Stesura Seveso Archivio Italiano di Urologia e Andrologia 2021; 93, 4404 ORIGINAL PAPER No conflict of interest declared. complications, both impairing patients’ quality of life (1). ED is classically attributed to the injury of neurovascular bundles. The persistent penile hypoxia due to the loss of physiological erections may lead the cavernous fibrosis and, ultimately, a decline in erectile function (2). The use of vasoactive drugs may improve tissue oxygena- tion through increased penile blood flow, and prevent penile fibrosis (3, 4). Therefore, early treatment with erec- togenic drugs may play an important role in sexual reha- bilitation after RP. Several treatments have been proposed to manage post- RP ED: intracavernous alprostadil injections (IAI), phospho- diesterase-5 (PDE-5) inhibitors and vacuum devices (4, 5). The IAI has become increasingly common, espe- cially after Montorsi et al. (6) reported that early postoper- ative administration of alprostadil injections significantly increased the recovery rate of spontaneous erections after RP. The IAI is a complex procedure. It involves the prepa- ration of the syringe, identification of the injection site and correct administration, which requires a minimum of dexterity. Moreover, the need of a penile injection and the loss of spontaneity of the sexual act may lead to patient anxiety. Most studies reported high discontinuation rates of patients treated with IAI, and the lack of explanation and lack of follow-up were important causes of treatment failure and non-compliance (7). So, it is crucial to clearly inform patients and partners about the objectives of the treatment and expectations of sexual recovery. Due to the time required to explain the IAI procedure to the patient during medical consultations and sexual counselling dur- ing the follow-up, the management of post-RP ED is chal- lenging. Therefore, some studies reported an erectile rehabilitation program provided by a urology specialist nurse with good results (8). In this study we evaluated a sexual rehabilitation program (SRP) for patients with ED after RP, assessing the rate of compliance and reasons for dropout. MATERIALS AND METHODS The present study is a single-center, retrospective study. The SRP with IAI was offered to all patients who under- went non-nerve sparing radical prostatectomy from 1 January 2010 to 31 December 2019. A preoperative eval- Introduction and objectives: Erectile dysfunc- tion (ED) is a common complication after radical prostatectomy that affects quality of life. There are sev- eral therapeutic options, including intracavernous alprostadil injections (IAI). However, no specific recommendations have been made on the optimal rehabilitation strategy. In this study we evaluated a sexual rehabilitation program (SRP) with IAI for patients with ED after radical prostatectomy, assessing the rate of compliance and reasons for dropout. Methods: The sexual rehabilitation program (SRP) was offered to all patients who underwent radical prostatectomy from 1 January 2010 to 31 December 2019. The first consultations were performed by a urology specialist nurse, explaining the IAI procedure and possible complications. The program was consid- ered successful when the patients achieved autonomy in the drug preparation with a good injection technique. A medical consulta- tion was performed at 6 months evaluating the IAI usage and adverse events. In case of dropout, a questionnaire about rea- sons for dropout was performed. The primary endpoint was the rate of compliance and dropout of the program. Secondary end- points were the reasons for dropout and adverse events. Results: 340 patients underwent radical prostatectomy at our institution, and 123 patients accepted to participate in the reha- bilitation program. A total of 96 patients (78%) successfully completed the SRP, and at 6 months 60 (62.5%) still used IAI. Concerning the reasons for dropping out, the most frequent were the need of injectable therapy and pain. Regarding compli- cations, 17 patients (13.8%) reported pain related to the injec- tion and 1 patient (0.8%) had a priapism, managed with conser- vative treatment. Conclusions: Management of post-radical prostatectomy ED by a nursing program achieved good rates of patients’ self-injection accomplishment and treatment compliance. Close monitoring for dose adjustment and management of post-injection penile pain is required during the follow-up. KEY WORDS: Radical prostatectomy; Erectile dysfunction; Sexual rehabilitation; Alprostadil. Submitted 11 August 2021; Accepted 14 October 2021 INTRODUTION Radical prostatectomy (RP) is a therapeutic option for patients with localized prostate cancer. Erectile dysfunction (ED) and urinary incontinence are the most common Sexual rehabilitation with intracavernous alprostadil after radical prostatectomy: Outcomes from a nursing program Alexandre Gromicho 1, Pedro Costa 2, Débora Araújo 2, Daniela Pereira 2, Luís Ferraz 2 1 Urology Department, Centro Hospitalar do Funchal, Portugal; 2 Urology Department, Centro Hospitalar Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia, Portugal. DOI: 10.4081/aiua.2021.4.404 Summary 405Archivio Italiano di Urologia e Andrologia 2021; 93, 4 Alprostadil after radical prostatectomy uation included a detailed medical history and sexual habits, assessing the quality of erection, libido, orgasm and ejaculation. The therapy was offered at the first post-operative con- sultation and initiated once the patient was interested in sexual rehabilitation, usually after proper continence con- trol. A consultation was performed by a urology special- ist nurse and the sexual partner was asked to participate as well. The first consultation evaluated the changes in the sexual habits and expectations with the treatment. The process of preparation and administration IAI, as well as the possible complications associated, were explained. Then the patients were seen once a week and information was collected about the previous administration (efficacy, side effects), the injection technique and the correct dose adjustment if necessary. The quality of erections was eval- uated through the Erection Hardness Score (EHS). The program was considered successful when the patients achieved autonomy in the drug preparation with a good injection technique. In case of dropout, a questionnaire about reasons for dropout was performed. A medical con- sultation was performed at 6 months after completing the program, evaluating the IAI usage and adverse events. Reasons for abandoning the IAI at 6 months were also reported. The primary endpoint was the rate of compliance and dropout of the program. Secondary endpoints were the reasons for dropout and adverse events. Data were analysed using SPSS. RESULTS A total of 340 patients underwent radical prostatectomy at our institution, and 123 patients (36.2%) accepted to participate in the rehabilitation program. Population demographic and clinical features are show in Table 1. The median (IQR) age of the cohort was 63 (60-67) years old. The median time (IQR) between the surgery and the rehabilitation program was 6.8 (3.6-11.2) months. All patients reported being sexually active before the surgery, with 118 (95.6%) without preoperative erectile dysfunc- tion symptoms. 36.6% of the patients were initially treat- ed with PDE-5 inhibitors, without success. The first con- sultations were performed with the patient and sexual partner in 72 cases (58.5%). The alprostadil dose distri- bution is represented on Table 2 and 111 patients (90.2%) achieved erection hard enough for sexual inter- course after IAI (EHS 3 or 4). In general, a minimum of 3 (± 0.7) nursing consultations were performed before patients successfully completed the program. A total of 27 patients (22%) dropped out over the first consultations and did not complete the rehabilitation program. Of the 96 patients who completed the initial rehabilitation pro- gram, 60 (62.5%) still used intracavernous alprostadil at 6 months. The reasons for dropping out are described on Table 3. In most cases was the need of injectable therapy. The second most frequent reason was injection pain, despite adjusting to the lowest effective dose. Regarding complications, 17 patients (13.8%) reported pain related to the injection and 1 patient (0.8%) had a priapism, managed with conservative treatment. There was no significant difference in drop-out rates with age, diabetes mellitus, previous radiotherapy, previous PDE-5 inhibitors, time between surgery-rehabilitation program and urinary incontinence (p > 0.05). DISCUSSION Radical prostatectomy is one of the most frequent thera- peutic options used for the management of patients diag- nosed with localized prostate cancer. However, this treat- ment has a negative effect on patients’ quality of life, par- ticularly affecting sexual life. In fact, some studies con- cluded that sexual dysfunction was an independent deter- minant of worse general health-related quality of life after primary treatment for prostate cancer (9). Most of the studies published in the literature evaluates the effective- ness of drugs used in erectile function recovery, but few data are available concerning the protocols and drug compliance. Intracavernous alprostadil remains the main treatment for erectile rehabilitation after radical prostate- ctomy, improving sexual function also in patients treated with non-nerve sparing technique (10). The beginning of IAI and patient follow-up can become problematic due to the overload of medical consultations. For these reasons Table 1. Population characteristics. Characteristics (n = 123) Statistic Age (years), median (IQR) 63 (60-67) Pre-operative erectile dysfunction symptoms, n (%) 4 Diabetes mellitus, n (%) 13 Previous radiotherapy, n (%) 14.6 Previous PDE-5 inhibitors, n (%) 36.6 Time between surgery and rehabilitation program (months), median (IQR) 6.8 (3.6-11.2) Urinary incontinence, n (%) • No 60.2 • Mild 32.5 • Moderate to severe 6.5 PDE-5: phosphodiesterase-5. Table 2. Alprostadil dose distribution. Alprostadil lowest effective dose (ug) N (%) 5 10 (8.4) 10 60 (50.4) 15 2 (1.7) 20 47 (39.5) Table 3. Reason for dropping out the rehabilitation program. N (%) Injectable therapy 22 (37.3) Injection pain 12 (20.3) Loss of follow up 8 (13.6) Lack of sexual interest 7 (11.9) Urinary incontinence 3 (5.1) Lack of treatment efficacy 2 (3.4) Archivio Italiano di Urologia e Andrologia 2021; 93, 4 A. Gromicho, P. Costa, D. Araújo, D. Pereira, L. Ferraz 406 our department created a program aimed at sexual reha- bilitation, provided with the help of urology specialist nurses. In our study, 78% (n = 96) of the patients who agreed to participate successfully completed SRP. They were able to successfully self-administer the IAI and achieved the abil- ity to adjust the correct doses. In 58.5% the nursing con- sultations were performed with the couple, highlighting the role of spouses/partner in the sexual rehabilitation. The revaluation at 6 months after the program concluded that 60 patients (62.5%) still used IAI. Regarding the rea- sons for dropping out, the most frequent were the need of injectable therapy (patients with fear of needles and patients who refuse to undergo injectable therapy) and pain. Interestingly, the cost of the drug was never stated as a reason for dropping out. Regarding patients who abandoned therapy at 6 months, it should be noted that 4 patients (12.9%) were able to achieve erection without IAI. Therefore, despite being a potentially effective treat- ment, the fact that it is an injectable treatment was a major limitation for these patients. Pain was reported in only 17 patients (13.8%), especially in the first consulta- tions, but was a major reason for dropping out in only 9 patients. The cause of post-IAI pain is not well known and its management is challenging. Patients were recom- mended to take analgesics 1 hour before the injection and reduce to the lowest effective dose, but in some cases that was not satisfactory. Other strategies reported in the liter- ature were combining the IAI with a numbing product or the use a mixture of vasoactive drugs such as Trimix (combination of alprostadil, phentolamine and papaver- ine) (11, 12). The combination allows lower doses of each drug, reduc- ing the adverse events. However, none of these combina- tion drugs have a clinical authorization in the treatment of erectile dysfunction and are not available in Portugal. The dropout rate at the end of the program and at 6 months were 22% and 37.5%, respectively. For standard rehabilitation with intracavernous alprostadil, drop-out rates of 41-68% have been reported, most occurring dur- ing the first three months (1). So, our results demonstrate lower discontinuation rates than those reported for stan- dard rehabilitation therapy, but comparable with other studies of IAI in which nursing and sexual counselling was performed and maintained (8, 13, 14). Also post-IAI pain rate was lower than in other studies. Taken together, these results may indicate that a SRP was a key factor for increasing the motivation of the couples and treatment compliance, as well for minimizing the adverse events. Although not being a primary outcome, the efficacy of IAI was also evaluated. After the first consultation, 90% of the patients achieved erections hard enough for sexual inter- course. Our results are comparable with other studies, which reported success rates ranged from 70% to 95% (3, 9, 13). Similarly, the percentage of patients without pre- operative erectile dysfunction was quite high for a popu- lation with a median age of 63 years old. A possible expla- nation is the fact that younger patients with no preopera- tive symptoms of erectile dysfunction were the most motivated to initiate sexual rehabilitation. Also, the erec- tile dysfunction symptoms were not evaluated through validated questionnaires and the final results may not be accurate. Regarding the time between the surgery and the rehabili- tation program, it was approximately 7 months. The rea- sons for the delay were not reported, but it could be due to the necessity of adjuvant radiotherapy, hormonal ther- apy or transient urinary incontinence, discouraging some patients from undertaking SRP. On the other hand, patient’s anxiety concerning the oncologic outcomes is usual in the first medical consultations, having a negative impact on the motivation to initiate SRP. 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Luís de Camões 57, 9000-177, Funchal (Portugal) Pedro Costa, MD pedro_r_costa@hotmail.com Débora Araújo, MD deboracerqueiraaraujo@gmail.com Daniela Pereira, MD filipa.pereira27@gmail.com Luís Ferraz, MD ferrasluis@gmail.com Urology Department, Centro Hospitalar Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia (Portugal)