Cavernous tissue preservation technique versus conventional technique during penile prosthesis implantation: a prospective comparative study

Erectile dysfunction, defined as the inability to attain or/and maintain an erection sufficient for satisfactory sexual performance[13].The most important end-point of PPI surgery is to achieve the highest patient and partner satisfaction with the lowest complication rates[14]. Although the satisfaction rates have been well studied, the factors affecting the satisfaction levels post PPI have not been well-studied [15].

To our knowledge, few prospective studies compare between conventional and cavernous sparing techniques in PPI. Therefore, in this study we aimed to compare between both techniques along with analyzing the factors affecting male satisfaction rates after PPI.

Our study is a prospective clinical study included 60 patients, with severe ED. In this series, median age was 55 years, with a range of (30–67). While In a study done by Chung et al.(2013) [16], the median age for penile prosthesis implant was 53 years (range from 28 to 80 ys), and in another study done by Dhabuwala et al. (2011) [17], the median age for penile prosthesis implant was 61 years (range from 35 to 85 ys). In both studies, there is significant difference in the maximum age in comparison with our study mainly due to decrease in life expectancy in our developing country, which is below (75 y). The duration of ED before surgery ranged from (1–10) years with a median of 6 years which is similar to study done by Ibrahim et al. (2015) [18], that reported a median duration of 6.6 years. In our study, we did not observe an association between the duration of ED before PPI and the male satisfaction rates post PPI that is in agreement with others [18].

In our study there were multiple risk factors and etiology of ED the most prevalent of them was smoking, 36 patients (60.0%), this agrees with study done by RM Seyam et al. (2017) [19] in which ED was directly associated with smoking cigarettes or tobacco (P > 0.005). Long- term cigarette smoking is a major risk factor for development of vasculogenic ED because of its effects on the vascular endothelium and the prevalence of severe ED among heavy smokers is 19.6% [20].

In our study all patients experienced medical treatment in the form of oral sildenafil and (38.4%) of patients had home ICI therapy after failure of oral sildenafil treatment but also failed, while vacuum device was used by the fewest number of patients, which is consistent with the data obtained from study done by Salama et al. (2004) [21]. While in the study done by Nguyen HMT et al. (2017) [22], (52.5%) of total 139 patients had used oral medication for ED before surgery, and (31.7%) of total 139 patients had used ICI injections.

The Sexual Health Inventory for Men (SHIM) is a widely used scale for screening and diagnosis of erectile dysfunction (ED) and severity of ED in clinical practice and research. Using SHIM score criteria all patients (100%) in this study were ≤ 6 and mean score was 5 as all patients subjected to the implant surgery had severe ED, similar to result of study done by others [23] with a mean score preoperatively of 5.2.

As regard ICI diagnostic test sixty patients has been subjected to ICI test, ICI response was ≤ 3, and reached grade 4 only in 15 patients who had venous leakage with very rapid detumescence, similar to result of study done by other authors [24] in which up to 20% of patients with normal response (full rigid erection) were affected by arterial insufficiency as showed by penile Doppler ultrasound studies.

According to the results of the penile duplex obtained in our study, all patients (100%) were diagnosed as having vasculogenic ED (41 patients venogenic ED and 19 patients with arteriogenic ED) in comparing with the data base obtained from Song WD, et al. (2013) [25], 70% of patients are vasculogenic and with the study done in china by others [26] on 40 patients, there were 35 cases with neurogenic ED, the rest included five cases with venous leakage. This explains the concept of penile prosthesis that was accepted in patients with neurogenic ED in the previous study, as most of the patients were neurogenic.

In our study, operative time ranged (50–120) minutes, mean time was (60) minutes, operative time was prolonged mainly with Peyronie’s disease, ranged (90–120 min), and the difference in comparison with other risk factor was statistically significant (P value = 0.001). This can be explained by slow and careful blunt dilatation to expand the corpora cavernosa via standard corporotomy incision in order to avoid undesirable complication [27], while in another study [18], the mean operation time was 46.6 ± 10.9 in malleable penile prostheses group.

In this study, there was no significant difference in the preoperative median stretched penile girth between the 2 groups (10.80 vs 10.50 cm), while the postoperative mean penile girth was significantly improved in both study groups from pre-operative, 11.25 cm with range (9.50–12.60) cm, (p =  < 0.001), similar to result of another study [28], the postoperative mean penile girth was significantly thicker post penile prosthesis insertion (9.79 ± 1.11 cm). This girth preservation renders the penis more aesthetic and makes it more natural after surgery. This point could potentially decrease the demand for further postoperative girth-enhancing procedures often requested by patients by undergoing either silicone implantation or fat injection.

Regarding satisfaction post-operative with different operative steps during penile prosthesis implantation Conventional group or cavernous tissue sparing, there was no significant difference between two groups in male satisfaction rates post PPI, and this differ with results that reported by other authors[29], due to decrease in sample size in this study.

In our study, there was significant difference between two groups concerning spontaneous penile tumescence, In the cavernous tissue-sparing group, 26 of 30 patients (86.6%) reported having a significantly higher incidence of residual penile tumescence versus 2 of 30 patients (6.6%) in the conventional surgery group (P < 0.001) which is in agreement with the results of the study by Zaazaa A, et al. (2019) [28].

Intra-operatively we detected one case of distal Crossover, and two cases of perforation, and these complications only occurred with patients with Peyronie’s disease. We managed these complications intra-operatively successfully these results were comparable to the study by others[18] in which there were corporeal crossover (5 in MPP, 2 in IPP), corporeal perforation (1 in MPP, 3 in IPP) and urethral perforation (1 in MPP,1 in IPP). As regard post-operative superficial infection occurred in 5 patients of total 60 (8.3%), and managed successfully, three patients with superficial infection were diabetic, and may be also referred to lack of personal hygiene of the patients, ignorance to post-operative instruction as antibiotic dosage, early sexual intercourse in the 1st couple weeks. The incidence of infection was relatively higher than the data base obtained by some authors [29], in which infection occurred in 8 patients of total 100 (8%), while in a study done by other authors [17] from 81 patients, 8 patients developed infection (4.4%) two of the eight patients were diabetic and one of these two was also on corticosteroid therapy for control of thrombocytopenia. Hematoma is another complication associated with an increased risk of infection. It usually presents in the early postoperative period, with an incidence ranging from 0.2 to 3.6%) [30]. Regarding Post-operative oedema & hematoma detected in this study 7 patient, three patients had DM and peyronie’s, two had peyronie’s disease only, all cases managed conservatively without operative intervention, while in another study [31], only one case (0.8%) hematoma developed postoperatively, requiring operative evacuation, while in another study[32] hematoma developed in 2(1.1%) cases and treated conservatively.

As regard penile floppy glans during intercourse occurred only in 2 patients, these nearly the same in comparison with the study done by other authors [32] in which penile penile floppy glans during intercourse was reported in 4(2.2%) patients.

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Patient satisfaction was evaluated using modified EDITS, which is a standardized assessment tool adapted to PP devices. EDITS is a validated questionnaire developed by Althof, et al. (2000) [33] to assess satisfaction following medical ED treatment.

In this study, there is gradual increase in patients’ satisfaction by EDITS from 3 months, 6 months and 12 months in two groups. In Conventional group Very satisfied patient at 3 months 1 patient (3.3%) while in 6 months 6 patients (20%) while in 12 months 19 patients (63.3%). while in cavernous tissue sparing group Very satisfied patient at 3 months 0 patient (0.00%) while in 6 months 8patients (26.6%) while in 12 months 25 patients (83.3%). So, there is no significant difference between the two groups in postoperative satisfaction as measured by the EDITS questionnaire at 3, 6, and 12 months (p = 0.848, 0.733, and 1.000, respectively).

While post-operative mean EDITS score using the Modified Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire after 3,6, and 12 months was 76.9 ± 18, 79 ± 17 and 82.3 ± 16 respectively. while in another study [34], mean EDTIS score at 3,6, and 12 months was 58 ± 11,63 ± 9, and 81 ± 7 respectively, in comparing with the data base reported by some authors [35],overall mean EDTIS score being 77.1% and 75.6% for Genesis and Spectra malleable prostheses respectively, also using the EDITS questionnaire for patients with Spectra malleable prosthetic implants and their partners, another study [36], found a satisfaction rate of 86.4% in patients. The use of either a non-validated questionnaire or a tool developed in a non-PPI population could lead to an improper estimation of patient satisfaction. Indeed, with both strategies, we could miss the evaluation of some relevant aspects dealing with QoL, such as the relationship with the partner, as well as functional aspects, such as device operability and simplicity of use, which are all relevant to penile prosthesis surgery [37].

To provide a reliable tool able to simultaneously evaluate perceived penile prosthesis function and postoperative QoL, Caraceni and Utizi (2014) [38] designed the QoLSPP questionnaire, a validated questionnaire that specifically examined patient’s quality of life after PPI and the extent to which a penile prosthesis affects the patient’s sexual quality of life (SQoL). The main outcome measure of the QoLSPP is quality of life as biological and psychosocial-relational well-being after penile prosthesis placement. It has 16 questions encompassing 4 domains investigating: prosthesis function (functional); relationship with partner (relational); relation to the outside world (social); and self-image (personal) [38].

In this study, according to satisfaction using Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire after 6 months reported that high satisfaction 47 patients (78.3%) patients and Less satisfaction in 13 patients (21.6%), similar to study done by others[14] found some patients with low levels of QoL (10 patients with mean item scores < 2, 14.9%). On the other hand, 85.1% of patients reported high levels of satisfaction for the QoLSPP item regarding prosthesis function. This distribution might be due to some patients still having mental anguish connected to the feeling of impotence even though the prosthesis function is fine.

Regarding to factors affecting male satisfaction rates after PPI in our study the median age of highly satisfied subjects was 55.00 years, with range (30.00–65.00), while the median age of less satisfied subjects was 58.00 years, with range (45.00–67.00). The age of highly satisfied subjects was significantly lower than those less satisfied (p < 0.010).

So that, in this study the age of the patient has an effect on his satisfaction rates post PPI, thus confirming studies that have reported that they have observe an association between age and patient satisfaction, even after using a questionnaire specifically investigating the simplicity of use of the implanted device[39].

In another study [40], there were 45 patients (64%) who were younger than 65 years and all of them reported to be almost or very satisfied by the 2-piece IPP function, belonging the low rate of dissatisfaction only to patients older than 65 years, which could be explained by the lower expectations among elder patients.

Regarding to other factors affecting male satisfaction rates after PPI other authors [19] reported that a BMI > 30 kg/m2 has been associated with dissatisfaction after penile prosthesis surgery. This also has been shown through lower EDITS scores in this group compared with the general population, similar to results in this study, there is a positive relationship between BMI and satisfaction. Patients with high satisfaction BMI ≤ 24.5 kg/m2, while less satisfaction BMI > 30 kg/m2, so The BMI of highly satisfied subjects was significantly lower than those less satisfied (p < 0.001). Some data indicate that obese patients have a higher risk for ED than those with a normal BMI (≤ 25 kg/m2) because of abnormal endothelial function and psychological factors Thus, obese patients might harbor lower satisfaction at baseline before penile implantation that could explain lower postoperative satisfaction [41].

Regarding to risk factors we observed that 34 diabetic subjects, 23 (51.1%) subjects were highly satisfied and 11 (31.7%) were less satisfied complications on male satisfaction rates post PPI, significant difference was found between highly satisfied and less satisfied subjects regarding the frequency of DM (p < 0.022). These results are in agreement with the results of another study [39].

Regarding to etiology of ED and relation of this with satisfaction, 19 subjects with arterial insufficiency, 15 (31.9%) subjects were highly satisfied and 4 (30.8%) were less satisfied. While 41 subjects with venous leakage 32 (68.1%) subjects were highly satisfied and 9 (69.2%) were less satisfied. No significant difference was found between highly satisfied and less satisfied subjects regarding the frequency of arterial insufficiency or venous leakage (p = 0.937). These results are in agreement with the results of the study by other authors [39].

Our study has limitations: the small sample size and usage of only one type of penile prostheses (malleable) due to the financial aspect of implant surgery; these may be the subject of other researches to avoid these points and limitations.

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