Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study

Andrea Cocci, GI Russo, A Salonia, G Cito, F Regis, G Polloni, G Giubilei, G Cacciamani, M Capece, M Falcone, I Greco, M Timpano, A Minervini, M Gacci, T Cai, G Garaffa, B Giammusso, D Arcaniolo, V Mirone, N Mondaini

Research output: Contribution to journalArticle

Abstract

Background: Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD). Aim: To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners’ bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center. Methods: All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections. Outcomes: International Index of Erectile Function (IIEF)–15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment. Results: Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33%) partners showed a degree of sexual dysfunction. Baseline median IIEF–15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF–total and all domains significantly improved after treatment (all P <.01). A PC mean change of 19.07 (P =.00) was measured. At the univariate linear regression analysis, IIEF–15, IIEF–erectile function, IIEF–sexual desire, and IIEF–intercourse satisfaction were positively associated with FSFI (all P ≤.03); conversely, PDQ–penile pain, PDQ–symptom bother, and post-treament penile curvature (P ≤.04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95% CI 0.02–0.11; P =.004). Global satisfaction after treatment was 89.6% (121/135). Clinical Translation: This modified CCH treatment protocol could improve both patients’ and partner's sexual function. Strength and limitations: This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account. Conclusions: The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients’ and partners’ sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716–721. © 2018 International Society for Sexual Medicine
Original languageEnglish
Pages (from-to)716-721
Number of pages6
JournalJournal of Sexual Medicine
Volume15
Issue number5
DOIs
Publication statusPublished - 2018

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Microbial Collagenase
Penile Induration
Sexual Partners
Injections
Heterosexuality
Clinical Protocols
Therapeutics
Tertiary Care Centers
Physical Examination
Linear Models
Appointments and Schedules
Placebos
Regression Analysis

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Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. / Cocci, Andrea; Russo, GI; Salonia, A; Cito, G; Regis, F; Polloni, G; Giubilei, G; Cacciamani, G; Capece, M; Falcone, M; Greco, I; Timpano, M; Minervini, A; Gacci, M; Cai, T; Garaffa, G; Giammusso, B; Arcaniolo, D; Mirone, V; Mondaini, N.

In: Journal of Sexual Medicine, Vol. 15, No. 5, 2018, p. 716-721.

Research output: Contribution to journalArticle

Cocci, A, Russo, GI, Salonia, A, Cito, G, Regis, F, Polloni, G, Giubilei, G, Cacciamani, G, Capece, M, Falcone, M, Greco, I, Timpano, M, Minervini, A, Gacci, M, Cai, T, Garaffa, G, Giammusso, B, Arcaniolo, D, Mirone, V & Mondaini, N 2018, 'Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study', Journal of Sexual Medicine, vol. 15, no. 5, pp. 716-721. https://doi.org/10.1016/j.jsxm.2018.03.084
Cocci, Andrea ; Russo, GI ; Salonia, A ; Cito, G ; Regis, F ; Polloni, G ; Giubilei, G ; Cacciamani, G ; Capece, M ; Falcone, M ; Greco, I ; Timpano, M ; Minervini, A ; Gacci, M ; Cai, T ; Garaffa, G ; Giammusso, B ; Arcaniolo, D ; Mirone, V ; Mondaini, N. / Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. In: Journal of Sexual Medicine. 2018 ; Vol. 15, No. 5. pp. 716-721.
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abstract = "Background: Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD). Aim: To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners’ bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center. Methods: All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections. Outcomes: International Index of Erectile Function (IIEF)–15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment. Results: Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33{\%}) partners showed a degree of sexual dysfunction. Baseline median IIEF–15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF–total and all domains significantly improved after treatment (all P <.01). A PC mean change of 19.07 (P =.00) was measured. At the univariate linear regression analysis, IIEF–15, IIEF–erectile function, IIEF–sexual desire, and IIEF–intercourse satisfaction were positively associated with FSFI (all P ≤.03); conversely, PDQ–penile pain, PDQ–symptom bother, and post-treament penile curvature (P ≤.04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95{\%} CI 0.02–0.11; P =.004). Global satisfaction after treatment was 89.6{\%} (121/135). Clinical Translation: This modified CCH treatment protocol could improve both patients’ and partner's sexual function. Strength and limitations: This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account. Conclusions: The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients’ and partners’ sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716–721. {\circledC} 2018 International Society for Sexual Medicine",
author = "Andrea Cocci and GI Russo and A Salonia and G Cito and F Regis and G Polloni and G Giubilei and G Cacciamani and M Capece and M Falcone and I Greco and M Timpano and A Minervini and M Gacci and T Cai and G Garaffa and B Giammusso and D Arcaniolo and V Mirone and N Mondaini",
year = "2018",
doi = "10.1016/j.jsxm.2018.03.084",
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TY - JOUR

T1 - Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study

AU - Cocci, Andrea

AU - Russo, GI

AU - Salonia, A

AU - Cito, G

AU - Regis, F

AU - Polloni, G

AU - Giubilei, G

AU - Cacciamani, G

AU - Capece, M

AU - Falcone, M

AU - Greco, I

AU - Timpano, M

AU - Minervini, A

AU - Gacci, M

AU - Cai, T

AU - Garaffa, G

AU - Giammusso, B

AU - Arcaniolo, D

AU - Mirone, V

AU - Mondaini, N

PY - 2018

Y1 - 2018

N2 - Background: Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD). Aim: To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners’ bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center. Methods: All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections. Outcomes: International Index of Erectile Function (IIEF)–15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment. Results: Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33%) partners showed a degree of sexual dysfunction. Baseline median IIEF–15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF–total and all domains significantly improved after treatment (all P <.01). A PC mean change of 19.07 (P =.00) was measured. At the univariate linear regression analysis, IIEF–15, IIEF–erectile function, IIEF–sexual desire, and IIEF–intercourse satisfaction were positively associated with FSFI (all P ≤.03); conversely, PDQ–penile pain, PDQ–symptom bother, and post-treament penile curvature (P ≤.04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95% CI 0.02–0.11; P =.004). Global satisfaction after treatment was 89.6% (121/135). Clinical Translation: This modified CCH treatment protocol could improve both patients’ and partner's sexual function. Strength and limitations: This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account. Conclusions: The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients’ and partners’ sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716–721. © 2018 International Society for Sexual Medicine

AB - Background: Collagenase Clostridium histolyticum (CCH; Xiapex) injections represent the only licensed medical treatment for Peyronie's disease (PD). Aim: To evaluate the efficacy and safety of CCH injections in men with stable PD, using a modified treatment protocol and to assess partners’ bother improvement in a large cohort of White-European sexually active heterosexual men treated in a single tertiary-referral center. Methods: All the 135 patients enrolled underwent a thorough assessment, which included history taking, physical examination, and pharmacologically induced artificial erection test (intra-cavernous injection) to assess the degree of penile curvature (PC) at baseline and after the completion of the treatment. Patients with calcified plaque and/or ventral curvature were excluded. All patients underwent a modified treatment protocol, which consisted of 3 intra-lesional injections of 0.9 mg of CCH performed at 4-week intervals at the point of maximum curvature. After each injection, patients were instructed to follow a strict routine involving daily penile stretching in the intervals between injections. Outcomes: International Index of Erectile Function (IIEF)–15, Global Assessment of PD, PD questionnaires (PDQ), and Female Sexual Function Index (FSFI) questionnaire were performed at baseline and at the end of treatment. Results: Overall, 135 patients completed the study protocol. Before treatment, 18 (13.33%) partners showed a degree of sexual dysfunction. Baseline median IIEF–15, FSFI, and PDQ scores were, respectively, 59.0, 35.0, and 23.0. Overall, both IIEF–total and all domains significantly improved after treatment (all P <.01). A PC mean change of 19.07 (P =.00) was measured. At the univariate linear regression analysis, IIEF–15, IIEF–erectile function, IIEF–sexual desire, and IIEF–intercourse satisfaction were positively associated with FSFI (all P ≤.03); conversely, PDQ–penile pain, PDQ–symptom bother, and post-treament penile curvature (P ≤.04) were associated with a decreased FSFI score. Furthermore, median change of PC was significantly associated with median change of FSFI (r = 0.25; 95% CI 0.02–0.11; P =.004). Global satisfaction after treatment was 89.6% (121/135). Clinical Translation: This modified CCH treatment protocol could improve both patients’ and partner's sexual function. Strength and limitations: This was an open-label, single-arm clinical study, without placebo. where only heterosexual couples in stable relationships were included. Furthermore, no real assessment of female sexual distress was carried out and long-term sexual function in both patients and female partners were not taken into account. Conclusions: The modified treatment schedule with CCH injections for stable PD has a positive impact on both patients’ and partners’ sexual function in heterosexual couples with a stable sexual relationship. Cocci A, Russo GI, Salonia A, et al. Predictive Factors of Patients’ and Their Partners’ Sexual Function Improvement After Collagenase Clostridium Histolyticum Injection for Peyronie's Disease: Results From a Multi-Center Single-Arm Study. J Sex Med 2018;15:716–721. © 2018 International Society for Sexual Medicine

U2 - 10.1016/j.jsxm.2018.03.084

DO - 10.1016/j.jsxm.2018.03.084

M3 - Article

VL - 15

SP - 716

EP - 721

JO - Journal of Sexual Medicine

JF - Journal of Sexual Medicine

SN - 1743-6095

IS - 5

ER -