Effect of hormonal therapy on satisfaction rates after penile prosthesis surgery in prostate cancer survivors

Abstract

Background: Prostate cancer, a prevalent malignancy in men, often results in erectile dysfunction (ED), particularly following treatments like radical prostatectomy (RP) and radiotherapy, significantly affecting quality of life. Managing ED in prostate cancer survivors is critical. Inflatable penile prosthesis (IPP) implantation is a well-established treatment for ED, yet the literature on satisfaction rates for patients with a history of androgen deprivation therapy (ADT) remains sparse. We aimed to investigate the impact of ADT on satisfaction rates in patients undergoing IPP implantation following RP or radiation therapy (XRT).

Methods: A retrospective review of 529 patient charts identified 96 eligible patients who underwent IPP implantation post-prostate cancer treatment and completed the 11-item Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. Patients were stratified into two groups based on ADT status, and their satisfaction scores were compared. Effect sizes were used to assess clinical relevance alongside statistical significance (p = 0.0344).

Results: Patients receiving ADT had significantly lower EDITS scores (p = 0.0344) compared to those not on ADT. RP patients reported higher satisfaction post-IPP compared to XRT patients, even after controlling for ADT. Additionally, coronary artery disease (CAD) was associated with lower satisfaction scores.

Conclusion: ADT significantly lowers patient satisfaction post-IPP, with RP patients generally reporting higher satisfaction than XRT patients. These findings highlight the importance of counseling prostate cancer patients on ADT's impact on long-term sexual satisfaction and suggest areas for further research to enhance outcomes.

Graphical abstract

Keywords

androgen deprivation therapy / erectile dysfunction / men's health / penile prosthesis / prostate cancer / sexual satisfaction

1 INTRODUCTION

Prostate cancer, the most common malignancy in men, often has a slow-growing course and significant incidence and mortality rates[1]. Over 160 000 new cases are diagnosed annually in the United States, with risk factors including age, family history, and obesity. Treatment options range from active surveillance, radical prostatectomy (RP), and radiotherapy (XRT), to hormone therapy and chemotherapy for advanced stages[2,3]. These treatments can impact quality of life, notably causing erectile dysfunction (ED) and urinary incontinence, particularly after prostatectomy and radiotherapy[4]. Sexual function, in particular, significantly affects overall quality of life and patient satisfaction, with psychological distress and depression being prevalent in the first year post-diagnosis[5]. The American Cancer Society highlights that androgen deprivation therapy (ADT) is associated with a threefold increased risk of ED, a five- to six-fold increased risk of reduced libido, and persistent sexual dysfunction, underscoring the critical role of testosterone in sexual function[6]. These effects are not only physical but also psychological, affecting the emotional and relational intimacy of patients and their partners[6,7]. The complex interplay of physical dysfunction and psychological distress necessitates a multidisciplinary approach, involving urologists, oncologists, mental health professionals, and sex therapists, to comprehensively address these challenges. A multidisciplinary approach can provide tailored interventions that improve both sexual function and the overall quality of life for cancer survivors and their partners.

The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) is a widely used and reliable questionnaire in the field, designed to assess treatment satisfaction for both patients and their partners[8]. Additionally, creating separate versions for patients and their partners helps capture both perspectives, providing a fuller understanding of the treatment's impact.

The literature on satisfaction rates for patients who have undergone inflatable penile prosthesis (IPP) implantation for ED and have a history of ADT for prostate cancer is notably sparse[9]. While many studies evaluate satisfaction rates post-IPP implantation in general populations and specific subgroups, there is a distinct gap in research addressing patients with a history of ADT[10]. ADT significantly affects sexual function, potentially influencing satisfaction outcomes post-IPP implantation, yet studies rarely stratify for the effects of ADT. The American Society of Clinical Oncology (ASCO) guidelines do not provide specific data on satisfaction rates post-IPP in patients with prior ADT, highlighting a critical gap in the literature[10]. Addressing this gap is essential for better clinical decision-making and patient counseling in this specific patient population.

2 MATERIALS AND METHODS

2.1 Study design

A retrospective chart review from our IRB-approved institutional database was conducted to identify 529 patients who underwent IPP by a single surgeon at our institution from 2017 to 2022. Eligible patients for inclusion included those with histological confirmation of prostate cancer treated by RP or XRT with or without hormonal therapy, followed by IPP implantation for ED, and had completed the 11-item EDITS validated questionnaire with data available for review. All EDITS questionnaires were administered at least 6 months from operative date or later. All patients were impotent at the time of IPP surgery. Exclusion criteria included patients who had prostate cancer that was not treated with either RP or XRT, patients who had not completed the EDITS questionnaire, and patients who did not have IPP implantation for ED. See Figure 1 for visualization of the study inclusion and exclusion criteria.

Eligible patients were screened for placement into one of two groups depending on their ADT status. Patients in the XRT and RP groups exclusively received their respective treatments, meaning those in the XRT group never underwent RP, and those in the RP group never received XRT. To prevent crossover confounding, patients with history of other types of hormonal therapy for non-prostate cancer patients were excluded. Final data was obtained from 31 patients in the XRT group and 65 patients in the RP group. Out of the 31 patients who received a XRT, 17 received ADT. Out of the 65 patients who received a RP, 13 received ADT. A patient selection flowchart for inclusion is included in Figure 1. Among the 65 patients who underwent RP, 13 received neoadjuvant ADT due to suspected extracapsular extension as indicated by MRI, high-grade tumor (Gleason 8 or above), or extensive tumor burden on biopsy.

2.2 Data collection

Patient charts were reviewed for patient demographics including age, self-reported ethnicity, body mass index (BMI), comorbidities, pre-operative penile Doppler results. Surgical information including surgical approach, reservoir location, etiology of ED were retrieved. Additionally, various comorbidities were reviewed in the chart. Comorbidity data was obtained on a subset of the total number of patients that met the inclusion and exclusion criteria (n = 88) for coronary artery disease (CAD) (n = 39), hypertension (n = 40), and diabetes (n = 40). Implants used were the AMS 700 LGX/CX/CXR (Boston Scientific) and the Titan (Coloplast).

2.3 EDITS score

The EDITS score is a validated tool used to assess treatment satisfaction in patients with ED. The EDITS questionnaire consists of 11 items, each rated on a scale from 0 to 4, with higher scores indicating greater satisfaction. A clinically important difference (CID) on the EDITS score is approximately 10 points, which helps in interpreting the clinical relevance of treatment outcomes. This tool is particularly useful in clinical trials and practices to gauge patient satisfaction with various ED treatments, including those undergoing ADT[11].

Mean EDITS scores were calculated for the total cohort and stratified by group. Mean responses to the 11-item EDITS questionnaire were compared between the two groups as a measurement of device and sexual satisfaction. Responses ranged from 0 to 4, with 4 indicating higher levels of satisfaction relevant to each specific question. EDITS scores were compared between different groups to test for statistical significance.

2.4 Statistical analysis

For statistical analysis, the mean responses to EDITS and additional questions were compared between groups using the independent t-test. p < 0.05 was considered statistically significant. Python 3.10 was used for statistical analysis using the Scipy and Seaborn libraries.

3 RESULTS

A total of 96 patients were included after meeting the inclusion criteria, with 32.3% (n = 31) in the XRT-only group and 67.7% (n = 65) in the RP group. Demographics, hormone therapy, device information, EDITS score, and penile Doppler data are reported in Table 1, both for total cohort and stratified by group. The total sample of 96 patients was categorized into group 1 (ADT, n = 30) and group 2 (No ADT, n = 66). Of the XRT-only group, 45.2% (n = 14) did not have ADT and 54.8% (n = 17) underwent ADT. Of the RP group, 80% (n = 52) did not have ADT and 20% (n = 13) underwent ADT.

The study revealed notable results regarding the impact of ADT on post IPP satisfaction rates in which group 1 exhibited a significantly lower EDITS score compared to group 2 (p = 0.0344) (Figure 2). Furthermore, group 1 showed no significant changes in post IPP satisfaction with relation to the type of prostate cancer treatment offered (Figure 3), while group 2 demonstrated a significantly higher EDITS score post IPP in RP patients compared to XRT (Figure 3), which aligns with the reported literature. It is important to note that prostate cancer treatment modality had a noticeable pattern with EDITS score whereby patients treated with RP had significantly higher EDITS scores than those treated with XRT exclusively (Figure 3). It is important to note that the duration of ADT treatment was not accounted for in the results and no distinctions were made to stratify patients based on the amount of time patients received ADT.

Additionally, there was a significant difference found in the subset of patients who had CAD, with patients without CAD having significantly higher EDITS scores than those patients with CAD (Figure 4). Furthermore, when comparing prostate cancer treatment modalities with only patient samples present in the study who were confirmed to not have CAD (n = 34), patients who received RP had significantly higher EDITS scores than those patients who received XRT (Figure 5). The sample of patients who had CAD (n = 5) were all under the XRT category, which suggests that prostate cancer therapy modality could be a confounding factor in this result.

4 DISCUSSION

The novelty in this study lies in exploring the effects of ADT in conjunction with the type of prostate cancer therapy received on IPP satisfaction rates as a form of ED treatment. The main finding of the study is that patients who received ADT had statistically significantly lower post-IPP satisfaction EDITS scores than patients who did not receive ADT therapy. Before even considering the modality of initial prostate cancer therapy of XRT versus RP, it can be clinically reasoned that treating prostate cancer with either therapy followed by ADT will contribute to worsened ED symptoms than in those patients who did not receive ADT. This presentation has been well-defined in previous works and is an expected result[12]. Similar work has been done in the past investigating the relationship between ED and ADT in the study by DiBlasio et. al., which found patients younger than 70 and without diabetes had associations with ED after ADT[13]. Our study addresses a limitation by including a control group of patients who did not receive ADT, contrasting with DiBlasio et al.'s approach that relied on self-reported ED diagnoses, which often results in under-reporting and skews findings. Unlike their study, we utilized the EDITS score to quantify the severity of ED more accurately. However, DiBlasio et al.'s research had the advantage of a more comprehensive data set that incorporated comorbidity data, allowing for analyses with confounders such as diabetes, a known factor influencing ED and patient satisfaction with IPP[13]. One potential explanation for the lower EDITS scores observed in patients undergoing ADT is the impact of hormonal therapy on penile tissue, which can lead to penile atrophy and reduced size. The suppression of testosterone, a key hormone targeted by ADT, not only affects prostate cancer cells but also has significant effects on penile tissue health. This hormonal reduction can diminish tissue elasticity and overall penile functionality, contributing to the decreased sexual satisfaction scores reported in these patients[14,15]. Another key finding was that patients who did not receive hormone therapy had statistically significantly higher EDITS scores for those who received radical prostatectomies compared to those who received radiation therapy for their prostate cancer (Figure 3). This finding was consistent with the findings in the study by Shen et al. which concluded that 44% of all older patients were diagnosed with ED within 5 years of prostate cancer treatment[16]. Patients treated with RP had double the rate of ED when compared to patients treated with XRT and were thus more likely to get IPP, which is in concordance with the observations in our study as there was a greater sample of RP patients who received IPP when compared to XRT patients who had an IPP procedure. The key point to draw from this finding is that patients who received RP had higher satisfaction with their IPP when compared to XRT patients. When analyzing why XRT patients had lower post IPP satisfaction, the study by Rogers et al. showed the rate of ED in XRT patients increased from 4% to 47% over a 5-year span due to irreversible and slow-progressing vascular damage[17]. This underlying pathophysiology helps explain why patients with XRT tend to have worse outcomes post-IPP therapy. The study by Potosky et al. found that there was an improvement in sexual function between 6 months and 2 years post-prostatectomy while there was a continuous decrease in function over time for patients treated with XRT[18]. When removing the extra independent variable of whether or not a patient received ADT therapy, the findings in our cohort were consistent with previous studies. There is an increased rate of ED in RP patients when compared to XRT patients. Thus, RP patients were more likely to get treated for ED than XRT patients. However, XRT patients who developed ED were more likely to have a continuous decline in function, which is in line with these patients having statistically significantly lower satisfaction scores with their IPP implants when compared to RP patients.

It was also found that patients who received RP had statistically significantly higher EDITS scores than patients who received XRT. This finding was not consistent with findings of other studies[19–22]. The study by Lane et al. out of England had a finding where significantly more men were being affected by ED after undergoing RP when compared to XRT[19]. A similar study conducted in Australia also discovered that post RP patients had especially worse long-term sexual outcomes[20]. A possible reason could be the usage of EDITS score in our study to quantify post-IPP satisfaction and the IPP procedure could have made a significantly greater impact for RP patients than it did for XRT patients. Furthermore, this result stayed consistent when controlling for patients who did not receive ADT as RP still had statistically significantly higher post-IPP EDITS scores than the post-IPP EDITS scores of XRT. When controlling for patients who did receive ADT, there was no statistically significant difference between patients who received XRT and RP. This could indicate that ADT therapy plays a bigger role in post-IPP satisfaction than either prostate cancer treatment methodology[21,22]. One argument against this finding is the smaller sample size of only 30 total patients in the study who received ADT and thus continuously adding samples to this study and applying the same methodology can help improve the strength of this finding.

Out of the data available on patients with CAD, it was found patients who had CAD had statistically significantly lower post-IPP EDITS scores than those patients who did not have CAD. This result aligns with recent findings[23]. Our results found there was a correlation between ED severity and coronary artery disease and heart failure. A study by Solomon et al. in 2003 concludes that linking CAD with ED symptoms is a common phenomenon and credits this to endothelial dysfunction being a common risk factor between the two disease processes[24]. The sample size of CAD patients in our study was small (n = 5), limiting the generalizability of our findings. Further investigation with a larger cohort and more comprehensive metadata is necessary to better understand the post-IPP outcomes in this patient population. Such studies could provide deeper insights into the specific impacts of CAD on recovery and satisfaction following IPP. Moreover, when controlling for patients without CAD, the patients who received RP for prostate cancer treatment had higher post-IPP EDITS scores than those patients who had XRT for prostate cancer treatment, further supporting findings from previous studies[23,24].

Key takeaways for clinical practice from this study include the need to raise awareness about the impact of ADT on post-treatment sexual satisfaction and to educate patients on potential drawbacks. Furthermore, the observation that patients undergoing RP report higher IPP satisfaction compared to those receiving radiation therapy (XRT) suggests that IPP interventions might be more effective for RP patients.

To enhance future research, it is advisable to increase the sample size for more robust data, enabling a comprehensive analysis that captures subtle differences in patient outcomes. Including testosterone level data is crucial due to its significant influence on ED treatment effectiveness and IPP satisfaction[25]. Detailed metadata on ADT regimens, diagnosis timelines, and comorbidities will enhance understanding of treatment impacts. Further, expanding data collection to include comprehensive comorbidity analysis and CAD status will fill existing data gaps. Employing longitudinal studies and standardized measurement tools like the EDITS score, alongside collaboration across multiple medical centers, will strengthen the generalizability of findings.

5 CONCLUSION

This study highlights that patients who received ADT are more likely to report lower EDITS satisfaction scores post-IPP surgery compared to those who did not undergo ADT. Additionally, patients treated with RP demonstrated higher satisfaction rates post-IPP than those treated with XRT. These findings underscore the need for routine pre-treatment counseling on the long-term effects of ADT, including its potential to diminish the effectiveness of ED treatments and reduce satisfaction with IPP outcomes.

Future research should focus on multicenter studies to validate these findings, explore strategies to mitigate ADT-related sexual dysfunction, and identify interventions that optimize satisfaction in this patient population.

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