of the study was the change in penile curvature after treatment, and secondary outcomes were the change in sexual function (IIEF-15) and in the Peyronie’s Disease Questionnaire (PDQ) and its subscores, PDQ-PS (psychosexual symptoms), PDQ-PP (penile pain), and PDQ-SB (symptom bother).

Results
Overall, mean penile curvature was 47.0° (SD 21.88), the mean IIEF-EF (erectile function) was 23.56 (SD 4.10), and the mean PDQ was 27.06 (SD 13.55). After the treatment, we observed a mean change for penile curvature of 25.6 (SD 9.05) in group A and –25.6 (SD 9.7) in group B (P &lt; .01), for IIEF-EF of 2.28 (SD 2.33) in group A and 1.36 (SD 1.77) in group B (P = .03), for PDQ-PS of –3.04 (SD 2.95) in group A and of –2.12 (SD 2.06) in group B (P = .11), for PDQ-PP of –1.0 (SD 4.48) in group A and of –0.88 (SD 2.04) in group B (P = .60), for PDQ-SB of –5.84 (SD 4.58) in group A and of –4.16 (SD 4.45) in group B (P = .60), and for Female Sexual Function Index of 3.8 (SD 2.45) in group A and of 2.72 (SD 2.28) in group B (P = .14). We found a rate of global satisfaction of 70.83% in group A and of 84.0% in group B (P = .27).

Clinical Implications
Addition of S25 b.i.d. to CCH is superior to CCH alone for improving penile curvature and erectile function.

Strength & Limitations
This is the first study comparing sildenafil + CCH vs CCH alone for the treatment of PD. Lack of randomization and direct verification of appropriate use of penile modeling could be considered limitations.

Conclusion
In this study, combination therapy was superior in terms of penile curvature and erectile dysfunction improvement.