Stesura Seveso Archivio Italiano di Urologia e Andrologia 2024; 96(3):12613 1 ORIGINAL PAPER have been associated with an increased risk of morbidity and mortality in males with ESRD (5, 6). Kidney transplantation (KT) has been reported to improve sexual function and sex hormone profiles (7-10). However, there are few studies concerning serum pitu- itary-gonadal hormones and sexual dysfunction during dialysis and post-KT in Saudi populations. This study aimed to evaluate sex hormonal profile and sexual function status in patients with erectile dysfunction (ED) after two treatment modalities for ESRD, including KT and peritoneal/hemodialysis (PD/HD) in Southern Saudi Arabia. PATIENTS AND METHODS A non-concurrent cohort study included ESRD patients associated with ED after two treatment modalities, including KT and peritoneal/hemodialysis (PD/HD). The study was conducted at the Armed Forces Hospitals Southern Region, KSA, from September 2017 to January 2023. The local institutional ethical committee approved the protocol, and all enrolled patients signed an informed consent form. Inclusion criteria The study included all married male patients with ED associated with ESRD aged 18-60; in group A, 40 and 10 patients were on HD and PD, respectively. In group B, all patients underwent KT between September 2017 and September 2023 and had stable graft function. Exclusion criteria Primary hypogonadism, hemochromatosis, history of cancer treatment (chemotherapy and radiotherapy), pitu- itary tumors, hypopituitarism of any etiology, and inflam- matory diseases such as tuberculosis and sarcoidosis. Moreover, patients having second KT, rejection within three months after transplantation, unstable postopera- tive graft function with serum creatinine over 20 mg/L, and sirolimus as part of the immunosuppressive regimen. Background: Erectile dysfunction (ED) and sex hormone profile disturbances are com- mon in ESRD patients. Objective: To assess the effect of kidney transplant (KT) and Hemodialysis/peritoneal dialysis (HD/PD) on the serum sex hormone profile and sexual functions in ESRD patients with ED. Patients and methods: A single-center, non- concurrent cohort study included a hundred ESRD patients with ED, on regular HD/PD (group A, n = 50) and after KT (group B, n = 50) at Armed Forces Hospitals Southern Region, KSA. Results: the mean age of patients was 47.3 ± 7.01 and 56.8 ± 9.6 years in groups A and B, respectively. The cohorts were compa- rable regarding patient demographics, apart from a higher inci- dence of comorbidities in group B. After KT the mean testos- terone level was higher in Group B (13.64 ± 3.21 nmol/L Vs 10.26 ± 3.26 nmol/L, p < 0.001). Similarly, LH and prolactin levels were lower in group B than in group A (p < 0.05). As regards sexual function, ED was reported in 92% of patients in group A compared to 42% in group B (p < 0.001). In groups A and B, mild ED was found in 48% and 14% of patients, while moderate ED was found in 16% and 8%, respectively. The mean total IIEF-15 score was 36.42 ± 9.33 and 43.87 ± 9.146 in groups A and B, respectively (p = 0.0001). Sexual desire and orgasm were significantly better in Group B. Conclusions: Our study showed that kidney transplantation could improve erectile function and restore normal sex hormone levels in ESRD male patients with ED, with better outcomes compared to HD/PD. KEY WORDS: Sex hormones profile; Erectile dysfunction; Kidney transplantation. Submitted 27 April 2024; Accepted 13 June 2024 INTRODUCTION Hormonal disturbances such as luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin increase, and decreased testosterone levels are associated with End- stage renal disease (ESRD) (1-3). These hormonal changes may lead to sexual dysfunction, especially disorder in sexual arousal (4). In addition, low testosterone levels Kidney transplantation restores sex hormone profile and improves sexual function in ESRD patients with erectile dysfunction Hany M. El Hennawy 1, Omar Safar 2, Abdullah S. Al Faifi 1, Osama Shalkamy 2, 3, Mahmoud Z. El Madawie 2, Saad Thamer 2, Muath Almurayyi 2, Abdullah Mohammed Alqarni 4, Sami Saleh Amri 4, Ali Abdullah Hawan 4, Adel Elatreisy 3, 5 1 Surgery Department, Section of Transplantation, Armed Forces Hospitals Southern Region, Khamis Mushayte, 101, Saudi Arabia; 2 Urology Department, Armed Forces Hospitals Southern Region, Khamis Mushayte, 101, Saudi Arabia; 3 Urology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt; 4 Laboratory Department, Armed Forces Hospitals Southern Region, Khamis Mushayte, 101, Saudi Arabia; 5 Urology Department, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia. DOI: 10.4081/aiua.2024.12613 Summary Archivio Italiano di Urologia e Andrologia 2024; 96(3):12613 H.M. El Hennawy, O. Safar, A.S. Al Faifi, O. Shalkamy, et al. 2 In addition, patients receiving medication or herbal com- pounds to restore erectile function or underwent testos- terone replacement therapy. During the pre-kidney transplant (KT) evaluation, 50 patients presenting with ED were selected from the urol- ogy clinic (Group A). In comparison, an additional 50 patients with ED were chosen from the dialysis unit (Group B) based on predefined inclusion and exclusion criteria. In all transplanted patients, the kidney graft was placed extraperitoneal in the right/left iliac fossa, the renal artery was anastomosed to the common or external iliac artery, and the vein was anastomosed to the common or external iliac vein. The ureter was anastomosed to the recipient’s bladder using the Lich-Gregoire technique over a double- J ureteric stent. We usually remove the ureteric stent after six weeks. Immunosuppression for all patients consisted of a triple regimen including tacrolimus, mycophenolate mofetil or mycophenolic acid, and prednisolone. All patients were subjected to a complete medical history through medical examination and routine laboratory investigation. In addition, gonadal hormone levels (LH, FSH, free Testosterone, prolactin [PRL]) and the International Index of Erectile Function (IIEF5-15) ques- tionnaire were assessed pretransplant and 6 months after renal transplantation. Major drugs causing ED, such as beta-blockers, alpha-blockers, spironolactone, and thi- azide diuretics, were withdrawn six months before start- ing the study. Measurements Serum pituitary-gonadal hormones were measured as follows: All blood samples were drawn in the morning (7.00-9.00 a.m.) after an overnight fast (12 h). Venous blood samples of the patients with ED were collected during dialysis and 1-2 and 3-4 months postoperatively, respectively. Serum pro- lactin (PRL), follicle-stimulating hormone (FSH), LH, and testosterone levels were measured immediately by electrochemiluminescence immunoassay (Elecsys System, Roche Diagnostics GmbH, Mannheim, Germany) according to the manufacturer’s instruc- tions. All blood samples were measured in dupli- cate (11). Moreover, we reported sexual activity after trans- plantation, sexual desire, degree of erection, satis- faction with sexual activities, frequency of sexual activities, and IIEF5-15 score for all patients. Comparison between the study groups included patient demographics, sex hormone levels, and sexual function status. Statistical analysis We analyzed the data using the Statistical Package for Social Science (SPSS) software, version 29 (SPSS Inc., Chicago, IL). We presented the numeric vari- ables as a mean and standard deviation, while cat- egorical variables were presented as a frequency and percentage. We tested the association between nominal variables using the chi-square test. At the same time, the Student’s t-test was applied to define the difference between the means of contin- uous variables for different groups. We used the Mann- Whitney U test to compare the ordinal variables in two groups. A paired-sample t-test was used to detect the sig- nificance level between pre-transplant and post-trans- plant values. RESULTS Group A included 50 patients with ED on HD/PD, and Group B included 50 patients with ED who underwent living-related donor KT. The cohorts were comparable in terms of patient demo- graphics, including smoking history, duration of peri- toneal/hemodialysis, and body mass index. Nevertheless, the prevalence of comorbidities, including diabetes melli- tus, hypertension, ischemic heart disease, and dyslipi- demia, was significantly higher in group B, as shown in Table 1. The median duration of peritoneal/hemodialysis in Group A was 4 years, while the median duration of hemodialysis before KT in Group B was 2 years, with an average of (4 and 3 years), in Groups A and B, respec- tively Table 1. Table 2 displays the serum sex hormone levels for the study groups at 6-month follow up after KT.. In group A, FSH, Prolactin, and LH levels were significantly higher, and serum testosterone levels were significantly lower than average range values. The mean testosterone level was 13.64 ± 3.21 nmol/L in group B compared to 10.26 ± 3.26 nmol/L in group A with a statistically significant difference (p = 0.0001). Similarly, LH and prolactin lev- Table 1. Demographic data of the study groups. Parameter Group A Group B p-value (Dialysis patients = 50) (KT patients, n = 50) Total (n) patients 50 50 Age in years, Mean ± SD 47.32 ± 7.013 56.87 ± 9.612 0.0001 DM, % (N) 22% (11) 100% (50) 0.00001 HTN, % (N) 100% (50) 100% (50) N/A IHD, % (N) 6% (3) 54% (27) 0.00001 Dyslipidemia, % (N) 22% (11) 72% (36) 0.00001 PVD, % (N) 0% (0) 18% (9) 0.00001 Smoking, % (N) 18% (9) 28% (14) 0.234 Neuropathy, % (N) 0% (0) 0% (0) N/A Psychological disease, % (N) 0% (0) 0% (0) N/A Cause of ESRD, % (N) 0.00001 DM 22% (11) 8% (4) HTN 76% (32) 28% (14) DM, HTN 14% (7) 64% (32) Mood of dialysis, % (N) N/A PD 20% (10) 0% (0) HD 80% (40) 100% (50) Previous Transplant 2% (n = 1) 0% (0) N/A Duration of peritoneal/hemodialysis before KT, median (IQR) in years 4 (4) 2 (3) N/A BMI, Mean ± SD 24.68 ± 1.42 24.41 ± 3.62 0.630 Follow up serum creatinine mean ± SD in µmol/L 976.96 ± 204.1 83.26 ± 19.44 0.0001 Archivio Italiano di Urologia e Andrologia 2024; 96(3):12613 3 Kidney transplantation and sexual function els were lower in group B than in group A (p < 0.05). There was no significant difference in the FSH levels, as shown in Table 2. As regards sexual function, ED was reported in 92 % of patients in group A compared to 42% in group B (p < 0.001). In groups A and B, mild ED was found in 48% and 14% of patients, while moderate ED was found in 16% and 8%, respectively, as detailed in Table 3. In group A, the mean IIEF5-15 score was 18.4/30 ± 5.4 (range, 7-30), and the mean total IIEF-15 score was 46.8/75 ± 12.7 (range, 19-75). In group B, one year after successful KT, the mean IIEF5-15 score was significantly higher than group A; it was 22.3 ± 5.7 (p < .001). Similarly, the mean total IIEF-15 score was 55.5 ±13 (p < .001), as depicted in Table 4. Sexual desire and orgasm were significantly better in Group B compared to Group A; similarly, sexual inter- course satisfaction and overall patient sexual satisfaction were significantly higher in Group B, as demonstrated in Table 4. In group B, patients who had improved erectile function post-transplant (n = 34), mean serum testosterone level increased by 48% compared with an 18% increase in patients who reported no change in erectile function (n = 16) (p = 0.001). DISCUSSION Erectile dysfunction is defined as the persistent incapability to attain or maintain a penile erection sufficient for satisfactory sexual activity. In end- stage renal disease, incidence is 50-70% (2). Significant hormonal changes, such as LH, FSH, and prolactin elevation, as well as declines of testos- terone and anti-Müllerian hormone (AMH) levels, are the most prominent effects of a decrease in kidney function levels (3, 8). Likewise, our study found similar changes in sex hormone levels in dialysis patients (Table 3). Total testosterone was inversely associated with ED after adjusting for SHBG. Men with both low free testosterone and high SHBG had the highest ED risk (12-14). In addition, high testosterone levels independently predicted a decreased risk of ED in young men (12). Moreover, the duration of dialysis was more than fifty months, and the FSH level was higher in sub- jects with longer period of dialysis than that in those dialyzed for a shorter period or not dialyzed (15). Hyperprolactinemia commonly occurs in CKD, with a prevalence of 30-65% (16) due to declines in excretion and to increased synthesis (17). Clinical features may include ED, decreased libido, infertility, gynecomastia, and reduced skeletal mass (18). cardiovascular events in men with ED are associated with elevated plasma prolactin levels (17, 18). In addition, the impairment of testicular function seen in advanced uremia is not reversible by main- tenance hemodialysis (19). Several studies have demonstrated restoration of pituitary-gonadal axis dysfunction and improved hormonal profile, clinical sex- ual profile, and fertility after KT (11, 20, 21). It was found that pituitary-gonadal function was nearly restored to the normal range in most recipients about four months post- KT (3, 12). Similarly, in our study, normal sex hormone levels were restored within six months post-KT.Our study reported that serum testosterone levels were higher in the post-KT group in association with lower plasma prolactin and LH levels. There was no noticeable differ- ence in plasma FSH levels between the two groups. These results are comparable to the findings of Rahman et al. (22). In agreement with several studies (23), during the serial baseline and follow-up assessments, we discovered a significant increase in testosterone levels in the post-KT (p < 0.008). Furthermore, serum testosterone levels were restored to the normal range 3-4 months post-KT in male recipients. Consequently, sexual activities and IIEF-15 scores improved markedly post-KT (11, 22). Similarly, our study restored total testosterone levels within six months after KT. In our study, we found that patients Table 2. Comparison in Sex Hormones serum levels between the study groups. Serum levels of sex hormones Group A Group B p-value Mean ± SD (Dialysis patients = 50) (KT patients, n = 50) Before Kidney transplant • Testosterone (nmol/L) 10.25 ± 3.32 10.11 ± 3.23 0.76 • LH (mIU/ml) 15.52 ± 17.56 15.87 ± 4.81 0.58 • FSH (mIU/ml) 11.08 ± 20.21 11.9 ± 12.96 0.98 • Prolactin (ng/ml) 23.98 ± 16.46 23.22 ± 1.71 0.26 6 months After Kidney transplant • Testosterone (nmol/L) 10.26 ± 3.26 13.64 ± 3.21 0.0001 • LH (mIU/ml) 15.49 ± 17.64 5.66 ± 4.76 0.0001 • FSH (mIU/ml) 11.11 ± 20.39 11.07 ± 13.95 0.993 • Prolactin (ng/ml) 24.12 ± 16.57 9.19 ± 1.63 0.0001 Table 3. Degree of erectile dysfunction in the study groups. Serum levels of sex hormones Group A Group B p-value Mean ± SD (Dialysis patients = 50) (KT patients, n = 50) No ED 4 (8%) 29 (58%) <0.001 Mild ED 24 (48%) 7 (14%) Mild to moderate ED 10 (20%) 9 (18%) Moderate ED 8 (16%) 4 (8%) Sever ED 4 (8%) 1 (2%) Table 4. The IIEF-15 score in transplant group before & after transplant. The score Group A Group B p-value Mean ± SD (Dialysis patients = 50) (KT patients, n = 50) IIEF5-15 (ED) 13.94 ± 3.941 17.03 ± 3.719 0.0001 IIEF 9-10 (orgasm) 4.90 ± 1.469 5.84 ± 1.369 0.001 IIEF 11-12 (sexual desire) 5.10 ± 1.62 5.81 ± 1.515 0.026 IIEF 6-8 (intercourse satisfaction) 7.42 ± 2.233 9.16 ± 2.311 0.0001 IIEF 13-14 (overall satisfaction) 5.06 ± 1.526 6.03 ± 1.581 0.002 Total IIEF-15 score 36.42 ± 9.330 43.87 ± 9.146 0.0001 Archivio Italiano di Urologia e Andrologia 2024; 96(3):12613 H.M. El Hennawy, O. Safar, A.S. Al Faifi, O. Shalkamy, et al. 4 with an increase in the IIEF score post-KT showed a rise in mean testosterone levels by 48% compared with an 18% increase in patients with a decrease in the IIEF score post-KT (P = 0.366). This corresponds to an increase in potency. During the serial baseline and follow-up assess- ments, we discovered a significant decrease in prolactin levels in the post-KT group (p 0.006) compared with the other group. Similarly, in a study by Reinhardt et al., they reported that prolactin levels fell immediately post-KT and were constant until the end of follow-up (10). Our findings contradicted those of Sikora-Grabka et al. (24), who found that both LH and FSH levels decreased sig- nificantly during the observation period. Successful KT could improve gonadal function, but immunosuppressive medications could also impair it. It remains controversial whether KT could improve gonadal, sexual, and repro- ductive functions, especially in the long follow-up (11). Glucocorticoids affect gonadal function at several levels in the hypothalamic-pituitary-gonadal axis: 1) decreasing the release and synthesis of GnRH by the hypothalamus; 2) decreasing the release and synthesis of LH and FSH by the pituitary gland; 3) modulating of steroidogenesis and/or gametogenesis directly by the testis/ovary (25). Furthermore, several studies found that plasma testos- terone levels were lower in FSH and LH in sirolimus- treated recipients than in non-sirolimus-treated controls, although the two groups showed no significant difference in serum prolactin levels in another study (21, 26, 27). Several studies show post-KT recipients’ improvement in the IIEF score (28-30). The impact of KT on ED is con- troversial. Many studies show successful KT may play an essential role in ED improvement (23), (22), which aligns with the current study's findings. In our study, ED was reported in 42 % of patients after KT compared to 92 % in patients on regular HD/PD. Sexual desire and orgasm were significantly better in post-KT patients. Furthermore, the mean total IIEF-15 score was signifi- cantly higher in the post-KT group (p < .001). Nevertheless, other studies have suggested that ED may persist in 20%-50% of patients (31, 32). Alternatively, it may worsen in patients younger than 45 years post-KT but is unaffected in patients older than 45 years (33). The study has limitations due to its small sample size, single- center nature, and retrospective design with data recall bias. Future research could consider a prospective ran- domized trial. CONCLUSIONS Our study showed that kidney transplantation could improve erectile function and restore normal sex hor- mone levels in ESRD male patients with ED. We demon- strated a significantly higher serum testosterone level and lower levels of luteinizing hormone and prolactin after renal transplantation compared to regular HD/PD. REFERENCES 1. Anantharaman P, Schmidt RJ. 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Al Faifi, MD Surgery Department, Section of Transplantation, Armed Forces Hospitals Southern Region Khamis Mushayte, 101, Saudi Arabia Omar Safar, MD Mahmoud Z. El Madawie, MD Saad Thamer, MD Muath Almurayyi, MD Urology Department, Armed Forces Hospitals Southern Region, Khamis Mushayte, 101, Saudi Arabia Osama Shalkamy, MD Urology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt Urology Department, Armed Forces Hospitals Southern Region, Khamis Mushayte, 101, Saudi Arabia Abdullah Mohammed Alqarni, MD Sami Saleh Amri, MD Ali Abdullah Hawan, MD Laboratory Department, Armed Forces Hospitals Southern Region, Khamis Mushayte, 101, Saudi Arabia Adel Elatreisy, MD Urology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt Urology Department, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia Conflict of interest: The authors declare no potential conflict of interest.