Sildenafil 25 mg ODT + Collagenase Clostridium hystoliticum vs Collagenase Clostridium hystoliticum Alone for the Management of Peyronie's Disease: A Matched-Pair Comparison Analysis.

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

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.

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.

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).

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 < .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).

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

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.

In this study, combination therapy was superior in terms of penile curvature and erectile dysfunction improvement. Cocci A, Cito G, Urzi D, et al. Sildenafil 25 mg ODT + collagenase Clostridium hystoliticum vs collagenase Clostridium hystoliticum alone for the management of Peyronie's disease: A matched-pair comparison analysis. J Sex Med 2018;XX:XXX-XXX.

The journal of sexual medicine. 2018 Sep 20 [Epub ahead of print]

Andrea Cocci, Gianmartin Cito, Daniele Urzì, Andrea Minervini, Fabrizio Di Maida, Francesco Sessa, Andrea Mari, Riccardo Campi, Marco Falcone, Marco Capece, Girolamo Morelli, Giovanni Cacciamani, Michele Rizzo, Chiara Polito, Bruno Giammusso, Giuseppe Morgia, Paolo Verze, Andrea Salonia, Tommaso Cai, Vincenzo Mirone, Nicola Mondaini, Giorgio Ivan Russo

Department of Urology, University of Florence, Florence, Italy., Urology Section, University of Catania, Catania, Italy., Department of Urology, Molinette Hospital, University of Turin, Turin, Italy., Department of Urology, University of Naples, Naples, Italy., Cisanello Hospital, University of Pisa, Pisa, Italy., Department of Urology, University of Verona, Verona, Italy., Department of Urology, University of Trieste, Turin, Italy., Morgagni Clinic, Catania, Italy., Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy., Department of Urology, Santa Chiara Regional Hospital, Trento, Italy., Andrology Center, Villa Donatello Hospital, Florence., Urology Section, University of Catania, Catania, Italy. Electronic address: .