Stesura Seveso Archivio Italiano di Urologia e Andrologia 2025; 97(1):13541 1 ORIGINAL PAPER INTRODUCTION Radical prostatectomy (RP) is the most common treatment option for men with localized prostate cancer worldwide, being related to excellent and reproducible cancer control rates. Although progress has been made in nerve sparing (NS) surgery, erectile dysfunction (ED) still remains a com- mon long-term complication after RP. To overcome this issue, Khoudary et al performed the first simultaneous placement of a penile prosthesis during open RP in 1997, aiming at an early return to sexual function without any impact on oncological outcomes and without significant adverse effects (1). We describe a case series of patients who underwent laparoscopic extraperitoneal RP combined with PPI (during 2013) to evaluate the impact of this treat- ment strategy on preserving the full dimensions of the penis and improving patients’ sexual Quality of life (QoL) (2). Aim of this study is to illustrate the ten years follow up of this case series which has no terms of comparison in the world. Oncological and functional results were analyzed. MATERIALS AND METHODS Ten patients underwent simultaneous penile prosthesis implantation (PPI) (with an AMS InhibiZone prosthesis) and laparoscopic RP in 2013. They were evaluated by means of urological visits, dedicated questionnaires inherent in QoL and sexual function, objective measure- ments before surgery, at discharge from the hospital, on postoperative days 21 to 28, each 3 months for the first year, and each year thereafter for 10 years. The main out- come measures were biochemical recurrence-free rate, penile length, and quality of life.1 All procedures were performed according our standard practice. All patients and their partners underwent sexual counselling with a Introduction: Even today, despite technologi- cal evolution, erectile dysfunction remains the most feared complication after radical prostatectomy sur- gery expecially for patients who report pre-existent refractory erectile dysfunction (ED) and patients in whom there is a high risk of extracapsular disease, such as any cT2c or cT3, who undergo non-nerve sparing radical prostatectomy (RP). To overcome this issue, Khoudary et al. performed the first simultaneous placement of a penile prosthesis during open RP in 1997, aiming at an early return to sexual function without any impact on oncological outcomes and without significant adverse effects. Ten years ago we performed laparoscopic extraperi- toneal RP and simultaneous penile prosthesis implantation (PPI) on ten patients in order to preserve the full length of the penis and to improve their satisfaction and quality of life (QoL) increasing the chances of ED resolution. Objectives: Aim of this study is to illustrate the ten years follow up of this case series which has no terms of comparison in the world. Oncological and functional results were analyzed. Materials and Methods: In 2013 10 patients underwent simulta- neous PPI (with an AMS InhibiZone prosthesis). Patients were evaluated by means of urological visits, questionnaires, and objective measurements before surgery, at discharge from the hospital, on postoperative days 21 to 28, each 3 months for the first year, and each year thereafter. The main outcome meas- ures were biochemical recurrence-free rate, penile length and quality of life. Results: Eight patients with mean age 71 (range 66-75) were reached at the 10-year follow-up; one patient died of acute infarction 10 years after surgery and another one died of dis- ease 7 years after surgery. Partners had, currently, mean age 60 (range 37-71). Mean preoperative PSA was 9.3 (6.3-13.7) and mean PSA at 10 years was 0.08 (range 0.01-1.2). International index erectile function IIEF before surgery was 11 (range 9-14) and 23 (range 22-25) at 10 years. Partner sat- isfaction rating increased from 7 (post-surgical) to 8 at 10 years. Penis length was unchanged after 10 years: mean intra- operative length was 9 cm (range 8.5-9.5) and mean length at 10 years was 8.8 cm (range 8-9.5). Conclusions: In our cases, laparoscopic radical prostatectomy with the simultaneous implant of a penile prosthesis demon- strate to be an interesting option to offer to selected and highly motivated patients. Outcomes like preservation of the penis length, resuming of normal sexual activity 21 days after sur- gery, partner satisfaction and oncological safety at 10-year fol- Laparoscopic radical prostatectomy with the simultaneous implant of a penile prosthesis: Ten years follow up Nicola Mondaini 1, Andrea Abramo 1, Caterina Romeo 2, Fabio Crocerossa 1, Francesco Cantiello 1, Rocco Damiano 1, Riccardo Bartoletti 3 1 Department of Urology, Magna Graecia University, Catanzaro, Italy; 2 Department of Experimental Medicine, Magna Graecia University, Catanzaro, Italy; 3 Department of Urology, University of Pisa, Italy. DOI: 10.4081/aiua.2025.13541 Summary low-up make it a valid surgical technique to be proposed in clinical practice if performed by an experienced team in pros- thetic surgery. KEY WORDS: Radical Prostatectomy; Erectile dysfunction; Penile prosthesis; Andrology; Quality of life. Submitted 28 December 2024; Accepted 3 January 2025 Archivio Italiano di Urologia e Andrologia 2025; 97(1):13541 N. Mondaini, A. Abramo, C. Romeo, et al. 2 clinical sexologist, both before surgery, in order to assess their motivation to undergo such a procedure, and after surgery, in order to investigate their level of satisfaction with the results. The study was conducted in line with the STROBE statement (http://www.strobe-statement.org). Due to the retrospective nature of the study in Italy, it did not require approval by the local ethics committee. Nevertheless, it was conducted in line with the Good Clinical Practice guidelines and the ethical principles laid down in the latest version of the Declaration of Helsinki. Data collection All patients were evaluated with penile measurements and questionnaires which were administered before sur- gery, at discharge from the hospital, on postoperative days 21 to 28, each 3 months for the first year, and each 6 months thereafter. At the time of surgery, the following parameters were recorded: the patient’s and partner’s age, the Charlson comorbidity index, preoperative prostate- specific antigen levels, Gleason score, penile length, clin- ical prostate cancer stage (through an abdominal comput- ed tomography (CT) scan and skeletal scintigraphy), esti- mated blood loss, visual analogue scale (VAS) pain scores, analgesic use, duration of hospital stay, and surgical com- plications, according to the Clavien-Dindo classification. Penile length measurements Penile length was evaluated through a manual measure- ment of the fully stretched penis in the flaccid state. The length was obtained from the pubis to the tip of the penis and made in centimeters (3). Questionnaires Patients completed dedicated questionnaires for satisfac- tion and the 36-Item Short Form Health Survey (SF-36) questionnaire. Patients’ satisfaction was evaluated using patient-reported outcomes (PROs). QoL was measured using an Italian version of the SF-36 Health Survey, a test partic- ularly suitable for chronic conditions. A year after surgery patients and their partners were also asked to rate their level of sexual satisfaction on a scale of 1 to 10, with 1 meaning “completely unsatisfactory” and 10 meaning “maxi- mum level of satisfaction”. We decided to use the PROs tool instead of the International Index of Erectile Function questionnaire because the aim of the present study was to evaluate the impact of laparoscopic extraperitoneal RP with simultaneous PPI on patients’ satisfaction (1). Surgical procedure All laparoscopic RP procedures were performed by a single experienced uro-oncological surgeon (RB). All penile pros- theses were placed by a single surgeon with high-volume experience in PPI surgery (NM). Upon conclusion of the prostatectomy and after removing the prostate via access through a Hasson trocar we manually positioned the reser- voir. The pneumo-Retzius was redetermined and the posi- tioning of the reservoir optimized between the bladder and pubis. We then made a penile-scrotal incision and isolated the internal inguinal ring with a blunt incision as far as the external fascia of the rectal-abdominal muscles that was crossed by fine-tip forceps, the path of which was simulta- neously monitored from the laparoscopic access. The reser- voir tube, previously plugged with a special titanium plug, was then dislocated to the penile-scrotal incision. The reservoir was then inflated and its location checked once again. A pelvic drain was positioned and removed on day 1. After ensuring haemostasis, the implant was positioned. The two cylinders were initially positioned following bilat- eral cavernosotomy, followed by the pump that was placed at the level of the scrotum, and subsequently tubing were connected. The prosthesis was then almost fully activated for the first 24 hours with a compressive bandage. All patients stayed for 4 hours in a nurse-operated recovery room. The drain was removed on day 1 and patients were discharged from the hospital on day 4. On day 10, retro- grade and voiding cystography was carried out after removing the bladder catheter. Activation of the prostheses took place between day 21 and day 28. Ethical considerations The present study was conducted as a consecutive case series in which patients who received a similar treatment were followed and all outcomes were recorded and ana- lyzed. Even though the case series had a descriptive study design, the local ethical committee was informed about the study. RESULTS Among patients that were enrolled in this study with a median age of 71 years, one died of acute infarction 10 years after surgery (group no adjuvant therapy) and anoth- er died of disease 7 years after surgery (group radiotherapy after surgery). According to the Clavien-Dindo classifica- tion, the first patient reported a severe complication: migra- tion of the reservoir into the bladder, which was resolved without prosthesis removal. This occurred even though the reservoir had been placed under vision. A CT scan was car- ried out, and it demonstrated a lesion on the superior wall of the bladder due to a pressure ulcer formed by the reser- voir near a bladder diverticulum. The reservoir was then removed from the bladder and changed through laparo- tomic access. The bladder wall was then repaired and a catheter was placed. 2 After 7 days, the catheter was removed and the patient was discharged after cystography. No prosthesis infections occurred (Table 1). Table 1. Post-surgery penile lenght measurements. Time Median penile lenght (cm) Intraoperative 9.0 (8.5-9.5) 12 mo 9.0 (8-9.7) 24 mo 9.0 (8.2-9.7) 36 mo 9 (8-9.5) 48 mo 9 (8-9.5) 60 mo 9 (8-9.5) 72 mo 9 (8-9.5) 84 mo 9 (8-9.5) 96 mo 9 (8-9.5) 108 mo 8.8 (8-9.5) 120 mo 8.8 (8-9.5) Values are presented as median (range). Mo: months. Archivio Italiano di Urologia e Andrologia 2025; 97(1):13541 3 Radical prostatectomy with penile prosthesis implant Oncological outcomes Over a median follow-up of 120 months 3 patients were disease-free without adjuvant therapy, and 4 were on hormonal therapy; 1 of the latter group had to undergo radiotherapy after surgery. Penile length at the time of surgery and at the follow-up visits The median penile length at the time of the surgery was 9 cm. Post-surgery penile length measurements showed the preservation of the full dimensions of the penis compared to the preoperative measurements. No statistically signifi- cant differences were found between the preoperative penile length measurements and the follow-up measure- ments. However, a reduction of 0.5 cm was observed in only 20% of the patients, although no patients described having problems with their penile dimensions (Table 2). Quality of life evaluation The pre-surgery SF-36 median value was 97 (range, 96- 98). According to post-surgical sexual counselling with a clinical sexologist, all patients were satisfied with their penile implants, and the couples’ level of sexual satisfaction was rated a median of 8 (range, 7-10) at follow-up 1. The median post-surgery SF-36 score was 99 (range, 97- 99). A statistically significant difference was found between the pre-surgery and post-surgery SF-36 scores (p = 0.02) (Table 3). DISCUSSION In the 1990s, Clough et al. suggested the integration of plastic surgery techniques with breast-conserving treat- ments for breast cancer. In the urological setting, in 1997 Khoudary et al performed a combination procedure of open non-nerve-sparing retropubic RP and PPI in 50 men. This group was compared with a group of 72 men who went RP alone during the same time interval. No sig- nificant differences were noted in the preoperative patient variables. The mean operative time for prosthesis inser- tion was 82 minutes, and the mean time to sexual inter- course was 12.7 weeks. No prosthesis infections occurred, with a mean follow-up of 1.7 years. Four men (8%) required revision of their inflatable penile prosthe- sis. There were no significant differences between the combination procedure and RP alone with regard to esti- mated blood loss, length of hospital stay or analgesic use. Men who chose the simultaneous placement of a penile prosthesis with RP reported greater overall QoL (1). In the present paper we reported the results of simulta- neous PPI and RP performed from June 2013 to June 2014 in 10 patients who completed the study follow-up period (median, 32.2 months).” No difference was found between the time of surgery and the 2-year follow-up evaluation in terms of penile length. The pre-surgery 36- Item Short Form Health Survey (SF-36) median score was 97 The and median postoperative SF-36 score was 99 at 3 months follow-up (2). Patients were satisfied with their penile implants, and couples’ level of sexual satisfaction was rated median 8. Post-surgery penile lenght measure- ments showed the preservation of the full dimensions of the penis compared to the preoperative measurements. No prosthesis infections occurred, over a median follow- up of 120 months. In light of these results, laparoscopic extraperitoneal RP with simultaneous PPI could be pro- posed to selected and very motivated patients because: a) medicated AMS InhibiZone [American Medical Systems, Inc. (AMS), Minnetonka, MN, USA] penile prostheses reduce the risk of prosthesis infections. Moreover, the extraperitoneal approach is preferable in order to keep the prosthesis reservoir located in a place with a low risk of infection (3); b) simultaneous PPI preserves penile length; c) com- bined procedure reduces the duration of hospitaliza- tion and allows patients to quickly resume sexual activity. A faster return to a satisfactory sexual life could have a positive impact on QoL and on the cou- ple’s well-being (4). Some aspects of this study should be considered, in par- ticular the fact that all surgical oncological procedures were performed by a single dedicated surgeon and all prosthesis implantations were performed by the same surgeon with a high-volume experience. Moreover, the psychological counselling support and the involvement of the partner in the surgical decision-making process should be considered strengths of this study. The main limitation of this study is the fact that it was a consecutive case series. However, our findings could serve as a basis for planning future studies. The majority of our patients had low- or intermediate-risk cancers and they could have undergone complete nerve-sparing resection, which in experienced hands, does not result in high positive margin rates. However, all patients reported stable ED with no benefits from PDE5i or intracavernous therapy. For this reason, we did not consider this treatment strat- egy to be overtreatment. Finally, the inclusion of a psy- Table 2. Clinical, laboratory and demographic characteristics. Characteristic Value Patients 10 (2 died) Age (y) (at 120 mo) 71 (66-75) PSA (pre-surgery) 9.3 (6.3-13.7) PSA (post surgery) (at 120 mo) 0.08 (0.01-1.2) IIEF score (pre-surgery) 11 (9-14) IIEF score (post-surgery) (at 120 mo) 23 (22-25) Partner’s age (y) (at 120 mo) 60 (37-71) Values are presented as number only or median (range). PSA: prostate-specific antigen; IIEF: International Index of Erectile Function. Table 3. Questionnaire and quality of life results at enrolment and at last follow-up. Variable Quality of life result SF-36 Pre-surgery (enrolment) 97 (96-98) Post-surgery (120 m) 99 (97-99) Sexual satisfaction scale 8 (7-10) Values are presented as median (range). SF-36: 36-Item Short Form Health Survey. Archivio Italiano di Urologia e Andrologia 2025; 97(1):13541 N. Mondaini, A. Abramo, C. Romeo, et al. 4 chologist in the patients’ care should be considered a strength of this study. Psychological support during the PPI is a key means of improving adherence to the follow- up and overall outcomes. We believe that laparoscopic extraperitoneal RP can be considered an optimal surgical technique that offers con- siderable safety margins for the simultaneous implanta- tion of a tricomponent penile prosthesis, even though simultaneously performing 2 surgical procedures may increase the risk of complications. The hospitalization length is no longer than that required for normal surgery, and the additional costs of the prostheses can be easily amortized by avoiding the costs of a second surgical oper- ation for the penile implant and avoiding the postopera- tive use of prostaglandins for penile erection. The main complications of prostate cancer surgery are ED and urinary incontinence. Several patients received an artificial sphincter for urinary incontinence. The presence of a penile implant is not a contraindication for artificial sphincter implantation. The cuff can be placed through the perineal approach in the bulbar urethra or over the bladder neck in particular cases. The reservoir can be placed on the opposite site of the penile implant reservoir and the pump in the opposite part of the scrotum. CONCLUSIONS The aim of this study is to evaluate the outcome of simul- taneous PPI and RP. The ideal candidates are those who report pre-existent refractory ED and patients in whom there is a high risk of extracapsular disease, such as any cT2c or cT3, who undergo non-nerve sparing RP. A simultaneous procedure would avoid two admissions, reduce hospitalization time and guarantee a faster recov- ery of sexual function, preventing the otherwise unavoid- able loss of penile length. Since the urologist does not need to preserve the neurovascular bundles, as the penile implant will take care of postoperative rigidity, RP can be performed more radically from an oncological point of view, thus reducing the risk of recurrence and metastasis, especially in patients with high risk disease. In conclu- sion, simultaneous PPI with RP provides early sexual rehabilitation, improving patients' QoL, without compro- mising surgical outcomes. However, larger series will be necessary, to better identify the patients who are more likely to benefit from nerve sparing surgery and postop- erative penile rehabilitation from those who would are more likely to develop refractory ED post RP and would therefore benefit from simultaneous PPI. REFERENCES 1. Khoudary KP, DeWolf WC, Bruning CO 3rd, Morgentaler A. Immediate sexual rehabilitation by simultaneous placement of penile prosthesis in patients undergoing radical prostatectomy: initial results in 50 patients. Urology. 1997; 50:395-9. 2. Mondaini N, Cai T, Sarti E, et al. A Case Series of Patients Who Underwent Laparoscopic Extraperitoneal Radical Prostatectomy with the Simultaneous Implant of a Penile Prosthesis: Focus on Penile Length Preservation. World J Mens Health. 2018; 36:132-138. 3. Cakir OO, Pozzi E, Castiglione F, et al. Penile Length Measurement: Methodological Challenges and Recommendations, a Systematic Review. J Sex Med. 2020; 18:433-439. 4. Cocci A, Cito G, Romano A, et al. Radical prostatectomy and simultaneous penile prosthesis implantation: a narrative review. Int J Impot Res. 2020; 32:274-280. Correspondence Nicola Mondaini, MD (Corresponding Author) n.mondaini@unicz.it Andrea Abramo, MD a.abramo10@gmail.com Fabio Crocerossa, MD crocerossa@unicz.it Francesco Cantiello, MD cantiello@unicz.it Rocco Damiano, MD damiano@unicz.it Department of Urology, Magna Graecia University, 88100 Catanzaro Italy. Caterina Romeo, MD cateromeo93@hotmail.it Department of Experimental Medicine, Magna Graecia University, Catanzaro, Italy Riccardo Bartoletti, MD bartoletti@unipi.it Department of Urology, University of Pisa, Italy DECLARATIONS Ethical approval: The case series has been approved by the local medical research ethics committee. Protocol number 78901. Availability of data and material: The datasets used and/or analyzed during the current study are available upon reason- able request from the corresponding author. Competing interests: The authors declare that they have no competing interests. Funding: There are no sources of funding for the research. Authors' contributions: NM, study concept, data analysis and interpretation, manuscript original drafting; statistical analyses; AA, statistical analyses, contribution to manuscript writing and editing; CR, participated in writing FC, participat- ed in writing, language editing; FC, participated in writing, language editing; RD, critically reviewed the study proposal; RB, proofreading. All the authors read and approved the final version of the manuscript and agreed to be accountable for all aspects of the work. Acknowledgments: Not applicable.