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      Surgical Outcomes and Patient Satisfaction With the Low-Cost, Semi-Rigid Shah Penile Prosthesis: A boon to the Developing Countries

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          Abstract

          Introduction

          In developing countries most patients with refractory erectile dysfunction cannot afford a penile prosthesis (PP) due to its cost and non-coverage by insurance companies.

          Aim

          To assess the patient satisfaction outcomes with a novel, low-cost, semi-rigid PP.

          Methods

          52 patients who had received the Shah semi-rigid PP between January 2013 and December 2018 were included in this bidirectional study. Patient demographics including age, etiology, body mass index, length of PP received and post-operative complications were recorded. Patient satisfaction with the PP was evaluated using the modified Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire.

          Main outcome measures

          The primary outcome measures were overall satisfaction, total EDITS and mean EDITS score. The secondary outcome measures were residual penile tumescence, ease of concealment and post-operative complications.

          Results

          The mean age of the patients was 38.79 years (25–68). Overall satisfaction (EDITS Q-1) of 4 (0–4) was reported by 84.62% (44/52) of patients. There was no significant difference ( P > .7) in the total EDITS and overall satisfaction based on various etiological factors. The mean EDITS scores (0–100) were 95.67 ± 10.76, 95.53 ± 8.46 and 91.72 ± 22.42 in 52 patients with BMI <25, 25–29.9 and >30 kg/m2 respectively. During sexual arousal after PP implantation, 26 (50%), 17 (32.7%) and 9 (17.3%) patients noted “good”, “some” or “no” residual penile tumescence respectively. 47 (90.4%), 4 (7.7%) and 1 (1.9%) patients reported “good”, “fair” and “poor” concealment respectively. In the prospective group, major and minor post-operative complications were seen in 10.7% (3/28) and 21.4% (6/28) of patients respectively.

          Conclusion

          The semi-rigid Shah PP is a safe, effective and affordable option to treat patients with refractory ED. The ability to remove 1 or both sleeves in the Shah PP helps achieve a good fit with a small inventory. Krishnappa P, Tripathi A, Shah R. Surgical Outcomes and Patient Satisfaction With the Low-Cost, Semi-Rigid Shah Penile Prosthesis: A boon to the Developing Countries. Sex Med 2021;9:100399.

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          Most cited references21

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          EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction.

          To develop Patient and Partner versions of a psychometrically sound questionnaire, the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), to assess satisfaction with medical treatments for erectile dysfunction. Treatment satisfaction differs from treatment efficacy as it focuses on a person's subjective evaluation of treatment received. Twenty-nine items representing the domain of treatment satisfaction for men and 20 representing partner satisfaction were generated. Two independent samples of 28 and 29 couples completed all items at two points in time. Spearman rank-order correlations were derived to assess test-retest reliability and couple coefficients of validity. Internal consistency coefficients were calculated for both Patient and Partner versions and a content validity panel was used to analyze content validity. Only items that met all the following criteria were selected to comprise the final questionnaires: (a) range of response four or more out of five; (b) test-retest reliability greater than 0.70; (c) ratings by at least 70% of the content validity panel as belonging in and being important for the domain; and (d) significant correlation between the subjects' and partners' responses. Eleven patient items met criteria and formed the Patient EDITS; five partner items met criteria and formed the Partner EDITS. Scores on the two inventories were normally distributed with internal consistencies of 0.90 and 0.76, respectively. Test-retest reliability for the Patient EDITS was 0.98; for the Partner EDITS, it was 0.83. Reliability and validity were well established, enabling the EDITSs to be used to assess satisfaction with treatment modalities for erectile dysfunction and to explore the impact of patient and partner satisfaction on treatment continuation.
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            Determinants of patient satisfaction following penile prosthesis surgery.

            Penile prosthetic surgery is associated with satisfaction rates >90% for the general penile implant population. It is suggested that satisfaction rates may be lower in certain populations. This study was undertaken to define potential predictors of satisfaction. Patients undergoing penile prosthesis surgery completed the International Index of Erectile Function (IIEF) prior to surgery, and the IIEF and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaires at least 6 months postoperatively accompanied by a Global Satisfaction Question (GSQ). A total of 114 patients constituted the study population. Subgroups evaluated included patients with Peyronie's disease (PD), body mass index (BMI) > 30 kg/m2, radical prostatectomy (RP), and patient age > 70 years. The mean patient age and duration of ED were 59 +/- 14 and 3.2 +/- 1.9 years, respectively. All groups demonstrated statistically significant differences between pre- and postoperative scores for the IIEF and EDITS. Patients with PD, a history of RP, and BMI > 30 kg/m2 had significantly lower scores on the GSQ, IIEF satisfaction domain, and EDITS compared with the general implant population. Only PD impacted negatively on the postoperative IIEF erectile function domain score. On the multivariate analysis, factors associated with >or=5-point difference in the IIEF satisfaction domain score compared with the general implant population were PD (RR = 4.2), RP (RR = 2.2), and BMI > 30 (RR = 1.8). These data suggest that men diagnosed with PD, BMI > 30, or previous RP undergoing penile prosthesis surgery have lower satisfaction rates than the general penile implant population.
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              Penile implantation in Europe: successes and complications with 253 implants in Italy and Germany.

              Results for prosthesis implantation from everyday clinical practice within Europe are few. This report provides data on the most commonly used penile prostheses (the American Medical Systems [AMS] series). The study aimed to assess, retrospectively, complications and patient satisfaction with AMS penile implants in 253 consecutive patients with erectile dysfunction from three European centers. Pre, intra- and postoperative data were obtained from chart review, with a mean follow-up of 60 months; 200 patients were available for evaluation. Patient satisfaction data were collected using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Complications and patient satisfaction were assessed. Patient satisfaction was evaluated using a standardized assessment tool (the modified EDITS questionnaire). Major postoperative complications occurred in 40 (20%) patients, including 9 (22.5%) prosthesis infections, 18 (45%) mechanical failures, and 13 (32.5%) erosions. Patient satisfaction with the AMS 700CX, AMS Ambicor, and AMS 600-650 was 97%, 81%, and 75%, respectively; dissatisfaction was 0%, 5%, and 6%, respectively. Partner satisfaction with the AMS 700CX, AMS Ambicor, and AMS 600-650 was 91%, 91%, and 75%, respectively; dissatisfaction was 0%, 5%, and 6%, respectively. Erections were more natural (harder) than before with the AMS 700CX, AMS Ambicor, and AMS 600-650 in 91%, 85%, and 88%, respectively; hardness was the same as before in 9%, 15%, and 13%, respectively; no erections were less hard than before. Postoperative complications differed from those reported in the literature, while patient satisfaction rates were roughly similar. The reporting of specific data for different implant types, plus the use of standardized assessment tools for patient satisfaction is significant as in the future, it will allow comparison of data between centers performing penile prosthesis implants using these devices.
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                Author and article information

                Contributors
                Journal
                Sex Med
                Sex Med
                Sexual Medicine
                Elsevier
                2050-1161
                16 July 2021
                August 2021
                16 July 2021
                : 9
                : 4
                : 100399
                Affiliations
                [1 ]Division of Andrology, Department of Urology, NU Hospitals, Bangalore, India
                [2 ]Division of Andrology, Department of Urology, Lilavati Hospital and Research Centre, Mumbai, India
                Author notes
                [* ] Corresponding Author: Pramod Krishnappa DNB, Division of Andrology, Department of Urology, 4/1, West of chord road, Rajajinagar, Bangalore, Karnataka 560010, India. Tel: 080-42489999 Pramod23dr@ 123456gmail.com
                Article
                S2050-1161(21)00079-9 100399
                10.1016/j.esxm.2021.100399
                8360909
                34274823
                a3512901-5c1f-494a-ac28-76398d846c38
                Copyright © 2021 The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine.

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                : 12 February 2021
                : 4 June 2021
                Categories
                Original Research
                Surgery

                shah penile prosthesis,semirigid penile prosthesis,erectile dysfunction,edits,residual penile tumescence

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