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Novel nomogram predicting the probability of penile curvature improvement in patients Collagenase Clostridium Histolyticum (CCH-Xiapex®) using a new shortened protocol

Cocci, A1; Russo, GI2; Cito, G1; Capece, M3; Falcone, M4; Timpano, M4; Cacciamani, G5; Polloni, G6; Giammusso, B2; Verze, P3; Arcaniolo, D3; Mirone, V3; Giubilei, G7; Rizzo, M8; Mondaini, N9

1: Careggi Hospital, Italy; 2: University of Catania, Italy; 3: University of Naples, Italy; 4: University of Turin, Italy; 5: University of Verona, Italy; 6: Psyco-sexologist, Psycosexology, Florence, Italy; 7: Leonardo da Vinci Hospital, Empoli, Italy; 8: University of Trieste, Italy; 9: Santa Maria Annunziata Hospital, Florence, Italy

Objectives: Peyronie’s disease (PD) has a devastating effect on patients and their partners. Several non-surgical therapies have been tried in PD, but their efficacy remains questionable. Collagenase clostridium histolyticum (CCH- Xiapex®) is the only licensed product for treatment of PD. The aim of our study is to evaluate the safety and efficacy after the first injection of Xiapex and also to build-up a nomogram able to identify predictive factors of penile curvature (PC) improvement (-20.0 degrees).

Materials & Methods: 135 patients were enrolled, evaluating by history, examination, ICI test. They underwent pre and post treatment evaluation of the angle of PC, IIEF-15, Global Assessment of PD,PD questionnaires(PDQ),performed at baseline and after the first injection. Patients with calcified plaque and ventral curvature were excluded. All patients had a treatment with CCH using a new shortened protocol of three injections at 4 weekly intervals, with an intra-lesional injection of CCH (0.9mg) into the plaque at the point of maximal curvature. Patients were instructed to perform a stretching for 4 weeks. Partners were evaluated with Female Sexual Function Index(FSFI)questionnaire.

Results: All patients completed the study protocol. Median age was 56.0 (IQR:45.0,65.0), median partner’s age 53.0 (IQR:43.0-56.0), median PC was 30.0 (IQR:30.0,60.0). After the final follow-up, we observed a median change for PC of -20.0 [IQR:17.5,20.0;p=0.00), for IIEF-EF of -1.0 (IQR:-2.0,-1.0;p=0.00), for IIEF-OF of -0.5 (IQR:-1.0,-0.5;p=0.00), for IIEF-SD of -1.0 (IQR:-1.0,-0.5;p=0.00), for IIEF-IS of -1.0 (IQR:-1.5,-1.0;p=0.00), for IIEF-OS of 1.0 (IQR:-1.0,-0.5;p=0.00), for PDQ-symptoms of 2.5 (IQR:2.0,2.5;p=0.00), for PDQ-pain of 1.0 (IQR:1.0,1.5;p=0.00), for PDQ-bother of 3.5 (IQR:3.0,4.5;p=0.00) and for FSFI of 4.0 (IQR:-4.0,-3.5;p=0.00). Overall median satisfaction was 8.0 (IQR:7.0-9.0). Ecchymosis were in 108 patients (80.0%) and haematoma in 17 (12.6%). Figure 1 showed the multivariable effect of each variable on the probability of PC improvement after treatment in the form of a nomogram. The c-index for the model was 0.93.

Conclusions: In this large single-arm multicenter clinical study, we observed clinical improvement of PC, patients’ and partners’ sexual function after treatment with CCH for PD. This nomogram can also be useful for patients in order to predict results after CCH treatment.

Fig. 1 – Novel nomogram predicting the probability of penile curvature improvement (-20 degrees) in patients CCH injections.

Disclosure:

Work supported by industry: no.

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