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Efficacy and safety of collagenase Clostridium histolyticum in Peyronie’s disease following a modified treatment protocol
Eficacia y seguridad de la colagenasa de Clostridium histolyticum en la enfermedad de Peyronie según un protocolo de tratamiento modificado
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García Cruz, C. Mercader Barrull, D. Camacho Rovira, A. Alcaraz Asensio" "autores" => array:4 [ 0 => array:3 [ "nombre" => "E." "apellidos" => "García Cruz" "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 1 => array:4 [ "nombre" => "C." "apellidos" => "Mercader Barrull" "email" => array:1 [ 0 => "mercaderclaudia@gmail.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 2 => array:3 [ "nombre" => "D." "apellidos" => "Camacho Rovira" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "A." "apellidos" => "Alcaraz Asensio" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Departamento de Urología, Hospital Clínic, Barcelona, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Clínica Vigora, Barcelona, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Departamento de Urología, Hospital Plató, Barcelona, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Eficacia y seguridad de la colagenasa de <span class="elsevierStyleItalic">Clostridium histolyticum</span> en la enfermedad de Peyronie según un protocolo de tratamiento modificado" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1627 "Ancho" => 2500 "Tamanyo" => 76884 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Distribution of CCH injection.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Peyronie’s disease (PD) is a condition that results from a local inflammatory disorder within the tunica albuginea. It leads to an excessive deposit of collagen fibers and consequently to the formation of a fibrous plaque that reduces elasticity, thus causing curvature and deformity during erection. The patients may undergo penile pain, certain penile shortening, erectile dysfunction (ED), difficulties during sexual intercourse or might notice a palpable plaque.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> The condition affects from 0.7% to 11% of men and its etiology is still unknown. However, it is thought that repetitive trauma or microvascular insult to the albuginea might be the trigger.<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2,3</span></a> Historically, conservative therapies have failed to demonstrate clinical efficacy. Therefore, surgical therapies have been traditionally considered as the gold standard for correcting penile curvature despite being an invasive treatment.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Collagenase clostridium histolyticum (CCH) was first licensed as a non-surgical treatment for Peyronie’s disease by the USA Food and Drug Administration in 2013 and by the European Medicines Agency in 2015. CCH consists of a mixture of purified collagenases (Classes AUX-I and AUX-II) naturally produced by the <span class="elsevierStyleItalic">Clostridium histolyticum</span> bacterium. When injected intralesional, the compound leads to an enzymatic disruption of the PD plaque by synergistically hydrolyzing the triple helical conformation of collagen types I and III.<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies I and II (IMPRESS I and IMPRESS II) are two identically designed, large, randomized, controlled phase III clinical trials that investigate intralesional CCH injection in men with PD. Both have demonstrated significant reduction in penile curvature (34% CCH vs 18% placebo) and in symptom bother scores. CCH therapy candidates are patients with a stable PD and penile curvatures between 30–90° (excluding ventral curvatures, isolated hourglass deformity and calcified plaques). The standard protocol consists of a maximum of four treatment cycles, each of which consists of two intralesional injections of 0.58 mg of CCH administered 24–72 h apart and followed by manual penile modelling. A period of six weeks must be allowed between cycles.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6,7</span></a> Despite the fact that the current IMPRESS protocol offers an effective and a safe profile, it is clinically and economically demanding. Different groups have already started to modify the protocol trying to optimize the treatment while maintaining its efficacy and safety profile.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11–13</span></a> The aim of this study is to evaluate the efficacy and safety of CCH in patients with Peyronie’s disease (PD) undergoing a modified treatment protocol.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Subjects and methods</span><p id="par0015" class="elsevierStylePara elsevierViewall">This is a prospective evaluation of patients with PD who were treated with CCH (Xiapex [Pfizer Inc., New York, NY, USA], Xiaflex [Endo Pharmaceuticals Inc., Dublin, Ireland]) at a single center using a new modified protocol from June 2016 to December 2018. As in the IMPRESS trials, treatment was indicated for men with PD in stable phase and curvatures between 30 and 90°, excluding those patients with ventral curves, complex deformities or calcified plaques. The primary outcome in order to evaluate efficacy was the final change in curvature after completing CCH therapy. The primary endpoint used to evaluate safety was the frequency of a severe treatment-related adverse event (TRAE), defined as a complication directly caused by the CCH therapy. These include corporal rupture, penile hematoma, hematuria or local infection after CCH injections. This study was approved by our institutional review board and all patients enrolled were well informed and gave consent.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The medical records were reviewed, and data were collected before and after treatment. Variables of interest included past clinical history, age, Charlson Score, testosterone (TST) and sex hormone binding globulin (SHBG) blood levels, penile curvature before and after the treatment (monitored via the Kelami test), erectile function (EHS),<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> outpatient appointments and number of injections. Patients were instructed as to the signs and symptoms that should be evaluated at the emergency area in order to discard major complications.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Under a dorsal penile nerve block and in flaccid state, we administered a full single dose (0.9 mg) distributed in two lines of four punctures along the PD plaque (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). All treatments were applied by the same doctor (Dr. EGC). Penile compression was not applied, and anti-inflammatory medication was not routinely prescribed. Patients were instructed to keep the penis in an upwards position and to avoid sexual intercourse for 2 weeks. In-office plaque modelling was not performed. Instead, patients were instructed in daily stretching and straightening penile exercises that must be started the day after the procedure and that should go on until the following visit. Patients were advised to use a penile-traction device on a non-erect penis 6 hours a day. Patients were re-evaluated 4 weeks after the procedure, and if needed, further injections were administered up to a maximum of 8 or until a curve diminishment of 30°.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">The IBM Statistical Package for the Social Sciences (SPSS version 23.0; IBM Corp., Armonk, NY, USA) was used for the statistical analyses. The normal distribution of variables was tested using the Shapiro–Wilk normality test, so that paired t-test was used to compare curvatures before and after treatment.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Results</span><p id="par0035" class="elsevierStylePara elsevierViewall">A total of 33 patients were treated for PD with CCH at our center from June 2016 to December 2018, and 31 were included for this study. Two patients were lost to follow-up. Mean age was 58.29 (±7.43) years, none of them had alterations in SHBG (43.06 ± 15.73) or TST (43.06 ± 15.73) levels. The most frequent comorbidities were type 2 diabetes mellitus (12.9%) and neoplasms (12.9%). Further patient characteristics are shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">The mean initial curvature was 49.84 (±15.83, range 30–90)°. Curvature characteristics and total number of injections are shown in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>. The mean absolute curvature decrease was 20.65 (±15.42, range 0–45)°, with a mean post-treatment curvature of 30.67 (±17.25, range 0–90)° and a mean overall relative improvement from baseline of 44%. The treatment failed in one patient who completed the total of 8 injections, the patient had an initial curvature of 90°. Five patients abandoned the treatment after 3 injections without any improvement and we also considered these as a failure. These patients had a mean initial curvature of 39.00 (±8.22) and a mean improvement of 3.00 (±6.7) when they decided to stop treatment. From the total of six (19.4%) patients that failed CCH treatment, five of them underwent Nesbit corporoplasty with satisfactory results.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0045" class="elsevierStylePara elsevierViewall">Treatment was well-tolerated by all patients and the only side effects reported were minimal and transient penile swelling or minimal bruising in the puncture site. No patient presented post-procedure complications, although two patients (6.5%) complained about subjective penile shortening. After the treatment, EHS values showed no change.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Discussion</span><p id="par0050" class="elsevierStylePara elsevierViewall">Several options of conservative treatment for PD have been suggested, including oral pharmacotherapy, topical agents, intralesional injection therapy, penile traction or shockwave treatment.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Due to several methodological problems including uncontrolled studies, limited number of patients treated, different outcome measures, poor reproducibility and short-term follow-up, there is low statistical power and contradictory results making it difficult to provide strong clinical recommendations.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Nevertheless, CCH is the only drug approved for the treatment of PD by the FDA and the EMA and has been shown to be safe and effective not only in two large phase III randomized, double-blind, placebo-controlled studies (IMPRESS I and II) but also in post-approval trials.<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10–19</span></a> Our aim is to analyze the results in terms of efficacy and safety of a modified CCH treatment protocol.</p><p id="par0055" class="elsevierStylePara elsevierViewall">The IMRESS protocol involves up to four treatment cycles separated by six weeks, each treatment cycle consisting of two CCH injections (0.58 mg) punctured at the point of the plaque causing the maximal penile curvature, in the flaccid state. Both injections in each cycle are separated by 1–3 days. 1–3 days after the second injection, physician plaque modelling is performed by stretching and bending the penis in the opposite direction to the point of maximum curvature. In between treatment cycles, patients have to perform penile stretching and straightening exercises at home. Thus, the patient must attend 14 outpatient appointments over 24 weeks. IMPRESS studies showed that patients treated with CCH had a statistically significant greater decrease in penile curvature compared with those receiving placebo (17.0°, mean improvement of 34%, vs 9.3°, mean improvement of 18.2%, respectively). Treatment-related adverse events were mostly mild and only 0.72% developed serious adverse events requiring intervention.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6,7</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">The current IMPRESS protocol offers a great efficacy and safety profile, but it is both clinically and economically demanding. Thus, different groups have tried other treatment protocols that provide a more cost-effective profile. They achieve this by reducing the dosage and number of medical visits that might not provide added clinical benefit. Ziegelmann et al., carried out a discrete modification in which 69 patients were instructed to perform the modelling exercises themselves instead of the physician. Modelling began on the first day of injection, yielding effectivity and safety results comparable to those in the classical protocol.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> In our modified protocol, we also incorporated the home-modelling exercises instead of the classic physician-modelling. Fernández-Pascual et al. combined the percutaneous needle tunneling with the CCH treatment by creating multiples wholes percutaneously in the plaque before each injection.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> In our protocol we also incorporated this idea of the needle tunneling by distributing the treatment in two lines of four punctures along the PD plaque. <span class="elsevierStyleItalic">Abdel-Raheem et al</span>., conducted a prospective study with 53 patients, administering a single 0.9 mg dose injection along three lines around the point of maximum curvature for 4 cycles, 6 weeks apart. Patients were instructed to use the vacuum system instead of performing modelling exercises. There was a mean improvement in penile curvature of 17.36° and there were no major complications. This protocol included 4 outpatient appointments during the treatment with CCH.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a><span class="elsevierStyleItalic">Capece et</span> out a prospective study with 135 patients receiving three 0.9 mg intralesional injections of CCH at a 4-weekly interval. The whole vial was injected at the point of maximal curvature and they applied a 24 h slight compression. Patients were instructed to perform modelling exercises the day after the procedure and started using the vacuum system 48-72 h after the injection. There was a mean curvature improvement of 19.1° and no significant post-procedure complications were reported. Only three outpatient appointments where required in this protocol and less doses of CCH were administered compared to the IMPRESS trials.<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> Despite there is limited evidence about the use of penile traction devices combined with CCH treatment for PD, we also decided to incorporate this devices in our protocol. Recently, both <span class="elsevierStyleItalic">Alom</span> et al. and <span class="elsevierStyleItalic">Ziegelmann</span> et al. presented their experience combining the RestoreX® device plus CCH treatment in men with PD and both demonstrated its safety and a significant curvature and length improvement.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15,16</span></a> However, there is no data about patient adherence to penile traction therapy or modelling exercises.</p><p id="par0065" class="elsevierStylePara elsevierViewall">The results of our modified protocol show a mean absolute curvature reduction of 20.65° and a relative reduction of 44% from baseline, which is comparable to those described in the IMPRESS trials. We think that using 8 different punctures points along the PD plaque may add to the lysing effect of the CCH itself, a mechanical rupture and weakening of the plaque effect, thus, improving its efficacy. We also re-evaluated the need for new cycles of treatment consequently reducing the administration of injections that might not be providing any clinical benefit (mean of 2 vs. 8 in the IMPRESS trials). Moreover, we thoroughly trained the patient to perform the stretching and straightening penile exercises by themselves, which also reduces the need for outpatient appointments (mean of 2 vs. 14 in the IMPRESS trials). In our series, there were no complications reported other than local penile bruising, swelling and bother around the injection area. This shows a security profile comparable to the IMPRESS trials.</p><p id="par0070" class="elsevierStylePara elsevierViewall">The limitations of our series must be considered. First, we present a single-center, single-urologist experience, including a small sample size without a control group which might affect its reproducibility. The small sample was limited by a restricted budget in the employment of CCH for PD at our hospital during the trial period. The variable adherence to the modelling exercises and employment of the penile-traction device may potentially lead to differences in clinical outcomes. Finally, the follow-up has been limited in some cases, potentially inducing a bias in the determination of the final curvature outcome.</p><p id="par0075" class="elsevierStylePara elsevierViewall">CCH is an effective and safe intralesional treatment for PD that reduces penile curvature and may avoid the need of invasive surgical treatment. The future goals are to identify those patients who will benefit the most from the treatment, to optimize the treatment protocol as much as possible and to define its possible role during the acute phase of the disease.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Conclusion</span><p id="par0080" class="elsevierStylePara elsevierViewall">Our study shows that another kind of protocol can be applied to patients suffering from PD, maintaining a safety profile and a rate of efficacy comparable to the IMPRESS trials. Also, our approach benefits both patients and the medical care system by potentially reducing costs and time-consuming outpatient visits without compromising the benefit of CCH. However, further studies with larger samples and longer follow-up are still required to bring more light to this matter.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Conflict of interest</span><p id="par0085" class="elsevierStylePara elsevierViewall">None of the authors have any conflict of interests to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:11 [ 0 => array:3 [ "identificador" => "xres1491711" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Materials and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1354319" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1491712" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Materiales y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1354318" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Subjects and methods" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0025" "titulo" => "Conclusion" ] 9 => array:2 [ "identificador" => "sec0030" "titulo" => "Conflict of interest" ] 10 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2020-01-28" "fechaAceptado" => "2020-06-30" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1354319" "palabras" => array:5 [ 0 => "Peyronie’s disease" 1 => "Collagenase <span class="elsevierStyleItalic">Clostridium histolyticum</span>" 2 => "Xiapex" 3 => "Xiaflex" 4 => "Intralesional injections" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1354318" "palabras" => array:5 [ 0 => "Enfermedad de Peyronie" 1 => "Colagenasa de <span class="elsevierStyleItalic">Clostridium histolyticum</span>" 2 => "Xiapex" 3 => "Xiaflex" 4 => "Inyección intralesional" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Collagenase <span class="elsevierStyleItalic">Clostridium histolyticum</span> (CCH) is the only approved treatment for conservative management of Peyronie’s disease (PD) that has demonstrated efficacy and safety in clinical trials. However, as the standard treatment protocol is time and resource consuming, we are introducing a new CCH treatment protocol with a more cost-effective profile. Our goal is to evaluate its efficacy and safety.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">We included patients with PD in stable phase, with curvatures of 30–90°. Ventral curvatures and complex deformities were excluded. The treatment protocol consists of a full dose of CCH injected along the PD plaque, forming two lines of four injections. Patients were educated in daily penile modeling activities. The need for a new treatment cycle, up to a maximum of 8 cycles or until the 30° curve was decreased, was reevaluated every 4 weeks. Changes in curvature and number of cycles were recorded to evaluate the efficacy. Regarding safety evaluation, treatment-related adverse events (TRAEs) were recorded, including rupture of the corpora cavernosa, penile hematoma, hematuria, and local infection.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Thirty-one patients were treated under the modified protocol. The mean initial curvature was of 49.84 (±15.83)°. Curvature improvement was recorded in 25 patients (80.6%), with a mean absolute reduction of 20.65 (±15.42)° and relative reduction of 44%. The mean curvature after treatment was 30.67 (±17.25)°. Most patients required one (19.4%) or two (54.8%) injections. No patient presented TRAEs.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">The results suggest that the modified CCH treatment protocol is effective and safe, but more studies should be carried out to optimize the current standard protocol.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Materials and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducción</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">La colagenasa de <span class="elsevierStyleItalic">Clostridium histolyticum</span> (CCH) es el único medicamento con licencia para el tratamiento conservador en la enfermedad de Peyronie (EP) que ha demostrado eficacia y seguridad en ensayos clínicos. Sin embargo, el protocolo de tratamiento estándar consume tiempo y recursos, por lo que presentamos un nuevo protocolo de tratamiento con CCH con un perfil más rentable. Nuestro objetivo es evaluar su eficacia y su seguridad.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Materiales y métodos</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron pacientes con EP en fase estable, con curvaturas de 30–90°. Se excluyeron curvas ventrales y deformidades complejas. El protocolo de tratamiento consiste en una dosis completa de CCH inyectada a lo largo de la placa de EP formando 2 líneas de 4 inyecciones. Se educó a los pacientes en los ejercicios diarios de modelado del pene. La necesidad de un nuevo ciclo de tratamiento fue reevaluada cada 4 semanas hasta un maximo de 8 ciclos o hasta la disminución de la curva de 30°. Para evaluar la eficacia se registraron los cambios en la curvatura y el número de ciclos. Para evaluar la seguridad se registraron los eventos adversos graves relacionados con el tratamiento, incluyendo la rotura de cuerpos cavernosos, hematoma peneano, hematuria e infección local.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Un total de 31 pacientes fueron tratados bajo el protocolo modificado. La curvature inicial media fue de 49,84 (±15,83) grados. Se registró mejora en la curvatura en 25 pacientes (80,6%), con una disminución media absoluta de 20,65 (±15,42) grados y relativa del 44%. La curvatura media posterior al tratamiento fue de 30,67 (±17,25) grados. La mayoría de los pacientes requirieron una (19,4%) o dos (54,8%) inyecciones. Ningún paciente presentó eventos adversos graves relacionados con el tratamiento.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Los resultados sugieren que el protocolo de tratamiento modificado con CCH es eficaz y seguro, pero se deben realizar más estudios que ayuden a optimizar el protocolo estándar actual.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Materiales y métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: García Cruz E, Mercader Barrull C, Camacho Rovira D, Alcaraz Asensio A. Eficacia y seguridad de la colagenasa de <span class="elsevierStyleItalic">Clostridium histolyticum</span> en la enfermedad de Peyronie según un protocolo de tratamiento modificado. Actas Urol Esp. 2021;45:215–219.</p>" ] ] "multimedia" => array:3 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1627 "Ancho" => 2500 "Tamanyo" => 76884 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Distribution of CCH injection.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:2 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Charlson Score \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">% \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9.7 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">32.3 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">35.5 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12.9 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6.5 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2562160.png" ] ] 1 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">EHS \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">% \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Missed \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6.5 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">35.5 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">58.1 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2562161.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Patients characteristics.</p>" ] ] 2 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:2 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Curvature deviation \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">% \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Dorsal \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">58.1 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Right \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Left \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">16.1 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Dorsal-right \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9.7 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Dorsal-left \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12.9 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2562162.png" ] ] 1 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Number of injections \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">% \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">19.4 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">54.8 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">12.9 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">4 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">9.7 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">5 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">6 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">3.2 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2562159.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Curvature characteristics and total number of injections.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:19 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "An analysis of the natural history of Peyronie’s disease" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "J.P. 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