The impact of cognitive impairment in urologic implants: a narrative review

Introduction

Within the field of genitourinary surgery, three main implantable (and interactive) devices have been popularized with excellent short- and long-term outcomes: the penile prosthesis for erectile dysfunction (ED), the artificial urinary sphincter (AUS) for stress urinary incontinence (SUI, primarily in males) and implanted devices for sacral neuromodulation (SNM) for refractory overactive bladder (OAB), urinary urgency incontinence and non-obstructive urinary retention (1-11). While these implants have important, quality-of-life improving applications, they also have potential adverse events including device malfunction, infection, injury to adjacent anatomic structures that may necessitate removal of the device with or without re-implantation of a new device and repair of the injury (3,5,8,10-12). Thus, after a urologic device is implanted, it is important that patients are counseled on the long-term risks of the implant, have an understanding of how to use the device appropriately, and are instructed to continually monitor their devices for issues that could warrant re-intervention.

As ED and urinary incontinence are increasingly present in those with advanced age (13-20), the typical urologic patient receiving one of the aforementioned implants is older. With the older adult population projected to reach 21% of the total American population by 2030 (21) more people will be at risk for multiple issues associated with aging including cognitive impairment and dementia, both at time of implant and over the commonly lengthy device lifespan. The Diagnostics and Statistical Manual of Mental Disorders Fifth Edition uses the term ‘Neurocognitive Disorders’ to describe acquired deficits in cognitive function, which can be described as major type or mild type (22,23). Mild neurocognitive disorder, also known as mild cognitive impairment (MCI), is associated with modest decline in one or more cognitive domain (complex attention, executive function, learning and memory, language, perceptual-motor, or social cognition) without interference of a person’s independence in daily activities, whereas major neurocognitive disorder is synonymous with dementia and is characterized by the cognitive decline that impairs independence in everyday activities (22,23). While the prevalence of MCI is difficult to estimate, it has been reported between 3–42% in adults over 65 years old, with up to 15% advancing to dementia each year (24-29). Indeed, population estimates of people with MCI in the United States reaches over 16 million by 2030 and over 21.5 million by 2060.

Several studies have reported the association of frailty—a measure of physiologic vulnerability that manifests as increased susceptibility to adverse events such as falls, disability, loss of independence, and death (30,31)—with outcomes in urologic surgery. While frailty has been associated with increased risk of complication in urologic surgery (30,31), there have been reports specifically related to penile prostheses and SNM that showed no association of poor outcomes in frail older adults who undergo these surgeries (32-34). However, data assessing urologic implants in the setting of neurocognitive disorders are lacking. In this narrative review, we aim to report what is known about cognitive impairment (MCI and dementia) in association with penile prostheses, AUS and SNM; we will report data that has been published in this area and describe what urologists can do in counseling patients preoperatively and monitoring them postoperatively. We present this article in accordance with the Narrative Review reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-23-226/rc).

Methods

This is a narrative review. PubMed was used to search for sources. Searches were performed between December 1, 2022 and June 16, 2023. Search terms used were: neurocognitive disorder, cognitive impairment, mild cognitive impairment, dementia, cognitive status, elderly, elderly male, older male, screening, Penile prosthesis, Inflatable penile prosthesis, artificial urinary sphincter, sacral neuromodulation and outcomes. Timeframe for included studies were between the years 1975 and 2023. Only English language studies were included. While peer-reviewed published manuscripts were prioritized, abstracts and textbook chapters that fit our search criteria (found on google.com) were included. Each author was independently involved in literature search. The primary author (DJB) reviewed all included articles. The search strategy summary can be found in Table 1.

Discussion

Penile prostheses

For the last 50 years, penile prosthesis has been a recommended treatment for those suffering from ED, especially if refractory to pharmacotherapy (35,36). Innovations in technology and surgical approach over this time have led to a variety of prosthetic options for surgeons and patients. These devices have been shown to provide high rates of patient satisfaction and device longevity for ED, and concomitant issues like Peyronie’s disease and ischemic priapism (1-3,37,38).

Several forms of penile prostheses exist on the market today, including a 2-piece inflatable penile prosthesis (IPP), 3-piece IPP and a malleable (non-inflatable) device. Most IPPs work through a simple hydraulic mechanism in which a fluid reservoir (implanted in the pelvis or abdomen) is connected to inflatable cylinders (implanted in the corpora cavernosum) by a tubing system. The inflation and deflation of the cylinders is controlled manually through a pump that is typically implanted in the scrotum. Factors that lend modern IPPs the high rates of patient satisfaction are discreteness of the hydraulic pump mechanisms, ease and rapidness of activation, and their increased resistance to mechanical wear and erosion.

Much work has been done to elucidate characteristics that could predict patient satisfaction with penile prosthetic devices. Not surprisingly, there is scant information available to aid related clinical decision making in patients with ED who also have MCI. The AUA guideline on ED does not mention this as a potential concern (36). ED and aging are positively associated (14). However, age has not been shown to be a predictor of poor penile prosthetic outcomes. Chung et al. compared IPP outcomes between men under and over 75 years old and found similar IPP mechanical survival and patient satisfaction (39). Further, Villarreal et al. reported low infection rate and high satisfaction in a cohort of men over 71 years old (40). Still, in a study that assessed the relationship between sexual and cognitive function, Hsu et al. evaluated almost 1,000 men and found that decline in erectile function is associated with decline in cognitive function (13); interestingly, decline in sexual desire was not associated with decline in cognitive function (13). There is some data in regard to frailty—an estimation of patient physiologic vulnerability—and its association with penile prosthesis outcomes. Madbouly et al. found no association of frailty and IPP complications, whereas in a review of frailty assessment and penile prosthetics, Brennan et al. reported that frail patients had issues postoperatively with device manipulation (31,34).

Habot et al. recognized the importance of being aware that an older patient has a penile prosthesis in order to prevent prosthetic complications (41); the main concern they note is catheterization of these patients, especially if the caregiver has no knowledge of the presence of a penile prosthesis or how the implant works. Luna et al. reported a technique for permanent IPP deflation via puncture in 10 patients, 9 of which were requested due to the patient being diagnosed with dementia (42). They report a “typical case” of a man who was implanted over a decade prior who developed Alzheimer’s dementia and was unable to deflate the device; on assessment, he could not be retaught proper IPP use (42). A persistently inflated IPP can cause distress to the patient, relative or caretaker and even urethral erosion (42). Another consideration would be to exchange the IPP for a 1-piece malleable penile prosthesis. The benefit being that a patient with MCI who desires sexual activity could still enjoy the quality of life benefits from a penile prosthesis without the complexities of a 3-piece IPP. However, this would require an additional surgery (and its inherent complications) and may not alleviate the aforementioned catheterization issue. Further, there is no data reporting the role of malleable penile prosthesis placement in the setting of cognitive impairment.

An additional issue associated with cognitive impairment is inappropriate sexual behaviors or hypersexual behaviors (43-46). This sexual behavior is highlighted by disinhibited and indiscriminate behavior of a sexual nature that is out of the person’s control (46). The combination of inappropriate sexual behavior and presence of a penile prosthesis could potentially lead to inappropriate use of the device. To date, there have been no reports of this type of sexual behavior issue in association with penile implants. Still, permanent deactivation can alleviate these concerns and prevent complications associated with an IPP.

Mohan et al. reported survey results of how experienced prosthetic surgeons would approach several challenging clinical scenarios, including two patients with possible cognitive impairment—the first is a patient with Down Syndrome and the second is a non-verbal patient following a stroke (47). The authors report that providers are half as likely to offer an IPP to patients in these clinical scenarios as they would be to the baseline 50 years old male with medication-refractory ED (47). However, having a better understanding of the patient’s autonomy, including cognitive capacity to understand their surgery, resulted in higher odds of the provider offering IPP (47). The authors stress the importance of balancing the biomedical ethical principles (autonomy, nonmaleficence, beneficence and justice) during surgical planning (48); in the scenario of a patient with MCI, autonomy may be the key principle.

While there is no data specifically evaluating penile prosthesis outcomes in association with cognitive impairment, it is clear that prosthetic urologists need to consider this issue before and after implanting a penile prosthesis. Non-use of an IPP may have few risks, however, if an issue with the device were to arise, a urologist can consider removal of IPP (if patient is an acceptable surgical candidate) with or without malleable penile prosthesis placement (depending on the patient’s desire for sexual activity), or IPP deactivation via cylinder puncture, which can be safely performed in the clinic setting.

Artificial urinary sphincter

AUS is the primary treatment option for men with bothersome SUI (especially moderate to severe) after prostate surgery (18,49). In fact, the AUA/SUFU guideline on Incontinence after Prostate Treatment claims that AUS is the most predictable and reliable treatment of SUI after prostate treatment (49). Use of AUS in the treatment of male SUI has excellent long term outcomes (4-6,11); still, AUS have limited lifespans and will likely lose efficacy over time, possibly requiring re-operation (11,18,49).

An AUS device functions with 3 parts: an inflatable cuff that wraps around the urethra, a control pump located in the scrotum (or labia majora in women), and a pressure-regulating balloon in the lower abdomen or pelvis that provides constant occlusive pressure. The AUS is a hydraulic sphincter where the mechanical action of the device depends on the pump to inflate or deflate the cuff (50). When the device is active, the cuff is filled with fluid at baseline, compressing the urethra and preventing the passage of urine. To empty the urinary bladder, one squeezes the pump, moving fluid to the pressure-regulating balloon and allowing urine to pass out the urethra; the fluid soon passes from the pressure-regulating balloon back to the cuff to resume urethral compression and restore urinary continence. Thus, requirements to operate an AUS are manual dexterity to locate and then squeeze the pump and sufficient cognition to remember to compress the pump when preparing to urinate (51). If a patient does not have appropriate cognition to remember to cycle the device, a chronically active device can lead to urinary retention and complications thereof as well as urethral atrophy or injury.

Prior data has shown that incontinence after prostatectomy increases with age (16). Even though risk of MCI also increases with age, Chung et al. compared AUS outcomes between men under and over 70 years old and found similar clinical efficacy (52). Further, they found that frailty was not associated with higher AUS revision rate (52). Conversely, Ziegelmann et al. reported that men over 80 years old who have an AUS implanted have a higher risk of device infection or erosion compared to men under 60 years old with an AUS and that age over 80 years was independently associated with increased risk for device infection/erosion (53); still, 5-year overall device survival was not significantly different between any age groups. Further, Medendorp et al. reported that frailty is a significant predictor of 30-day postoperative major complications after an AUS implantation and that frailty and age over 85 years was associated with increased odds of undergoing an AUS removal procedure (compared to an AUS implantation) (54).

Unlike the AUA guideline on ED, the AUA/SUFU guideline on Incontinence after Prostate Treatment states that clinicians should ensure that patients demonstrate cognitive ability for proper use of the device (49). While data are limited, there are several reports of the association of MCI and AUS use and outcomes. Notably, a grave complication of inability to use AUS pump or confusion with device may be postrenal acute kidney failure and even end-stage renal disease as a result of chronically activated cuff (55). Wolski et al. described performing preoperative psychological assessments of 16 men who desired AUS and disqualified two patients due to cognitive disorders; they propose that psychological assessment should be included when working up a patient for AUS (56).

Two groups have retrospectively assessed the role of cognitive function on AUS outcomes. Raup et al., in a retrospective analysis of 213 men who underwent AUS implantation, were the first to report a higher rate of AUS failure and worse incontinence in patients with preoperative cognitive dysfunction (57). Still, they found no association between advanced age and AUS failure. It is notable that only 5 of the patients included in this study had cognitive dysfunction. The authors conclude that providers should make an effort to identify cognitive dysfunction before and after AUS implantation and should exercise caution if a patient with declining cognitive function desires AUS implantation. Keles et al. reported results of 163 patients who underwent AUS implantation with the primary objective of evaluating the role of baseline education level and cognitive status (Mini-Mental Status Exam (MMSE) score) on AUS success and revision rates (58). In their cohort, 20.2% had MCI and 42.3% had moderate cognitive impairment. They found that those with intact cognition and MCI had greater success (measured by continence rates) than those with moderate cognitive impairment. Neither education level nor age had an association with higher rate of failure or revision. These studies further highlight the importance of proper patient selection and counseling.

Limited study is available to inform prevalence of cognitive impairment and its impact on efficacy and outcomes longitudinally following implantation of an AUS. Ballantyne et al. took a different route in their study and assessed cognition using a telephone survey in 74 men who had previously undergone AUS implantation (59). Eighteen (24%) patients met criteria for cognitive impairment. Patients with impaired cognition had more difficulty using their device but no differences were seen in AUS revision, erosion or failure rates or incontinence rates between patients with normal and impaired cognition (59). The authors conclude that urologists should continually monitor AUS patients who may be affected by cognitive dysfunction. Indeed, O’Connor et al. and Léon et al., in their studies of the long-term outcomes of AUS implantation, reported device deactivation due to patient dementia (11,60), thus highlighting the importance of long term follow up and even cognitive assessment in men who have previously undergone AUS implantation.

Based on the limited data available, cognitive impairment is associated with poorer AUS outcomes. While the AUA/SUFU guideline on Incontinence after Prostate Treatment recommends clinicians ensure patients have adequate physical and cognitive abilities to operate an AUS (49), there is no standardized protocol for testing these abilities preoperatively or following these patients for the lifespan of the device. Identifying patients who may be at highest risk of developing cognitive decline or dementia is important for preoperative counseling (51). Further, if concerns about cognitive impairment or a patient’s ability to properly use the AUS arise post-AUS implantation, urologists should consider device deactivation. While this would render the patient incontinent again, deactivating the device will alleviate most concerns regarding device misuse, including urinary retention, urethral atrophy and device erosion, and likely decrease risks of severe complications.

Sacral neuromodulation

SNM therapy is Food and Drug Administration (FDA) approved for urinary urgency incontinence and non-obstructive urinary retention and also indicated for refractory OAB (17,61). Therapy involves delivery of continuous low-level stimulation to the S3 nerve root, which contains afferent sensory nerves from the pelvic floor and parasympathetic fibers to the bladder. Therapy is thought to modulate afferent signaling and thereby modulate both voiding and continence reflexes (62,63).

Currently available SNM devices include Medtronic Interstim^® and Axonics^®, both of which are implanted systems that include a permanent quadripolar tined lead and an implantable pulse generator (battery). Prior to implantation, patients must undergo a test-phase, in which either temporary wires (peripheral nerve evaluation) or the tined lead (Stage 1) are placed and connected to a temporary external battery for one-to-two-week timeframe. The test-phase is typically considered successful if the patient objectively demonstrates a 50% or greater improvement in symptoms compared to baseline, after which the permanent battery is placed. After placement, patients can control the device with a communicator, including turning therapy on/off, adjusting amplitude, and (for Medtronic^® devices) choosing amongst different programs.

Sacral neuromodulation therapy thus requires engagement with therapy during both the test-phase and following treatment. The AUA/SUFU guideline on overactive bladder indicates that a certain cognitive ability is needed to participate in and maintain any OAB therapy, although the guideline does not provide guidance regarding appropriate cognitive thresholds (17). As a technologic device, SNM theoretically may require higher cognitive thresholds compared to other OAB therapies such as pharmacotherapy or chemodenervation (32). Indeed patient interaction is often necessary to optimize device function and ensure patients are satisfied with the device program settings that they are using. Normal cognitive function along with an understanding of the device function are thus key aspects to a good outcome.

Understanding the effect of cognitive impairment on SNM treatment outcomes is particularly important in the OAB population because patients with cognitive impairment are more likely to suffer from OAB symptoms and have worse urinary incontinence compared to the general population (19,20,64). However, data are sparse on the subject. Furthermore, there are likewise no studies to our knowledge of the impact of cognitive impairment on other neuromodulation therapies for other disease states such as chronic pain, gastroparesis, or headache from which to extrapolate insight.

Zillioux et al., in a retrospective analysis of patients who underwent SNM for OAB found 10.2% (52/510) had cognitive impairment diagnosis in their chart at time of test-phase implant, with an additional 6% (30/510) receiving a diagnosis following test-phase SNM (65). Based on the retrospective methods which relied on electronic medical record diagnosis codes, the authors noted that these estimates were likely an underestimate. Multivariable analysis found that cognitive impairment diagnosis did not significantly impact rates of permanent implantation. Interestingly, on subanalysis, age was an independent negative predictor of permanent implantation. Device explantation and revision rates also did not differ based on presence of a cognitive impairment diagnosis. The authors conclude that a diagnosis of cognitive impairment should not necessarily exclude patients with refractory OAB from SNM therapy.

Conversely, interim analysis of an ongoing prospective study by Shenhar et al. of cognitive impairment in older patients (age over 60 years) undergoing test-phase SNM for OAB at the same institution found 67% (39/58) of patients met criteria for MCI at baseline (66). The authors report that in a short-term follow-up (mean 4.1 months), patients with cognitive impairment were less involved in changing programs or amplitudes but patient-reported outcomes did not differ (66). Study accrual is still ongoing and when complete should inform whether cognitive impairment impairs short-term SNM outcomes.

Taken together, very limited available data suggest SNM is efficacious in the short-term in patients with MCI. Further study is certainly needed to understand the efficacy, long-term durability and risks associated with SNM in this vulnerable population. It should be noted that SNM non-use is unlikely to cause severe complications. Still, for patients with or at risk for cognitive impairment, urologists should counsel on potential worse outcomes as optimizing device parameters may be more difficult without appropriate patient feedback.

Screening for cognitive impairment

This narrative review has thus far described the potential role of neurocognitive disorders in the outcomes of interactive urologic implants. It is notable that while MCI may advance to major neurocognitive disorder (dementia) over time, not all people with MCI progress to dementia. Studies have shown that 10–40% of people with MCI may return to normal cognition over 4 to 5 years (27,67,68). Indeed, it would benefit a urologist to have familiarity with longitudinally assessing patients for cognitive impairment, especially when a complex device has been implanted. Further, counseling these patients (and their partners and caregivers) on the risks of device misuse or malfunction related to development or progression of neurocognitive disorder is extremely important.

The United States Preventive Services Task Force (USPSTF) in 2020 concluded that evidence is lacking, and the balance of benefits and harms of screening for cognitive impairment cannot be determined (26). The screening tools that have been validated show a range of sensitivity and specificity for the detection of cognitive impairment. Screening tools are more sensitive and specific for dementia than MCI, and the effect often depends upon the prevalence of cognitive impairment within the community; for example, when the prevalence of dementia is high in people over 85 years, the positive predictive value of screening can be greater than 50%, however in a population of people 65–74 years old, where the prevalence is lower, the positive predictive value drops closer to 20% (26). It is important to note that the USPSTF recommendation applies to a general community-dwelling population of adults 65 years or older without recognized signs or symptoms of cognitive impairment. The American Academy of Neurology recommends that clinicians should assess for MCI in patients who have a self-concern or for whom a close contact voices a concern about memory or impaired cognition (29).

Screening tests typically include simple tasks to assess one or more domains of cognitive function. There are several screening tests available. The MMSE is a commonly used method for cognitive screening (69,70). Keles et al. used a Turkish version of the MMSE and Ballantyne et al. used a validated telephone MMSE (58,59). Other screening tests include clock drawing test (CDT, with several variations), Memory Alteration Test (M@T), Quick Screen for MCI, Addenbrook’s Cognitive Examination Revised (ACE-R), Consortium to Establish a Registry for Alzheimer’s Disease (CERAD), Saint Louis University Mental Status (SLUMS) Examination and Montreal Cognitive Assessment (MoCA) (71-80). Descriptive and statistical characteristics of each screening test can be found in Tables 2,3, respectively. Breton et al., performed a meta-analysis of almost 60 studies evaluating the outcomes of 7 different cognitive screening tests (72). A notable finding in their study, which can be useful to a urologist interested in screening for cognitive function, is that the quickest mean administration time reported is 5 minutes, for the CDT, M@T and the Quick Screen for MCI; MMSE at 10 minutes and MoCA at 10–12 minutes had the next lowest administration times. Tariq et al., in one of the first studies evaluating SLUMS, reported the mean administration time of 7 minutes (76). Regarding cognitive screening test accuracy, Pinto et al. performed a meta-analysis of 80 studies comparing MoCA to MMSE and found that MoCA was superior to MMSE in discriminating between individuals with MCI and normal cognition and similar in accuracy in detecting dementia (73). Breton et al. reported sensitivities and specificities for MCI diagnosis: M@T had 95.1% sensitivity and 84% specificity; ACE-R has 82.4% sensitivity and 77.7% specificity; CERAD had 82.4% sensitivity and 76% specificity; MoCA had 81.2% sensitivity and 74% specificity; Quick Screen for MCI had 77% sensitivity and 78.9% specificity; and MMSE had 66.4% sensitivity and 73.5% specificity (72). The authors note that the studies that evaluated the CDT found heterogeneous results, so sensitivities and specificities could not be quantified. However, Park et al. reported a meta-analysis of several variations of the CDT (77); CDT-Sunderland had 72.6% sensitivity and 87.9% specificity, CDT-Shulman had 82% sensitivity and 75.7% specificity and CDT-Rouleau had 60.5% sensitivity and 80.1% specificity (77). Tariq et al. reported sensitivity and specificity of SLUMS for MCI with different groupings based on level of education: for those with less than a high school education, SLUMS had 92% sensitivity and 81% specificity; for those with high school education or higher, SLUMS had a 95% sensitivity and 76% specificity (76). While these results are encouraging, Spencer et al., in a systematic review of SLUMS reported slightly lower sensitivities and specificities (81). Further, it is important to note that there are no meta-analyses published regarding studies that have evaluated SLUMS since the data is less robust. Thus, three screening tests, M@T, Quick Screen for MCI and SLUMS can be administered in a timely manner with useful accuracy (72,76).

While screening tests can adequately detect cognitive impairment, these tests are typically not intended to diagnose MCI or dementia. Instead, a positive screening test leads to additional, more formal assessments to confirm the diagnosis of a neurocognitive disorder and determine its subtypes (29,71). Further, there is concern about what interventions can be done to prevent progression of impaired cognition and if these interventions are beneficial (71). However, early identification of cognitive impairment, even subjective impairment, can help prosthetic urologists in terms of anticipating postoperative issues or complications with the aforementioned implants. If a urologist understands a patient’s type or severity of cognitive impairment, they can set up processes preoperatively to ensure patient compliance and may recommend closer surveillance postoperatively to limit complications and device misuse.

Lavi et al., in a review of physical and cognitive decline in aging men who desire AUS implantation, describe an algorithm that can be used to address a patient’s risk for future cognitive decline before implanting an AUS (51). They propose first assessing and counseling regarding a patient’s fitness (i.e., his physical health and comorbidities) followed by a hand grip test to assess for manual dexterity. Once these have been measured, a urologist should use gait speed to predict future cognitive impairment (51,82); if abnormal, then a urologist should use one of the aforementioned cognitive impairment screening tests and should counsel the patient about the increased risks of implantation. We have created an algorithm that may prove useful for urologists who place the aforementioned implants (Figure 1). While neither our nor Lavi et al.’s algorithms have been studied, they can be used as reasonable starting points to consider prior to implantation of any urologic device in patients with or at risk for cognitive impairment.

Figure 1 Algorithm for screening patients who desire urologic implant for cognitive impairment. ^†, Concern for impaired cognition as assessed by urologist or as reported by patient, caretaker or family member. ^‡, See Tables 2,3 for some available screening tests for cognitive impairment. Test choice based on urologist familiarity and available time. Alternatively, urologist may recommend consultation with neurocognitive disorder specialist. ^§, Regular, longitudinal follow-up recommended. Protocol per urologist discretion. ^¶, Based on urologist discretion. Can consider assessment based on development of abnormal gait speed or concerns of newly developed symptoms of cognitive impairment. CI, cognitive impairment.

Conclusions

There are limited data available on the association of neurocognitive disorders and urologic implants. With the general population aging and thus more patients developing bothersome ED, SUI and OAB, there will likely be a higher demand for three common implants in urology, the penile prosthesis, AUS and SNM, in the older population. Along with aging, often comes MCI or dementia, which can complicate matters if such cognitively impaired patients have had a urologic device implanted. While AUS outcomes may be slightly worse in the setting of cognitive impairment, SNM is efficacious in this population in the short term. There are several tests that providers can quickly use to screen for cognitive impairment, including M@T, Quick Screen for MCI and SLUMS; this screening may allow for appropriate preoperative counseling and closer postoperative monitoring and thus, could prevent complications. Further studies are required to assess outcomes in these populations and to describe how to properly assess for cognitive impairment in a way that is both beneficial for the patient and convenient and efficient for a urologist. This research will be important to help inform guidelines regarding the most appropriate manner to manage and survey this vulnerable patient population.

Acknowledgments

Funding: None.

Footnote

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-23-226/rc

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-23-226/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-23-226/coif). RPS serves as an unpaid editorial board member of Translational Andrology and Urology from August 2022 to July 2024. JZ reports co-investigator on independent, investigator-initiated study grant, payments made to institution from Medtronic. DER receives payment for expert review from Ethicon. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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