bluuebunny/crossref_metadata_2025 huggingface dataset:
(070) Androgen Status in Men and Risk Of COVID-19 Complications: An Analysis of United States Claims Data
Authors: Dolendo I , Patel D , Horns J , Nguyen V , Hsieh T , Pastuszak A , Hotaling J
Published: February 2024

Introduction

Biological males have had worse COVID-19 outcomes compared to females. Yet, the impact of hypogonadism (HG) on COVID complications remains unclear.

Objective

We sought to compare COVID complications in males with various androgen status (eugonadal, treated HG, untreated HG) to females to evaluate the effect of testosterone levels on COVID outcomes.

Methods

We used the IBM MarketScan database of commercial claims encounters to identify patients ages 18+ with a COVID diagnosis (n=756,855). We compared eugonadal males (no HG diagnosis), untreated HG males (HG diagnosis without therapy), treated HG males (HG diagnosis and testosterone prescription within 180 days before COVID diagnosis) to females. Rates of intensive care unit (ICU) admission co-occurring with initial COVID diagnosis were modeled using logistic regression. Acute respiratory distress syndrome (ARDS), acute respiratory failure (ARF), and use of critical care services (CCS) were modeled using Cox proportional hazards models. Outcomes were regressed against group, age, rurality, and Charlson Comorbidity Index.

Results

Eugonadal males (n=315,050) were at higher odds of ICU admission (OR: 1.611, 95% CI: 1.549-1.676), having ARDS (HR 1.766, CI: 1.670-1.868), having ARF (HR 1.609, CI: 1.575-1.644), and needing CCS (HR 1.696, CI: 1.652-1.742) compared to females. Treated HG males (n=2,343) and untreated HG males (n=22,614) were also more likely to experience all adverse outcomes compared to females. For untreated HG males the effect was less pronounced compared to eugonadal males and treated HG males for all outcomes (Figure 1). There were no differences in odds of all outcomes for castrate males (n=89) compared to females due to small sample size.

Conclusions

Eugonadal males, treated HG males, and untreated HG males were more likely to have adverse COVID outcomes compared to females. This effect was most pronounced for eugonadal and treated HG males compared to untreated HG males, suggesting normal androgen status is detrimental to COVID-19 outcomes. This is one of the largest studies to show a complex relationship between testosterone and COVID outcomes.

Disclosure

No.
(085) Long-Term Outcomes of Testosterone Replacement Therapy Delaying Biochemical Recurrence Post-RARP: Frequency-Matched Case-Control Study
Authors: Hammad MAM , Tran J , Nguyen MX , Gevorkyan R , Fung C , Yafi FA , Huynh LM , Ahlering T
Published: February 2024

Introduction

Testosterone Replacement Therapy (TRT) is known to improve functional and sexual outcomes in hypogonadal men. TRT historically has been contraindicated for the management of hypogonadism in men with prostate cancer (PC).

Objective

In 2020, we demonstrated in a cohort of 850 men that TRT reduced biochemical recurrence (BCR) by 50% (median follow-up 3.5 yrs.). The present study extends the follow up to 5.25 years

Methods

A retrospective review of prospectively collected data between December 2009 and June 2018 undergoing robotic radical prostatectomy by a single surgeon was conducted. 152 patients were administered TRT post-RP with a calculated free testosterone (cFT; below the 25%) and were frequency matched to 420 patients not receiving TRT with respect to pathological stage (p-stage) and Gleason Grade Group (GGG). Biochemical recurrence (BCR) was defined as two consecutive prostate specific antigen (PSA) blood tests >0.2 ng/mL. An adjusted Kaplan-Meier (KM) graph was used to analyze rate and time to BCR.

Results

Baseline differences in demographics were observed in BMI (p = 0.006) and follow up time (p = 0.0023), and cFT (p = 0.0156). While overall BCR was not significantly different between the two groups, a difference was observed in time to recurrence. In adjusted KM analysis, patients with a higher calculated free testosterone were less likely to have a BCR (p = 0.05). In the same analysis, patients with a higher GGG, p-stage, and preoperative PSA (p <0.01) were more likely to have a BCR. Patients receiving TRT had similar rates of BCR (p = 0.676). However, if they recurred, there was an average delay of 1.4 years.

Conclusions

TRT was observed to have a continuing protective effect in preventing and delaying BCR in patients post-RARP when compared to patients who did not receive TRT.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.
(087) Testosterone Replacement Therapy in Men on Active Surveillance for Prostate Cancer: Using a Novel Database to Examine Disease Progression
Authors: Applewhite JP , Saffati G , Naeem T , Chaput MB , Patel S , Lipshultz LI , Khera M
Published: February 2024

Introduction

Traditionally, the use of testosterone replacement therapy (TRT) in hypogonadal men on active surveillance (AS) with prostate cancer (PC) has been controversial, and for many providers, contraindicated. However, studies suggesting a need to revisit the association between TRT and prostate cancer progression have contributed to a recent paradigm shift in this approach. More studies are needed to analyze this relationship, especially due to the psychosocial and biological consequences of testosterone deficiency.

Objective

We aim to examine the effects of TRT on PC progression in hypogonadal men on active surveillance.

Methods

In this retrospective chart review, data from men diagnosed with hypogonadism and PC at a single hospital system between 2009 to 2022 were compiled into a database. Inclusion criteria for this specific study included men who underwent TRT while being on AS protocol for PC. Men receiving prior treatment for PC such as prostatectomy or radiation therapy were excluded. For each patient, PSA and total testosterone (TT) levels were recorded at 12 and 6 months prior to TRT, at the onset of TRT, and 3, 6, and 12 months following TRT initiation. One-way ANOVA was used to analyze variance in mean PSA and TT. Mean TT levels pre-TRT and post-TRT were calculated and analyzed for a significant difference. Progression to PC treatment was noted for each patient.

Results

30 men meet the study criteria. The table below demonstrates the mean PSA and TT levels at each time interval. There was a significant variation in mean TT (P=0.0031) while there was no significant difference in mean PSA levels (P=0.3003) throughout the 2-year study period. Mean TT before initiation of TRT was 297.97 ng/dL, and mean TT after TRT was 716.15 ng/dL. There was an increase in mean TT after starting TRT (P=0.00072). One patient (3.3%) eventually underwent radiation therapy for PC five years after initiating TRT.

Conclusions

In hypogonadal men on AS for PC, no significant change in PSA level was observed after initiating TRT, despite an increase in testosterone. As we grow the database, we aim to increase the power of this study. Our findings contribute to the mounting evidence demonstrating TRT may be a viable option for hypogonadal men on AS.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Disclosures: Consultant for AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast Investor: Sprout.
(096) Use of GLP-1 Agonists Associated with Diagnosis of Hypogonadism in Large Retrospective Cohort
Authors: Crisostomo-Wynne T , Santamaria A , Holt S , Hehemann M
Published: February 2024

Introduction

Glucagon-like peptide receptor agonist (GLP-1a) medications are a novel treatment for type 2 diabetes mellitus (DM), receiving US FDA approval for this indication in 2017. The use of these medications is increasing rapidly for both diabetes and weight loss, and FDA approval was granted for treatment of obesity in 2021. There is evidence that these medications have a direct effect on the hypothalamic-pituitary-gonadal (HPG) axis in animal studies and mixed findings in small human studies. The effects on the HPG axis in humans with long-term use has not been described.

Objective

To determine if there is a correlation between use of GLP-1a medications and subsequent diagnosis of hypogonadism in men.

Methods

The Marketscan Research database was queried for men who received a prescription for any GLP-1a medication from 2017 to 2020. The length of time on the medication was then compared to subsequent diagnosis of hypogonadism for up to one year after initiation of treatment. Men with a preexisting diagnosis of hypogonadism were excluded.

Results

The initial query yielded 116,704 patients receiving a prescription for GLP-1a medication. Of these, 26,668 received the prescription for at least 1 year. Of those with prescription duration >1 year, 1,075 (4.0%) men had a new diagnosis of hypogonadism within the next year following GLP1a initiation. The mean age of men was similar between those with and without hypogonadism (50.33 vs 50.26, p = 0.8). Using point-biserial correlation, the length of time on the medication was compared with a new diagnosis of hypogonadism. There was a weak but significant correlation between the time on the medication and new diagnosis of hypogonadism (rpb = -0.015, p = 0.015)

Conclusions

This large cohort of patients shows a significant correlation between the length of time taking GLP-1a and the subsequent development of hypogonadism within one year of initiating treatment. Along with prior research, this study raises concerns about the use of GLP1a medication and possible long term effects its use.

Disclosure

No.
(141) Surgical Outcomes of Infrapubic Insertion of the Inflatable Penile Prosthesis in 175 Transmen After Phalloplasty
Authors: Chen M , Patel D , Hotaling J , Sun H , Gupta S , Hsieh T , Goodwin I , Watt A , Lin W , Safa B
Published: February 2024

Introduction

Historically, inflatable penile prostheses (IPP) insertion in a neophallus has an estimated 40-50% surgical revision rate.

Objective

To review the surgical outcomes of a single center’s experience with the infrapubic approach to insertion of the IPP after phalloplasty in transmen.

Methods

The infrapubic prosthesis insertion after phalloplasty (IPIP) technique involves a horizontal incision anterior to the pubic symphysis, which allows dissection of the neophallus channel, the Space of Retzius, and the scrotal pocket. Surgical outcomes using the Titan (Coloplast, Minneapolis, MN) IPP by a single surgeon (MLC) were analyzed between October 2017 and June 2023. Complications were reviewed and categorized into erosions, infections, device malposition and malfunction, and less common events like necrosis and urinary tract injury.

Results

The IPIP technique was performed on 175 phalloplasty patients by a single surgeon (MLC): 156 patients had a prior RF phalloplasty, and 19 had a prior ALT phalloplasty. The mean followup was 32.8 months. Surgical revision was required in 35 patients (20%). There were 10 pump erosions through the neoscrotum, 1 glans erosion, 9 infections, 6 pump malpositions in the neoscrotum, 6 cylinder malposition in the neophallus, 3 mechanical malfunctions with broken tubing, 2 urethral injuries, 2 bladder injuries, and 1 glans necrosis. There were no instances of implant detachment from the pubic bone anchor site, osteomyelitis, nor total phallus loss.

Conclusions

Data for the IPIP technique using the commercially available Coloplast Titan IPP suggest a reduction in neophallus prosthetic surgical revision rates compared to previous reports. Longer term studies with patient reported outcomes are required for further evaluation.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific.
(150) Erectile Dysfunction and Peyronie’s Disease Diagnosis Rates After Penile Fracture – A Retrospective Claims Database Cohort Analysis
Authors: Physicians M , Maremanda A , Kohn T , Able C , Burnett A
Published: February 2024

Introduction

Penile fracture (PF) is a rare urologic emergency, with an estimated incidence of 500-600 PFs per year in the United States. Delays in surgical repair increase the risk of developing erectile dysfunction (ED) and Peyronie’s disease (PD).

Objective

Our objective was to analyze the rates of ED and PD following a PF using a large, multi-institutional claims database.

Methods

We conducted a cohort analysis utilizing the TriNetX Research database. The inclusion criteria included men ages 15 or older with a diagnosis of PF and any office visit within 5 years of the PF. Our exclusion criteria included any prior ED diagnosis, prescription of erectile aids, or penile prosthesis placement. Our primary outcome was the diagnosis of ED or prescription of erectile-aid dosing of phosphodiesterase-5 inhibitors (PDE5i) within five years. A secondary analysis was used to assess rates of PD following a PF. Subgroup analyses were performed for age and the impact of initial repair. Propensity-matching was performed to compare men with and without PF by calculating risk ratios (RR).

Results

1,242 men were identified with a diagnosis of PF and subsequently matched to men without a PF, resulting in equal cohorts of 1,227 men. Men with a history of PF were more likely to receive a diagnosis of ED or require PDE5i (RR 3.18, 95% CI 2.30-4.40). Men over the age of 45 years who had a PF were more likely to develop ED or require ED treatment compared to men under 45 years (RR: 1.65, 95% CI 1.14-2.39). Men who did not undergo immediate repair had higher rates of ED diagnoses or treatment (RR: 1.84, 95% CI 1.22-2.78). Rates of PD diagnoses were significantly higher in men with a history of PF (5.8% vs 0%, p-value<0.0001). Rates of PD were significantly lower if immediate repair of the fracture was performed (RR: 0.20, 95% CI 0.10-0.41). Men over the age of 45 years with a history of a penile fracture were more likely to develop Peyronie’s Disease within 5 years compared to men under the age of 45 years with a history of penile fracture (RR: 3.73, 95% CI 1.94-7.16).

Conclusions

We found that a PF increases the risk of both ED and PD, especially for those treated with conservative measures or over the age of 45 years. Consequently, it is essential to follow up with these patients in the long term and survey potential adverse side effects relating to sexual function that may arise.

Disclosure

No.
(168) Downgrading Surgical Recommendations After Intralesional Injections of Collagenase Clostridium Histolyticum in Peyronie’s Disease Patients
Authors: Hata L , Horodyski L , Metro M
Published: February 2024

Introduction

After patients undergo intralesional injections of collagenase clostridium histolyticum (CCH) as a primary treatment for Peyronie’s disease (PD), they may have residual curvature and may opt for secondary treatment with surgery. On the other hand, the initial severity of curvature may be best addressed by plaque incision and grafting (PIG), but the surgeon may offer CCH with the intent that post-CCH curvature can be treated with a penile plication (PP) rather than a PIG.

Objective

Our study investigated the group of PD patients who had their surgical recommendations downgraded from a plaque incision and grafting (PIG) to penile plication (PP), a less complicated procedure, after receiving CCH.

Methods

Our retrospective, single institution chart review included patients from 2016 to 2022 who underwent surgery to treat PD. We then looked at patients who underwent CCH then PP, and compared those who were initially recommended PIG before CCH to those who were initially recommended PP. Functional penile length was also evaluated as the length of the erect penis, from the base of the pubis to the tip of the glans, in a straight line while disregarding any curvature.

Results

Our study included 53 men who underwent surgery for treatment of PD, with mean age 56.0 (SD 11.3) at presentation. Of the 24 patients who underwent CCH, their pre-CCH and post-CCH surgery recommendations were: PP then PP in 5 patients (21%), PIG then PP in 11 (46%), PIG then PIG in 8 (33%) (Figure 1). The PIG then PP recommended group had a pre-CCH primary curvature range of 30 to 64 degrees, and post-CCH range of 16 to 46 degrees (Table 1). These patients had no significant difference in operative duration, difficulty, functional penile length, or complications (Table 2). The PIG then PP recommended group had 5 patients (46%) who reported functional residual curves that were manage conservatively, which was not significantly different from the PP then PP recommended group (0 patients, 0%, p=0.08).

Conclusions

Intralesional injections of CCH helped to downgrade surgical recommendations from the more drastic PIG to the simpler PP in a subset of PD patients, without compromising operative difficulty or postoperative outcomes. This finding is encouraging given that PP can be performed in a shorter operative time, by less experienced surgeons, and with lower risk of postoperative sensation and erectile issues.

Disclosure

No.
(198) Gaps in Patient Representation for Peyronie’s Disease Clinical Trials
Authors: Leelani N , Shumaker A , Khooblall P , Bole R , Lundy SD , Bajic P
Published: February 2024

Introduction

Recent studies have highlighted the lack of generalizability of clinical trials with respect to patient race and ethnicity for urologic diseases due to inadequate recruitment and reporting of racial and ethnic minority populations in clinical trials. To date, there have been no studies examining the diversity of patients with Peyronie’s disease recruited to clinical trials.

Objective

The objective of this study was to identify disparities in representation of patients in PD clinical trials relating to race and ethnicity.

Methods

A systematic electronic search of the published English literature was performed to identify clinical trials involving PD. The search was performed using the Medline/Pubmed, Ovid, and Embase databases. After articles were identified, they were screened based on their title and abstract. Articles were included if they were in English, relevant to Peyronie’s disease and specified clinical trial in the title or abstract. Exclusion criteria were articles about congenital penile curvature, systematic reviews, pooled analysis, and articles not in the English language.

Results

Of the 48 articles included in the analysis, 10 of them reported race, ethnicity, or sexual orientation. All 10 studies reported enrollment of Caucasian men, with Caucasian men making up 98.0% of the enrolled population across these 10 studies. Enrollment of African-American men were was reported in six of the 10 studies and constituted 2.6% of the enrollees. Enrollment of Asian men were was reported in three studies and comprised of 0.7% of the patients in those studies. Enrollment of American Indian/Native American men were was reported in a single study and made up 0.2% of patients enrolled in that study. Hispanic ethnicity was the only ethnicity reported and was available in five studies with of 4.0% of men reported as Hispanic across those studies. Only two studies reported the sexual orientation of patients. Five of the 10 studies that reported race enrolled patients exclusively from the United States. A pooled analysis from these 5 studies revealed that Caucasian men were significantly overrepresented and all other racial and ethnic groups were significantly underrepresented (p < .05).

Conclusions

In conclusion there is a lack of representation of multiple racial and ethnic minorities with PD along with the over-representation of Caucasian men. Aside from the lack of reporting of racial and ethnic information, there was a dearth of information on sexual orientation of men in these clinical trials.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific.
(223) Using Aglan Flap in Peyronie`s Surgery
Authors: Aglan A
Published: February 2024

Introduction

Surgical therapy is indicated if: 1- Deviation compromises or makes sex practice impossible. 2- Conservative treatment has failed. 3- Disease duration is at least 12 months. 4- The stable phase is at least 6 months. When deviation is greater than 60 degrees many centers prefer a grafting procedure to avoid penile shortening, grafting procedures leads to potential lengthening of the concave side of the deviation. The resulting tunical defect may be filled using an auto graft .e.g. detubulerized saphenous vein, fascia-lata, buccal mucosa, allograft e.g human pericardial tissues and human fibrinogen and thrombin coated onto equine collagen sponge, or xenografts e.g bovine pericardial and bovine intestinal submucosal tissues. Currently there is no consensus on the most suitable graft material for penile graft, many surgeons used synthetic grafts e.g self-adhesive collagen fleece, we were used the elastic wall of silicone caps with penile implants as a cover to the defects during implantation with peyronie`s previously. Synthetic grafts has the risk of infection, sensory loss, altered glans sensation, recurrent curvature due to graft contraction and length loss. So synthetic grafts should be avoided. Penile plication is simple and minimally invasive but invariably may results in penile length loss and may in fact worsen the existing hour-glass or hinge effect.

Objective

Presentation of new method to cover defects in peyronie`s diseases.

Methods

Methods two patients were operated, excision of the plaque was done, dissection of caval tissues in subtunical plane, elevation of Aglan caval flap, penile implantation (maliable), covering of the implant by the flap and suturing, second layer of the nearby tissues was added. The dissection could be done up to 360 degrees.

Results

Follow up for six months was done, both patients have no complications initial decrease in sensation was reported, improved within 3 months completely, the flap is safe, very vascular could be based at any point. It is natural, economic with minimal side effects if compared with synthetic grafts. Obvious nerves at area of excision should be retracted away if possible for maintenance of sensation. It could be used to cover defects with peyronie`s or other tunical defects with implantation.

Conclusions

Aglan flap is safe, economic, simple and effective method for covering tunical defects in peyronie`s disease.

Disclosure

No.
(248) Evaluation of Androgen Receptor Signaling and Saturation in Erectile Dysfunction
Authors: Khodamoradi K , Campbell K , Codrington J , Varnum A , Arora H , Ramasamy R
Published: February 2024

Introduction

Testosterone (T) is a steroid hormone responsible for the development and maintenance of male secondary sex characteristics. T exerts this physiologic function throughout by binding to the androgen receptor (AR). It is unclear how AR function varies as a function of serum T.

Objective

We hypothesized that there is a saturation value for the AR above which excess serum T does not lead to increased binding or downstream signaling. This study evaluated whether varied serum T levels were associated with AR signaling in the penile tissue of men with erectile dysfunction (ED).

Methods

The mean age of participants was 61 (IQR 8.5) years. The mean serum T level was 300.2 (IQR 231.3). The results of the western blot showed that HO and PDE-5 signaling was decreased in men with serum T less than 200 ng/dL compared to those with serum T above 200, while AR and iNOS expression was decreased in men with serum T less than 300 ng/dL compared to those with serum T above 300.

Results

Within a wide range of serum T values, AR signaling was similar in penile tissue above 200-300 ng/dL. These findings provide a possible explanation for why PDE5 inhibitors are most effective in men with serum testosterone levels greater than 200 ng/dL, as our western blot results indicate that PDE-5 signaling is diminished in men with lower serum testosterone levels. This suggests that maintaining eugonadal levels of serum androgens is essential for optimal functioning of PDE-5 inhibitors.

Conclusions

Our findings suggest that there is a limit to the effect of serum testosterone levels on AR signaling, as the downstream activity appears to plateau beyond a certain point of receptor activation.

Disclosure

No.
(251) Exogenous Leptin Treatment Augments Testicular T-cell Secretion and Function Differentially in Context to BMI in Murine Models
Authors: Arora H , Khodamorad K
Published: February 2024

Introduction

In previous research, we explored the effects of exogenous Leptin treatment on modulating the immune landscape within the testicular microenvironment (TME). We found that within the TME, it is the CD8+ T cells which were enriched upon Leptin treatment. However, our earlier study did not took into account the impact of variations in BMI which could potentially confound the effects of Leptin on T cells and on TME as a whole.

Objective

To investigate the impact of Leptin on a complete testicular immune microenvironment.

Methods

We used 6-week-old C57BL6 mice (n=30), grouped into three, with first group subjected to regular diet, second to Lean fat and third to high fat inducing diet. Once the mice reached the desired weights, they were exposed to two different concentrations of Leptin, 10 and 100 mg/ml, for seven days. After the treatment period, the animals were humanely euthanized, and their blood and testes were collected. Blood samples underwent a CBC differential profile analysis using a Hemavet Mascot Multispecies Hematology System Counter 1500R. Testes samples were subjected to comprehensive immunophenotyping, allowing us to assess the impact of Leptin treatment on various immune cell types within the testes.

Results

In mice with regular BMI, Leptin at a low dose (10 mg/ml) showed increased, but not significant, levels of serum testosterone (13.20 + 0.37 ng/dl), while LH and FSH levels significantly (p<0.05) increased. In contrast, animals receiving 100 mg/ml Leptin showed no significant changes in hormone levels. CBC profiling indicated that lymphocytes and platelets were significantly influenced, specifically upon low doses of Leptin. Comprehensive immunophenotyping revealed a significant increase in CD4+ (helper T cells) and CD8+ (cytotoxic T lymphocytes) cell numbers in animals treated with low doses of Leptin, a pattern not observed with high doses. These results were in contrast to the mice which represented lean and obese conditions.

Conclusions

This study uncovers previously unexplored aspects of how exogenous Leptin treatments can modulate the immune microenvironment within the testis, potentially impacting testosterone production. Future research will investigate the relationship between changes in immune cell types, increased T cell numbers, and their influence on Leydig stem cell differentiation into adult Leydig cells.

Disclosure

No.
(258) Trends in Prevalence, Incidence and Pharmacological Prescriptions for Premature and Delayed Ejaculation – A Claims Database Analysis
Authors: Liao B , Banner S , Vodnala S , Able C , Vu K , Sonstein J , Alzweri L , Kohn T
Published: February 2024

Introduction

Premature (PE) and delayed (DE) ejaculation are common male sexual dysfunction disorders. Despite a community-reported prevalence of approximately 30% for PE and 5% for DE, the clinical prevalence, incidence, and rates of pharmacological prescriptions for both disorders remain under-investigated in the literature.

Objective

Our objective is to assess the trends in prevalence, incidence, and pharmacological treatment of PE and DE using a large claims database.

Methods

The TriNetX Research database, a large insurance claims database, was queried to identify all adult (≥18 years) males that were evaluated from January 2012 through December 2022. The number of men diagnosed with PE (ICD-10 F52.4) and DE (F52.32 and N53.11) was compared to the total number of men evaluated using six-month intervals (January-June, July-December) to calculate percent prevalence and incidence. A chi-squared test of linear trends was performed for prevalence and incidence. Rates of prescribed treatments were calculated comparing the number of men receiving the treatment to the total number of men with the assessed disorder using six-month intervals for PE and one-year intervals for DE.

Results

A total of 17,647 adult males with a diagnosis of PE and 6,304 adult males with a diagnosis of DE were identified from January 2012 to December 2022. The prevalence and incidence for both disorders are found in Figure 1. The chi-square test for trends showed a significant increasing trend in the prevalence of PE (χ2 = 303.44, p-value = <0.0001) and DE (χ2 = 314.14, p-value = <0.0001) and incidence of PE (χ2 = 6.40, p-value = 0.0114) and DE (χ2 = 187.43, p-value = <0.0001). In the final period, 63.5% males with PE and 33.4% males with DE received at least one medication of the investigated therapies. The most common medications prescribed to men with PE were phosphodiesterase-5 inhibitors (25.7%), paroxetine (17.4%), topical anesthetics (13.4%), and sertraline (12.2%). The most common medications prescribed to men with DE were testosterone (11.7%), bupropion (12.2%), and cabergoline (10.0%). The prescription rates of all of the investigated medications for PE and DE are shown in Figures 2 and 3, respectively.

Conclusions

In this large US claims database analysis, premature and delayed ejaculation are overall diagnosed at low but increasing rates. Furthermore, the rates of pharmacological prescriptions for PE remains relatively low, despite pharmacotherapy being recommended as first-line options under the current guidelines. Additional research is necessary to investigate the long-term efficacy of individual medications for both PE and DE.

Disclosure

No.
(267) The Prevalence of Conditions Involving Aberrant Mast Cell Activity in Patients with Neuroproliferative Vestibulodynia
Authors: Goldstein S , Goldstein I , Kim NN , Drian A , Dempsey T , Mueller J , Yee A
Published: February 2024

Introduction

Neuroproliferative vestibulodynia (NPV) is a provoked vestibular pain, shown to be associated with excess immunohistochemical staining for CD117 and PGP9.5, consistent with mast cells and nerves, respectively. It is hypothesized that NPV occurs in genetically predisposed patients in whom mast cells accumulate in the vestibular sub-epithelial stroma where they release various cytokines/growth factors that stimulate the growth of nerves, causing severe allodynia and hyperalgesia throughout the entire vestibule.

Objective

To assess, in our patient cohort with histopathologically confirmed diagnosis of NPV, the prevalence of concomitant conditions involving aberrant mast cell activity.

Methods

Medical records from people with vulvas who underwent vestibulectomy between June 1, 2019 and December 31, 2022 were retrospectively reviewed. This research protocol was IRB-exempt. Histories from these patients, all of whom had histopathologically confirmed NPV after observing > 8 immunopositive CD117 stained cells per high-power field in the sub-epithelial stroma, were reviewed. The prevalence was noted for the presence of concomitant conditions where aberrant mast cell activity has been reported to play a critical role in symptomatology. The focus was on the following eight conditions: asthma, chronic sinusitis, endometriosis, food allergy/intolerance, interstitial cystitis, irritable bowel syndrome, migraine, and postural orthostatic tachycardia syndrome.

Results

A total of 65 NPV patients were included in this chart review. While 24 (37%) reported none, 41 (63%) had at least one other concomitant condition involving aberrant mast cell activity. A total of 25 (38%), 10 (15%), 4 (6%) and 2 (3%) had one, two, three and five other conditions, respectively, involving aberrant mast cell activity. The most common such condition was migraine (n=14; 22%), followed by endometriosis (n=12; 19%), food allergy/intolerance (n=11; 17%), interstitial cystitis (n=10; 15%), irritable bowel syndrome (n=8; 12%), asthma (n=7; 11%), chronic sinusitis (n=5; 8%) and postural orthostatic tachycardia syndrome (n=2; 3%). There was no correlation between the number of concomitant conditions with aberrant mast cell activity reported and the density of CD117-immunopositive staining in the overall cohort of patients with NPV or within the subgroups of those with either lifelong or acquired NPV.

Conclusions

Patients with histopathologically confirmed NPV have a high prevalence of concomitant conditions associated with aberrant mast cell activity. While more studies are needed, NPV is likely part of a broader systemic collection of conditions associated with aberrant mast cell activity. This finding is relevant in terms of future diagnostic and treatment options for patients with NPV.

Disclosure

No.
(290) Impact of Neoadjuvant Relugolix on Patient-Reported Sexual Function and Bother
Authors: Gallagher L , Wells M , Hsueh J , Danner M , Zwart A , Ayoob M , Yung T , Simpson T , Kumar D , Leger P , Dawson N , Suy S , Rubin R , Collins S
Published: February 2024

Introduction

Relugolix is an oral GnRH receptor antagonist used in combination with radiation therapy in the treatment of unfavorable prostate cancer. It has been shown to achieve rapid and profound testosterone suppression (total testosterone <20 ng/dL) without the need for bothersome injections. Such low testosterone levels may impact sexual functioning and perceptions.

Objective

Given the potential benefits of Relugolix over other androgen deprivation therapies (ADTs), this prospective study sought to assess neoadjuvant Relugolix-induced sexual dysfunction prior to the initiation of stereotactic body radiation therapy (SBRT).

Methods

Prospective, patient-reported data was collected from a male cohort diagnosed with localized prostate cancer and subsequently treated with neoadjuvant Relugolix and SBRT. Relugolix was initiated at least 2 months prior to SBRT. Sexual function and bother were assessed via the sexual domain of the validated Expanded Prostate Index Composite (EPIC-26) survey which includes five function questions (erections and orgasm) and one overall bother question. Individual scores ranged from 0-100 with higher scores reflecting improved function/less bother. EPIC-26 was collected for each patient at pre-Relugolix baseline and one hour prior to SBRT initiation. Individual items were evaluated for statistical significance (paired t-test, p < 0.05) and clinical significance by minimally important difference (MID, +/- 0.5 SD from baseline score).

Results

Between July 2021 and January 2023, 49 patients with localized prostate cancer were treated with neoadjuvant Relugolix (4-6 months) and SBRT (36.25-40 Gy in 5 fractions) at Georgetown University Hospital per institutional protocol IRB 12-1775. The median age was 73 years. 27% of patients were black and 26.1% were obese (BMI ≥30 kg/m2). Patients initiated Relugolix at a median of 3.6 months prior to SBRT. 82% of patients had intermediate risk disease. All individual EPIC sexual function scores declined in a similar manner following neoadjuvant Relugolix therapy. These declines were both statistically and clinically significant. There was no statistically or clinically significant change in the EPIC sexual overall bother score.

Conclusions

In concordance with known side effects of ADT, neoadjuvant Relugolix was associated with a significant decline in self-reported sexual function. However, patients indicated only a minimal and non-significant increase in bother. Relugolix was well-tolerated as patients on Relugolix did not subjectively find their sexual dysfunction troublesome. Future investigations should compare outcomes while on Relugolix directly to GnRH agonist-induced sexual dysfunction.

Disclosure

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(305) Contemporary Therapies in Oncofertility: Identifying the Common Consults
Authors: Mallory C , Lorduy S , Staley L , Ligon J , Halpern J , Potts S , Campbell K
Published: February 2024

Introduction

Fertility inquiries among chemotherapy, immunotherapy, and targeted therapy regimens are increasing in volume and heterogeneity of referrals. There is limited research highlighting the prevalence of contemporary oncologic therapies seen by urologists and patient-specific fertility concerns.

Objective

This study seeks to identify the most common contemporary chemotherapy, immunotherapy, and targeted therapy regimens referred to urology for oncofertility inquiries and concerns.

Methods

We performed a retrospective single institutional review of all oncologic agents referred to the department of pediatric hematology oncology for fertility evaluation over the past five years (April, 2018- April, 2023). These included both frontline and salvage treatments. Agents were defined as contemporary if drug approval was received by the Food and Drug Administration 2006 or later.

Results

We identified 75 patients who underwent 28 unique contemporary agents ranging across 16 different drug classes referred for fertility evaluation (Figure 1). The majority of agents referred were used by 1-2 patients. The most common agents for oncofertility consultation included the monoclonal antibody Brentruximab (9), immune checkpoint inhibitor pembrolizumab (8), and T-cell engager Bilinotumomab (8). The most common agents included immune checkpoint inhibitors (16), monoclonal antibodies (16), and tyrosine kinase inhibitors (15).

Conclusions

There is significant variability and diversity among modern oncologic agents among patients referred for oncofertility evaluation, demonstrating the need for provider familiarity and future research in the oncofertility space.

Disclosure

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(310) Severe Delayed Skin Reaction to Antiseptic Irrigation Solution Managed with Pinch Skin Grafting After Inflatable Penile Prosthesis Surgery: A Case Report
Authors: Freudenburg E , Yafi F , Hammad M
Published: February 2024

Introduction

Inflatable penile prosthesis (IPP) surgery is a common procedure for treating erectile dysfunction, and skin preparation with antiseptic solutions is a standard practice to reduce infection risk. However, some antiseptic solutions, such as chlorhexidine-based Irrisept, have been associated with severe skin reactions. Several studies have reported cases of contact dermatitis, blistering, and chemical burns following the use of chlorhexidine-based antiseptic solutions before surgery.

Objective

This case report aims to highlight the potential risk of severe skin reactions when using Irrisept and other chlorhexidine antiseptic solutions during penile prosthesis surgery. It also explores the novel technique of pinch skin autografting used to salvage the implant and achieve successful wound healing after delayed skin necrosis.

Methods

61-year-old male with a history of prostate cancer and erectile dysfunction who underwent insertion of an IPP.

Results

The patient's penile shaft developed blisters 3 weeks post-implantation, which progressed to full-thickness necrosis despite conservative treatment. The distribution and location of the reaction led to the hypothesis that it was caused by the chlorhexidine-based Irrisept antiseptic. The antiseptic solution used copiously throughout the case and 10CC was injected under pressure into the drain which also may explain the reaction observed. The patient underwent wound debridement and was treated with pinch skin autografts from the bilateral thighs. The autografts resulted in 95% epithelialization with excellent cosmetic outcomes with no other complications. To the best of our knowledge, this is the first reported case of Irrisept-induced delayed skin necrosis and the use of pinch skin grafting to salvage the implant after penile prosthesis surgery.

Conclusions

Skin reactions to Irrisept antiseptic solution during penile prosthesis surgery are rare but can be severe. Surgeons should be cautious and consider alternative skin preparation methods in patients with a history of skin allergies or sensitivities. This case also highlights the potential of pinch skin autografting as a salvage technique for post-IPP skin reactions. A multidisciplinary approach involving reconstructive burn surgeons and specialty wound care teams may be beneficial in optimizing outcomes in such cases.

Disclosure

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(314) Combing Penile Venous Stripping and Bilateral Varicocelectomy Benefit Patients with Erectile Dysfunction Secondary to Prostatectomy
Authors: Hsu G , Chueh J
Published: February 2024

Introduction

Albeit present human penile anatomy has remained unchanged for three thousand centuries and extensive study has been conducted on anatomical architecture and male potency reconstructive strategies for many centuries, it might not above be sustainable.

Objective

Given only evidence can speak volumes, and practice is the criterion for testing truth, we sought to report an innovative circumferential approach for fulfilling penile erection restoration and morphology reconstruction on an ambulatory basis microsurgical in recent years

Methods

From October 2013 to October 2020, 33 men aged 21–59 underwent penile venous stripping (PVS) and corporoplasty via a circumferential approach on an ambulatory basis. The abridged five-item version of the International Index of Erectile Function (IIEF-5), erection hardness scales (EHS), and cavernosography were used for assessment, as required. The PVS entails stripping one deep dorsal vein and two cavernosal veins after every specific emissary vein is microscopically ligated closest to the outer tunica, whereas the para-arterial veins are segmentally ligated. Subsequently, a tunic corporoplasty is conducted before and after artificial erection with autologous venous wall bi-layered patches, whereby a water-tight running suture is undertaken for the inner layer and interrupted for the second layer for idealizing penile morphology using 6-0 nylon.

Results

The average follow-up period was 5.1±1.3 years, and the surgery time was 5.2±1. 4 hours, respectively. The radiopacity was unexceptionally enhanced postoperatively. There was a significant difference (P<0.01) between the preoperative (9.8±2.7) vs. Postoperative IIEF-5 scores (20.7±2.3). The EHS improved on at least one scale. The penile shape (<10°) was deemed reported in 93.9% (31/33) patients.

Conclusions

This combination of physiologically penile venous stripping and an anatomy-based corporoplasty is ideally suited to the simultaneous restoration of penile erectile function and morphological reconstruction via a circumferential approach.

Disclosure

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(318) Factors Influencing Compliance with Trimix, an Intracavernosal Injection for Erectile Dysfunction: A Retrospective Analysis
Authors: Best J , Ledesma B , White J , Molina M , Ramasamy R
Published: February 2024

Introduction

Trimix, an intracavernosal injection therapy, is an effective treatment for erectile dysfunction. However, patient compliance with Trimix use is crucial for treatment success, and factors influencing compliance are not well understood.

Objective

This retrospective analysis aimed to identify factors that influence compliance with Trimix therapy among patients with erectile dysfunction. Additionally, the study aimed to investigate the impact of comorbidities, specifically diabetes and prostate cancer, on the duration of Trimix treatment.

Methods

Patient data from pharmacy records between 2017 and 2022 was analyzed. Custom Python code was used to calculate the duration of Trimix use based on the first and last prescription refill events. A comprehensive chart review was conducted to collect additional patient-related data, including demographics and comorbidities. Cox Proportional Hazards Regression models were employed to assess the effects of predictor variables on the duration of Trimix use. Simple linear regression was used to compare the presence of diabetes, prostate cancer, or both on time spent on Trimix treatment.

Results

The analysis included a total of 4,072 patients. Age was identified as a significant predictor of Trimix therapy discontinuation, with every additional year of age associated with an increased hazard ratio of 1.007 (p < 0.001). Preferred language also emerged as a significant predictor, with patients preferring Spanish exhibiting a higher hazard ratio of 1.163 compared to patients preferring English (p = 0.004). In terms of comorbidities, the presence of prostate cancer significantly differed from other organic causes of erectile dysfunction on time spent on Trimix treatment (p = 0.002), resulting in 80 fewer days of Trimix treatment.

Conclusions

This retrospective analysis revealed that age and preferred language are important factors influencing compliance with Trimix therapy. Older patients and those preferring Spanish were more likely to discontinue Trimix treatment. Additionally, the presence of prostate cancer significantly impacted the duration of Trimix treatment. These findings emphasize the need for age-specific counseling, language-concordant interventions, and tailored approaches to address comorbidities such as prostate cancer. Understanding these factors is vital for optimizing treatment adherence and efficacy in patients with erectile dysfunction.

Disclosure

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(346) Simultaneous Bladder Drainage via Suprapubic and Urethral Catheters: Which Drains More Completely and Why?
Authors: Naser-Tavakolian A , Sandhu S , Masterson J , Dallmer J , Bresee C , Zaliznyak M , Zhao H , Garcia M
Published: February 2024

Introduction

Reconstructive urologists often place both a urethral and suprapubic catheter intraoperatively to prevent extravasation of undrained urine across anastomosis sutures. As no consensus exists on which catheter drains the bladder more completely, many surgeons leave one catheter to gravity drainage and cap the other postoperatively.

Objective

We sought to identify differences in catheter urine outflow during dual bladder drainage with suprapubic and urethral catheters in postoperative urology patients.

Methods

Urine output (UOP) from transgender men who underwent Stage II Phalloplasty with urethral lengthening was retrospectively reviewed. Both 16 French urethral and suprapubic catheters were placed to gravity drainage postoperatively. UOP from each catheter was recorded separately, twice daily. Mixed model regression modeling tested for differences in urine output by time of day (day/night) and activity status (Bedrest: Postop Day 0-2, Ambulatory: Postop Day 3+).

Results

The aggregate number of 12-hour shift UOP observations was 250 (125 for urethral and 125 for suprapubic catheters) across 14 inpatients. Suprapubic catheters had a mean 410 ml higher output than urethral catheters per 12-hour shift (p=0.002; 95% CI: 185, 636 ml). During daytime, suprapubic catheters demonstrated higher UOP than urethral catheters per 12-hour shift (Estimated Difference: 464 ml; p=0.002; 95% CI: 211, 718 ml). During nighttime, a similar phenomenon was observed (Estimated Difference: 356 ml; p=0.009; 95% CI: 104, 606 ml). When comparing mean UOP from each catheter during the Bedrest Phase, suprapubic catheters averaged an estimated 295 ml higher UOP compared to urethral catheters per 12-hour shift with a trend toward statistical significance (p=0.052; 95% CI -3, 594 ml). During the Ambulatory Phase, mean suprapubic catheter UOP was an estimated 472 ml higher than urethral catheters per 12-hour shift (p=0.009; 95% CI 142, 802 ml) (Table 1).

Conclusions

Simultaneous bladder drainage with urethral and suprapubic catheters shows greater drainage from the suprapubic catheter (35% vs 65%). The difference in urinary drainage is likely explained by the suprapubic catheter tip and drainage inlet residing in a more gravity-dependent location, within the funnel-shaped bladder neck (Figure 1). When using two catheters, both can be placed to gravity to maximize bladder drainage as the suprapubic catheter can drain residual urine not adequately drained by the urethral catheter.

Disclosure

No.