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"apellidos" => "Hernández Fernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Sección de Urología Funcional, Reconstructiva y Andrología-Servicio de Urología, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Gregorio Marañón, Universidad Complutense, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Facultad de Medicina, Universidad Complutense, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Facultad de Medicina, Universidad Europea, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Estudio de evaluación de satisfacción en pacientes con/sin enfermedad de Peyronie e implante de prótesis de pene, y sus parejas" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Erectile dysfunction (ED) is defined as the inability to achieve or maintain a penile erection sufficient for satisfactory sexual activity. This pathology mainly affects men over the age of 40, with a clear increase in incidence as age increases.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,2,3</span></a> The inflatable penile prosthesis (IPP) allows for high patient satisfaction, reaching rates >80%.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,5</span></a> The patient’s sexual satisfaction is strongly linked to the couple's satisfaction, making it one of the main factors to be assessed.</p><p id="par0010" class="elsevierStylePara elsevierViewall">PD produces penile deformation due to fibrosis of the tunica albuginea and was first described by FG de la Peyronie in the 18th century.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> The therapeutic approach can be very heterogeneous.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> It is adapted to the natural course of the disease, which can be very variable until its stabilization (about 12 months). From conservative measures to surgical treatment, when the disease makes penetration difficult (corporoplasty and/or plication). If there is concomitant ED, the treatment of choice is PP implantation.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Sexual satisfaction both in patients with PP and in their respective partners after the implant is an aspect of utmost importance. There are also significant differences between those patients with penile prostheses with previous PD and patients who did not suffer from this condition. Penile prosthesis implantation is the indicated treatment option in patients with PD and concomitant ED,<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> although overall, patients with Peyronie's show, according to some authors, lower comparative satisfaction results than patients without PD.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a></p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Objectives</span><p id="par0020" class="elsevierStylePara elsevierViewall">To evaluate and compare the level of satisfaction in patients with IPP and their partners, both in those with PD and in patients who do not suffer from this pathology.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Material and methods</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Study design</span><p id="par0025" class="elsevierStylePara elsevierViewall">This is a retrospective study carried out using a questionnaire, designed by our group, which consists of five questions about the patient's sexual satisfaction. Such a questionnaire is administered to all living patients and their partners who have received a penile prosthesis implant in the period from 1992 to 2022 at the Gregorio Marañón General University Hospital, and who agree to take part.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Study population and study period</span><p id="par0030" class="elsevierStylePara elsevierViewall">The study population is made up of patients who underwent the implantation of</p><p id="par0035" class="elsevierStylePara elsevierViewall">a three-component penile prosthesis for the treatment of erectile dysfunction at the Gregorio Marañón General University Hospital in Madrid during the period 1992–2022.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Inclusion criteria</span><p id="par0040" class="elsevierStylePara elsevierViewall">The criteria used for the inclusion of patients in the sample analyzed in</p><p id="par0045" class="elsevierStylePara elsevierViewall">this study is:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0050" class="elsevierStylePara elsevierViewall">Male patients ≥ 18 years</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0055" class="elsevierStylePara elsevierViewall">Diagnosis of ED refractory to other treatments</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0060" class="elsevierStylePara elsevierViewall">Treatment by surgical implantation of 3-component hydraulic prostheses</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0065" class="elsevierStylePara elsevierViewall">Operated on at the Gregorio Marañón General University Hospital</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0070" class="elsevierStylePara elsevierViewall">Surgery carried out during the period from November 1992 until November 2021</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0075" class="elsevierStylePara elsevierViewall">Verified informed consent signature for the PP implementation</p></li></ul></p><p id="par0080" class="elsevierStylePara elsevierViewall">All implant candidates had been previously evaluated at this center’s Andrology Clinic. Each patient received an assessment of their therapeutic options in accordance with the clinical and diagnostic criteria established in the clinical guidelines and the criteria of experts.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Exclusion criteria</span><p id="par0085" class="elsevierStylePara elsevierViewall">All patients who do not comply with the previously established inclusion criteria, or that meet one or more of the following criteria, are excluded from the present study:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">•</span><p id="par0090" class="elsevierStylePara elsevierViewall">Deceased patients</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">•</span><p id="par0095" class="elsevierStylePara elsevierViewall">Absence of a partner to do the questionnaire with</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">•</span><p id="par0100" class="elsevierStylePara elsevierViewall">Malleable or hydraulic 2-component prostheses</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">•</span><p id="par0105" class="elsevierStylePara elsevierViewall">Not wishing to participate in the study/answer the questions – the patient himself or his partner.</p></li></ul></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Sample size</span><p id="par0110" class="elsevierStylePara elsevierViewall">Sample selection was carried out by recruiting consecutive cases (non-probability sampling) specific to the study period, in which all individuals who met the previously described inclusion criteria have been identified.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Study variables (Appendix 1)</span><p id="par0115" class="elsevierStylePara elsevierViewall">The variables refer specifically to the questions asked in the questionnaire. They were classified into 5 questions for patients and 1 question for partners (question 1), categorizing the percentage of answers 0–1–2–3 except in question 3 (2 levels: yes–no).</p><p id="par0120" class="elsevierStylePara elsevierViewall">Other demographic and background variables (medical, pharmacological, or surgical) were not included in this study. They were not considered determinants for the objective of the study, which was specifically to know the degree of satisfaction of the patient and partner with their sexual relationships.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Material used</span><p id="par0395" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">•</span><p id="par0125" class="elsevierStylePara elsevierViewall">Database of patients implanted in the center during the period from 1992 and 2022.</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">•</span><p id="par0130" class="elsevierStylePara elsevierViewall">The questionnaire is based on five questions asked to the patients in question:<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">1.</span><p id="par0135" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">What is your level of satisfaction during sexual intercourse?</span></p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">2.</span><p id="par0140" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Do you have any difficulty using the prosthesis?</span></p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">3.</span><p id="par0145" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Would you undergo the procedure again?</span></p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">4.</span><p id="par0150" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Has any aspect of your satisfaction during intercourse been altered while the prosthesis was activated?</span></p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">5.</span><p id="par0155" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Is penis length or the consistency of the glans sufficient during intercourse?</span></p></li></ul></p></li></ul></p><p id="par0160" class="elsevierStylePara elsevierViewall">The partner only receives question 1. Questions 2–5 are not applicable as they are more directed to the subjective personal area of appreciation of patient-prosthesis interaction. For each of these questions, the patient must give a numerical rating between 0 and 3 (except for question 3 where the answer possibilities are two: yes–no), establishing the following relationship:<ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">•</span><p id="par0165" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">0: Not satisfied</span></p></li><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">•</span><p id="par0170" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">1: Slightly satisfied</span></p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">•</span><p id="par0175" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">2: Moderately satisfied</span></p></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">•</span><p id="par0180" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">3: Very satisfied</span></p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">•</span><p id="par0185" class="elsevierStylePara elsevierViewall">Main unit of measurement of the results obtained: level of satisfaction of the patient and his partner after the implantation of the penile prosthesis.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">•</span><p id="par0190" class="elsevierStylePara elsevierViewall">For the purposes of evaluating results, in order to facilitate the transmission of information, we differentiate two global categories: slightly or not satisfied (0–1) vs. moderately or very satisfied (2–3) (questions 1–2; 4−5); YES-NO (question 3).</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">•</span><p id="par0195" class="elsevierStylePara elsevierViewall">Statistical study: The discrete qualitative and quantitative variables were described by the absolute and relative frequencies (percentages) of each of their categories. Confidence intervals were calculated for 95% (95% CI) of the sample in all the parameters evaluated. A qualitative test (chi-squared — χ<span class="elsevierStyleSup">2</span>) was used to determine the statistical significance of the frequencies observed between groups in relation to the response categories. The comparison between means of quantitative variables was carried out using the Student’s <span class="elsevierStyleItalic">t</span>-test. The level of statistical significance for all the tests used is set at p<span class="elsevierStyleHsp" style=""></span>≤<span class="elsevierStyleHsp" style=""></span>0.05</p></li></ul></p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Study population</span><p id="par0200" class="elsevierStylePara elsevierViewall">When carrying out the analysis, the population under study is divided into three groups, to which the same questionnaire is administered by telephone. This study population is made up of all living patients (and their partners, if applicable) who have undergone one/several penile prosthesis implantation procedures between the years 1992 and 2022 at the Gregorio Marañón General University Hospital. The surgeries were performed mainly by two surgeons. The patients’ risk factors were not considered for the analysis to simplify the pure analysis of the satisfaction obtained.</p><p id="par0205" class="elsevierStylePara elsevierViewall">These being the criteria, the study population sample is made up of 570 patients with functional prostheses at the time of the survey.</p><p id="par0210" class="elsevierStylePara elsevierViewall">Thus, patients are divided into the following three groups:<ul class="elsevierStyleList" id="lis0030"><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">•</span><p id="par0215" class="elsevierStylePara elsevierViewall">Group 1: Patients who do not suffer from PD.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">•</span><p id="par0220" class="elsevierStylePara elsevierViewall">Group 2: Patients who suffer from non-complex PD (curvature that is corrected with the implant<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>manual modeling without the need for grafts)</p></li><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">•</span><p id="par0225" class="elsevierStylePara elsevierViewall">Group 3: Patients suffering from complex PD (hourglass penile deformity, other severe deformities, severe penile shortening, bent penis, calcification or complex plaques that imply the need for further surgical manipulation and/or use of grafts).</p></li></ul></p><p id="par0230" class="elsevierStylePara elsevierViewall">Of these 570 patients and respective partners who met the criteria required in the study (having a functioning 3-component prosthesis, understanding of the explanation given, and acceptance of participating anonymously, both they and the partner), 479 completed the survey, (84% of the initial sample). Based on the division of patients carried out previously, the following results are obtained:<ul class="elsevierStyleList" id="lis0035"><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">•</span><p id="par0235" class="elsevierStylePara elsevierViewall">Group 1: 393 patients and their partners complete the survey.</p></li><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">•</span><p id="par0240" class="elsevierStylePara elsevierViewall">Group 2: 70 patients and their partners complete the survey.</p></li><li class="elsevierStyleListItem" id="lsti0150"><span class="elsevierStyleLabel">•</span><p id="par0245" class="elsevierStylePara elsevierViewall">Group 3: 16 patients and their partners complete the survey.</p></li></ul></p><p id="par0250" class="elsevierStylePara elsevierViewall">The mean age of the patients at the time of the study was:<ul class="elsevierStyleList" id="lis0040"><li class="elsevierStyleListItem" id="lsti0155"><span class="elsevierStyleLabel">•</span><p id="par0255" class="elsevierStylePara elsevierViewall">Group 1: 61.4 years (44–78)</p></li><li class="elsevierStyleListItem" id="lsti0160"><span class="elsevierStyleLabel">•</span><p id="par0260" class="elsevierStylePara elsevierViewall">Group 2: 57.7 years (42–70)</p></li><li class="elsevierStyleListItem" id="lsti0165"><span class="elsevierStyleLabel">•</span><p id="par0265" class="elsevierStylePara elsevierViewall">Group 3: 56.3 years (41–71)</p></li></ul></p><p id="par0270" class="elsevierStylePara elsevierViewall">Without significant differences between them.</p></span></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Results</span><p id="par0275" class="elsevierStylePara elsevierViewall">Once the patients for the study were selected and the survey was carried out on all those who agreed to participate, the following results were obtained:</p><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Results of the patient survey (Appendix 2, 3)</span><p id="par0400" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0045"><li class="elsevierStyleListItem" id="lsti0170"><span class="elsevierStyleLabel">•</span><p id="par0280" class="elsevierStylePara elsevierViewall">86% of patients in Group 1 are satisfied overall during sexual activity (score 2–3). On the contrary, 14% report dissatisfaction during sexual intercourse after implantation of the device (score 0–1) (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05).</p></li><li class="elsevierStyleListItem" id="lsti0175"><span class="elsevierStyleLabel">•</span><p id="par0285" class="elsevierStylePara elsevierViewall">81% of patients in Group 2 are satisfied overall after implantation (score 2–3); 19% of this group is not satisfied (score 0–1) (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05).</p></li><li class="elsevierStyleListItem" id="lsti0180"><span class="elsevierStyleLabel">•</span><p id="par0290" class="elsevierStylePara elsevierViewall">61% of the patients in Group 3 are satisfied overall. The remaining 39% are not satisfied during intercourse (score 0–1) (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01 in both cases). In this group, it is worth highlighting the striking difference between those patients who report moderate satisfaction versus those who report high satisfaction, with those belonging to the first group predominating. The percentages are 78% versus 22%, respectively (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01).</p></li></ul></p><p id="par0295" class="elsevierStylePara elsevierViewall">Additionally, after evaluating the results of the survey it was possible to verify:<ul class="elsevierStyleList" id="lis0050"><li class="elsevierStyleListItem" id="lsti0185"><span class="elsevierStyleLabel">✓</span><p id="par0300" class="elsevierStylePara elsevierViewall">84% of patients in Group 1 and 79% of patients in Group 2 (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05) report that they would undergo the procedure again if they lost use of the device. However, only 50% of the patients in Group 3 (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.05 in both cases) offered an affirmative answer to this question.</p></li><li class="elsevierStyleListItem" id="lsti0190"><span class="elsevierStyleLabel">✓</span><p id="par0305" class="elsevierStylePara elsevierViewall">39% of the patients in Group 3 have some issue during activation of the device that alters satisfaction in the relationship (14% Group 1–19% Group 2, p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.05); 45% of patients in Group 3 report significant penile shortening and/or cold glans (7.7% Group 1–10.8% Group 2, p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.05). The most frequent cause of dissatisfaction in Group 1 was the length of the penis (12%) and alterations in the glans (2%). In Group 2, penis length was a problem in 14%, with 5% experiencing discomfort in the glans.</p></li><li class="elsevierStyleListItem" id="lsti0195"><span class="elsevierStyleLabel">✓</span><p id="par0310" class="elsevierStylePara elsevierViewall">A global 18.4% of all patients report difficulties when activating/deactivating the device.</p></li></ul></p><p id="par0315" class="elsevierStylePara elsevierViewall">Differences between periods were not considered in order to simplify the overall evaluation of results, due to the long period considered.</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Results of the survey of patients' partners (Appendix 4)</span><p id="par0405" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0055"><li class="elsevierStyleListItem" id="lsti0200"><span class="elsevierStyleLabel">•</span><p id="par0320" class="elsevierStylePara elsevierViewall">84% of patients’ partners in Group 1 report having satisfactory sexual relations (score 2–3). 16% report being dissatisfied (score 0–1) (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05).</p></li><li class="elsevierStyleListItem" id="lsti0205"><span class="elsevierStyleLabel">•</span><p id="par0325" class="elsevierStylePara elsevierViewall">80% of patients’ partners in Group 2 claimed to be satisfied during intercourse (score 2–3), while 20% were dissatisfied (score 0–1) (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05).</p></li><li class="elsevierStyleListItem" id="lsti0210"><span class="elsevierStyleLabel">•</span><p id="par0330" class="elsevierStylePara elsevierViewall">54% of patients’ partners in Group 3 report having satisfactory sexual relations (score 2–3); the remaining 46% are not satisfied with their sexual encounters (score 0–1) (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01). (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01).</p></li></ul></p><p id="par0335" class="elsevierStylePara elsevierViewall">Similarly, no differences between periods were considered in order to simplify the overall evaluation of results, due to the lengthy period considered.</p></span></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Discussion</span><p id="par0340" class="elsevierStylePara elsevierViewall">Between 20–45% of patients with PD suffer from concomitant ED, which is generally due to the disease's own variations. It is in these patients that PP implantation is recommended as the first line of treatment. In patients with persistent curvature not corrected by the implant, the simple use of the prosthesis is not enough (curvature >30°), requiring additional procedures such as manual modeling or corporoplasty techniques with or without the use of grafts.<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9–13</span></a></p><p id="par0345" class="elsevierStylePara elsevierViewall">Our work evaluated a population of 630 patients with implants and their partners through a telephone survey. The use of non-validated/non-specific quality of life questionnaires in the general population is a widespread fact in the literature. This use introduces a variability factor which, although it does not invalidate the conclusions, should be avoided by carrying out prospective studies and use of validated and specific questionnaires for patients with penile prostheses and their partners.<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">4,14</span></a></p><p id="par0350" class="elsevierStylePara elsevierViewall">Patients with PD, and especially those with complex PD, represent a special subgroup because of their implications and surgical difficulty due to the frequent need for plaque removal and use of grafts. Our work involves special preoperative consideration of the implications of these cases, with individualized discussion of potential expectations with patients and their partners, which helps in the decision-making process and even avoids subsequent medico-legal problems. We did not study the differences perceived by patients and their partners separately between periods to simplify the overall evaluation of results, due to the wide range of years considered.</p><p id="par0355" class="elsevierStylePara elsevierViewall">PP implantation has been associated with a high degree of satisfaction, as verified by our group in previous publications.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Akakpo et al.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> studied the postoperative satisfaction of PP patients and observed that it is strongly influenced by the characteristics of their pathology as well as preoperative expectations. Patient satisfaction, as well as the consequent satisfaction of their partners, is evidently influenced by the specific characteristics of the population subgroup. This fact is evident in our work. The subgroup with PD of higher complexity showed significantly worse satisfaction results. Our patients with PD without high complexity showed a high degree of satisfaction without differences with patients without PD, in line with other publications.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> Regarding technical aspects, the anatomical location of the reservoir does not seem to be a significant determinant of patient satisfaction in the literature.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a></p><p id="par0360" class="elsevierStylePara elsevierViewall">Ziegelmann et al.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> conducted a survey on patient satisfaction after penile prosthesis implantation, making a comparison between patients who suffered from PD and those who did not. She concludes that among patients who had received simple surgery there was no significant difference regarding satisfaction or possible shortening of penile length. However, this difference was more notable when it came to patients who had required a plate incision during the surgical procedure due to the severity of the penile deformity.</p><p id="par0365" class="elsevierStylePara elsevierViewall">The satisfaction achieved by the patient and his partner after implantation is also influenced by the consistent use of postoperative rehabilitation exercises.<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17,18</span></a> Postoperative pain can favor the immobility of the organ and, consequently, the spontaneous development of postoperative inflammatory and scarring phenomena. This could all contribute to the lower satisfaction that patients showed in our study. This aspect, which has not been evaluated to any great extent in the literature, constitutes an important element for us. In fact, we urge patients to perform.</p><p id="par0370" class="elsevierStylePara elsevierViewall">Our work involves special preoperative consideration of these cases, with specific evaluation and discussion of potential expectations with patients and their partners. This helps in the decision-making process and even avoids subsequent medico-legal problems.</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Limitations</span><p id="par0375" class="elsevierStylePara elsevierViewall">Our study was carried out on patients and their partners using a questionnaire created by our team that was not validated in the general population. This fact, together with the presence of the patient's partner simultaneously, may qualify the generalization of the results. However, the number of cases and the time of case study can compensate for this problem, and the results are consistent with the specific literature.</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Conclusion</span><p id="par0380" class="elsevierStylePara elsevierViewall">After carrying out the survey on those patients who meet the requirements to enter the study and agree to participate, it is concluded that non-complex PD does not in itself determine lower satisfaction results in sexual relationships in patients and their partners compared to patients without PD. However, complex PE that requires additional surgical maneuvers to the implant may be related to worse satisfaction rates in sexual relations. Almost 50% of patients with complex PE and implant report a sensation of significant penile shortening after implantation and/or a sensation of low glans turgor. It is important to take these data into account in the preoperative interview with the patient and his partner, to provide and agree on adequate post-surgical expectations, and avoid conflicts and dissatisfaction with the treatment performed. It seems necessary to implement multicenter and prospective studies, with the use of validated and specific satisfaction questionnaires for this group of patients.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres2158310" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction and objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Material and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1831410" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2158311" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción y objetivos" ] 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" => "xpalclavsec1831409" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Objectives" ] 6 => array:3 [ "identificador" => "sec0015" "titulo" => "Material and methods" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Study design" ] 1 => array:2 [ "identificador" => "sec0025" "titulo" => "Study population and study period" ] 2 => array:2 [ "identificador" => "sec0030" "titulo" => "Inclusion criteria" ] 3 => array:2 [ "identificador" => "sec0035" "titulo" => "Exclusion criteria" ] 4 => array:2 [ "identificador" => "sec0040" "titulo" => "Sample size" ] 5 => array:2 [ "identificador" => "sec0045" "titulo" => "Study variables (Appendix 1)" ] 6 => array:2 [ "identificador" => "sec0050" "titulo" => "Material used" ] 7 => array:2 [ "identificador" => "sec0055" "titulo" => "Study population" ] ] ] 7 => array:3 [ "identificador" => "sec0060" "titulo" => "Results" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0065" "titulo" => "Results of the patient survey (Appendix 2, 3)" ] 1 => array:2 [ "identificador" => "sec0070" "titulo" => "Results of the survey of patients' partners (Appendix 4)" ] ] ] 8 => array:2 [ "identificador" => "sec0075" "titulo" => "Discussion" ] 9 => array:2 [ "identificador" => "sec0080" "titulo" => "Limitations" ] 10 => array:2 [ "identificador" => "sec0085" "titulo" => "Conclusion" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-07-05" "fechaAceptado" => "2023-08-19" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1831410" "palabras" => array:5 [ 0 => "Penile prosthesis" 1 => "Erectile dysfunction" 2 => "Sexual satisfaction" 3 => "Questionnaire" 4 => "Expectations" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1831409" "palabras" => array:5 [ 0 => "Prótesis de pene" 1 => "Disfunción eréctil" 2 => "Satisfacción sexual" 3 => "Cuestionario" 4 => "Expectativas" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction and objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Among the many treatments for erectile dysfunction, implantation of a penile prosthesis has been associated with high patient satisfaction rates. However, patients with coexistent Peyronie’s disease (PD) and refractory erectile dysfunction and/or severe deformities may show different results. The aim of our study was to assess and to compare the level of satisfaction, with an inflatable penile prosthesis (IPP), in men with/without coexistent PD.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Material and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A survey study based on a five-item satisfaction questionnaire was submitted to all those live patients implanted in the period 1992–2022 at our center (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>570) and their partners. Ninety-two percent of implants were inflatable devices. Surgeries were mainly performed by two surgeons. The main outcome measure used was the level of patient and partner satisfaction with sexual intercourse after IPP.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Of the 570 eligible patients, 479 (84%) completed the survey (393 Non-PD: GROUP 1; 70 non-complex PD-Group 2; 16 complex PD). Eighty-six per cent of patients in Group 1 reported satisfactory sexual intercourse (very or moderately satisfied). Non-complex PD implanted patients (Group 2) reported a global 81% satisfactory sexual intercourse (very or moderately satisfied) (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05). However, when we evaluated the PD subgroup of patients with severe PD who require incision/excision/grafting at the time of implant (Group 3: n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>20), only 61% reported satisfactory sexual intercourse (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01) with predominance of moderately satisfied patients over very satisfied: 78% vs. 22%). Additionally, 84% (Group 1), 80% (Group 2) and 54% (Group 3) of partners reported satisfactory intercourses, respectively (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01). Overall, 84% of Group 1 implants and 79% of Group 2 reported that they would undergo the procedure again if the IPP failed (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0.05; ns). Only 50% of Group 3 patients would do it again. With regard to cosmetic aspects, 48% of the Group 3 implant reported penile shortness or soft glans as the main causes of their dissatisfaction. Only 2.4% of total PP patients expressed difficulty in manipulating the device.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The presence of PD alone may not impact PP patient and partner satisfaction, but patients with more severe baseline deformity who require incision/grafting may be less satisfied with outcomes including penile length and glans sensation.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction and objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Material and methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusion" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducción y objetivos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Entre los muchos tratamientos para la disfunción eréctil, la implantación de una prótesis de pene se ha asociado con altos índices de satisfacción del paciente. Sin embargo, los pacientes con enfermedad de Peyronie (EP) coexistente y disfunción eréctil refractaria y/o deformidades severas pueden mostrar resultados diferentes. El objetivo de nuestro estudio fue evaluar y comparar el nivel de satisfacción con el implante de una prótesis de pene (PPI) en hombres con/sin EP coexistente y sus parejas.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Materiales y métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se administró un cuestionario de satisfacción de cinco ítems a todos aquellos pacientes vivos implantados en el periodo 1992–2022 en nuestro centro (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>570), así como a sus parejas. El noventa y dos por ciento (92%) de los implantes eran dispositivos inflables, de 3 componentes. Las cirugías fueron realizadas principalmente por dos cirujanos. Principales medidas de resultado: La principal medida de resultado utilizada fue el nivel de satisfacción del paciente y su pareja con las relaciones sexuales después de la IBP.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">De los 570 pacientes elegibles, 479 (84%) completaron la encuesta (393 No EP: GRUPO 1; 70 EP no complejos-Grupo 2; 16 TP complejos-Grupo 3). Ochenta y seis por ciento (86%) de los pacientes en el Grupo 1 reportaron relaciones sexuales satisfactorias (muy o moderadamente satisfechos). Los pacientes implantados de DP no complejos (Grupo 2) reportaron un 81% global de relaciones sexuales satisfactorias (muy o moderadamente satisfechas) (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>005). Sin embargo, cuando evaluamos el subgrupo de EP pacientes con EP grave que requieren incisión/escisión/injerto en el momento del implante (grupo 3: n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>20) solo el 61% reportó relaciones sexuales satisfactorias (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01) con predominio de moderadamente pacientes satisfechos sobre muy satisfechos: 78% vs. 22%). Además, el 84% (grupo 1), el 80% (grupo 2) y el 54% (grupo 3) de las parejas reportaron relaciones sexuales satisfactorias, respectivamente (p<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0,01). En general, el 84% de los implantes del grupo 1 y el 79% del grupo 2 informaron que volverían a someterse al procedimiento si fallaba el IBP (p<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>0,05; ns). Solo el 50% de los pacientes del grupo 3 lo volvería a hacer. Con respecto a los aspectos estéticos, el 48% de los implantes del grupo 3 reportaron acortamiento del pene o sensación de glande blando/frío como las principales causas de su insatisfacción. Solo el 2,4% del total de pacientes con PP expresó dificultad para manipular el dispositivo.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">La presencia de EP por sí sola puede no afectar la satisfacción del paciente con PP y su pareja, pero los pacientes con una deformidad inicial más grave que requieren incisión/injerto pueden estar menos satisfechos con los resultados, incluida la longitud del pene y la sensación del glande.</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción y objetivos" ] 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:3 [ "etiqueta" => "1" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">In memoriam.</p>" "identificador" => "fn0005" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0390" class="elsevierStylePara elsevierViewall">The following is Supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>" "etiqueta" => "Appendix A" "titulo" => "Supplementary data" "identificador" => "sec0095" ] ] ] ] "multimedia" => array:1 [ 0 => array:5 [ "identificador" => "upi0005" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc1.docx" "ficheroTamanyo" => 637123 ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "European Association of Urology guidelines on sexual and reproductive health—2021 update: male sexual dysfunction" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "A. 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