bluuebunny/crossref_metadata_2025 huggingface dataset:
(162) IT’S TIME TO THINK GREEN: COULD WE REDUCE SEXUAL MEDICINE SURGERY’S CARBON FOOTPRINT?
Authors: Mass Lindenbaum M , Ljubetic BM , Harlamova D , Miller A , Bole R , Bajic P
Published: December 2024

Introduction

Efforts to reduce carbon footprints have been increasing in recent years as concern about the environmental impact of healthcare grows.

Objective

This preliminary study aims to quantify the carbon footprint associated with waste produced in sexual medicine surgeries.

Methods

In the months of May and June 2024, the type, practice location (hospital or surgery center), and total amount of waste in each procedure were recorded. Procedures included inflatable penile prosthesis implantation, malleable prosthesis implantation, and plaque excision and grafting. The waste in the trash bag was weighed by the attending surgeon using a luggage scale. We also recorded the amount of waste sent to recycling and the amount produced by the anesthesia team as separate measurements. In our center, the waste produced in the surgical setting is eliminated by high-temperature incineration. The carbon footprint was calculated by subtracting the amount of recycled waste reported per procedure and then using an emission factor of 0.949 (0.949 Kg. of carbon dioxide emissions (CO2e) for every Kg. of waste incinerated).

Results

The waste produced in 4 different types of sexual medicine surgeries was recorded during this period. The total weight was 100.1 lbs, with an average of 16.68 (+/- 3.79) lbs. The average weight produced by the anesthesia team was 2.92 (+/- 1.78) lb. The average weight of waste that went to recycling was 1.32 (+/- 0.55). The weights broken down by procedure and the carbon footprints are shown in Table 1.

Conclusions

Quantifying the extent of waste production in surgical procedures is crucial. A better understanding of the carbon footprint of sexual medicine practice is essential to working towards mitigation strategies. This study opens up opportunities for further investigation into the environmental impact of elective surgery and developing strategies for carbon emission reduction.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific.
(163) VIABILITY OF TARGETED SCREENING FOR STAPHYLOCOCCUS AUREUS AND MRSA AS A SUBSTITUTE FOR UNIVERSAL PREOPERATIVE INFLATABLE PENILE PROSTHESIS NASAL SCREENING
Authors: Alvermann T , Atwater BL , Gross MS
Published: December 2024

Introduction

Staphylococcus aureus (SA) and Methicillin-resistant Staphylococcus aureus (MRSA) are significant and preventable sources of inflatable penile prosthesis (IPP) infection. SA and MRSA nasal carriers have increased risk of healthcare-related infections. Screening and prompt decolonization for nasal carriers of SA in the hospital setting has been shown to reduce postoperative SA hospital-associated surgical-site infections.

Objective

We determined if known epidemiologic risk factors for SA and MRSA were prevalent in our IPP patients who tested positive for SA or MRSA at their preoperative visit. Our hypothesis was that these determinants would help identify at-risk patients to better target preoperative SA and MRSA screening in the future.

Methods

This is a retrospective IRB-approved analysis of 62 asymptomatic patients who screened positive for either SA (n = 56) or MRSA (n = 6) via nasal culture prior to undergoing IPP placement at two hospitals in our practice. These two groups were evaluated separately to compare the presence of risk factors present for SA and MRSA prior to nasal screening. Known risk factors for SA include: intravenous drug use, diabetes, recent hospitalization within 30 days, immunocompromised status, healthcare employment, hemodialysis, HIV positive status, and prior prosthetic implant placement. Known risk factors for MRSA patients include: intravenous drug use, living in a correctional facility, residential home, or shelter, occupation as a veterinarian, recent influenza-like illness and/or severe pneumonia, concurrent skin/soft tissue infection, and history of MRSA. We examined the presence of these risk factors in patients who screened positive for nasal colonization to determine if they could have undergone targeted nasal screening.

Results

Our data are shown in Table 1. We found that the most common indicator for SA colonization in our population was diabetes in 16 of 56 patients (28.6%). We found the most common MRSA-specific risk factor was a history of MRSA in 1 of 6 patients (16.7%). No patient in this prescreened and pretreated cohort subsequently had IPP infection.

Conclusions

No known risk factor for SA and MRSA colonization was found to be widely prevalent in our SA and MRSA patient cohorts. Targeting screening based on known epidemiologic risk factors for SA and MRSA would not have been a useful substitute for universal preoperative nasal screening in our population. Universal preoperative nasal SA and MRSA screening and treatment may be a useful tool to potentially diminish postoperative IPP surgical-site infections.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, MenMD.
(164) AN UPTICK IN IPP INFECTIONS WITH 0.05% CHLORHEXIDINE GLUCONATE
Authors: Bonakdar Hashemi M , Guillen Lozoya A , Ziegelmann M , Kohler T , Helo S
Published: December 2024

Introduction

The optimal irrigation solution with inflatable penile prosthesis (IPP) remains controversial.

Objective

We sought to determine the impact of the type of fluid used for dipping and irrigation (D&I) on the risk of IPP infections.

Methods

This is a retrospective, consecutive cohort study that includes individuals who underwent initial Coloplast IPP insertion or revision between January 2021 and May 2024. Cases done from January 2021 to August 2022 (20 months) underwent Rifampin/Gentamycin for dipping and Vancomycin/Gentamycin for irrigation (Group 1), whereas those from October 2022 to May 2024 (20 months) utilized 0.05% chlorhexidine gluconate for both D & I (Group 2). Surgeon, operative time, age, diabetes mellitus (DM), perioperative level of HbA1C, history of acute urinary retention (AUR), positive urine culture, and oral antibiotic (AB) regimen at discharge were obtained. The rate of infection between the two study groups and the association of risk factors with developing infection were explored by t-test and chi-square analysis for continuous and discrete variables, respectively. P-value less than 0.05 was considered statistically significant.

Results

In comparison of two study groups, infection rate was significantly higher in group 2 at 2.5% (8/314) than group 1 which did not have any infection (0/280) (P = 0.008). There was no significant association between the study group and operative time (P = 0.45), DM (P = 0.29), HbA1C level (P = 0.20) and AUR (P = 0.87) or surgeon (Table 1). Notably, two clinical infections were from non-virulent organisms (Streptococcus Constellatus & Staphylococcus Lugdunensis). Two of three patients undergoing malleable salvage failed. Since no infection was observed in group1, infection risk predictors were only analyzed in group 2. The patients in group 2 were stratified based on their diabetes mellitus (DM) status, and analyses were conducted to investigate the effect of a positive DM history on the risk of infection. The results indicated that having DM significantly increased the risk of infection, with 75% (6/8) of patients with DM developing an infection compared to 26% (78/306) of those without DM (P = 0.006) (Table 2). Notably, three of eight infections occurred in patients discharged on Augmentin or cefdinir secondary to drug interaction warning (our typical post op prophylaxis is Bactrim or ciprofloxacin).

Conclusions

Type of antiseptic fluid for D&I and DM were associated with IPP infection following surgery in our patient cohort.

Disclosure

No.
(165) NOVEL INSIGHTS ON PERIOPERATIVE ANTIMICROBIAL PROPHYLAXIS PATTERNS FOR INFLATABLE PENILE PROSTHESIS: FINDINGS FROM A LARGE MULTINATIONAL COLLABORATIVE
Authors: Hammad MAM , Azad B , Gross MS , Swerdloff D , Miller J , Abou Chawareb E , Andrianne R , Burnett AL , Gross K , Hatzichristodoulou G , Lentz A , Osmonov D , Jones A , Modgil V , Perito P , Hotaling JM , Park SH , Pearce I , Sadeghi-Nejad H , Sempels M , Suarez-Sarmiento Jr. A , Van Renterghem K , Warner JN , Ziegelmann M , Hsieh TC , Jenkins L , Jones J , Simhan J , Yafi FA ,   on behalf of the PUMP (Prosthetic Urology Multi-institutional Partnership) collaborators, Barham DW
Published: December 2024

Introduction

Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries.

Objective

We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries.

Methods

We conducted a retrospective analysis of 5,400 patients (4,187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries.

Results

For patients undergoing primary IPP placement, 81.9% received IV antibiotics for <24 hours whereas 18.1% received IV antibiotics for >24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection.

Conclusions

This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.
(167) INFLATABLE PENILE PROSTHESIS INFECTION IN DIABETIC PATIENTS ON SODIUM-GLUCOSE TRANSPORT PROTEIN 2 INHIBITORS
Authors: Wahlstedt E , Schardein J , Horns JJ , Vichare V , Das R , Hotaling J , Gross K
Published: December 2024

Introduction

Infections following inflatable penile prosthesis (IPP) placement occur in 1-3% of patients, with increased rates among diabetic patients. Attempts to predict infections using markers like glycosylated hemoglobin, glucose levels, and insulin dependence have yielded inconclusive results. Sodium-glucose transport protein 2 inhibitors (SGLT2i) are among the most commonly prescribed medications in diabetic patients and are associated with possibly increased rates of urinary tract and genital infections. The relationship between SGLT2i and IPP infections in diabetic patients has not yet been explored.

Objective

Our objective is to identify if diabetic patients taking SGLT2i are at increased risk of an IPP infection.

Methods

We performed a retrospective review of all diabetic men who underwent IPP placement utilizing MarketScan insurance claims database between 2011-2021. Patients with a diagnosis of diabetes whose medication use we were unable to identify were excluded. Demographic data, including age, smoking status and obesity were obtained. All cases of IPP infection requiring device removal were identified based on ICD-9/10 and CPT codes. Multivariate model outputs were performed to assess the likelihood of IPP infection in diabetic patients on SGLT2i as well as based on demographics.

Results

A total of 2,383 privately insured diabetic patients who underwent IPP placement were identified. The mean age of the cohort was 61 years (55-66 years), with 18.9% identified as smokers and 61.0% classified as obese. Among these patients, 883 (31.1%) were using a SGLT2i or combination medication. Over a mean follow-up period of 25 months (10-49 months), there were 82 (2.9%) documented cases of infections requiring IPP removal, which included 28 (3.2%) patients on SGLT2i and 54 (2.8%) patients on other medications. SGLT2i use was associated with a nonsignificant increase in the HR [1.26 (p = 0.39)], while smoking and obesity were both associated with significantly increased HRs [2.20 (p < 0.01) and 2.024 (p = 0.02), respectively].

Conclusions

These results suggest that preoperative counseling and lifestyle changes, particularly smoking cessation and weight loss, are important to potentially decrease the risk of IPP infections in diabetic patients. Tobacco screening and treatment, nutritional assessments, and guided weight loss plans should be integrated into preoperative management strategies prior to IPP surgery. SLGT2i may be continued perioperatively to ensure appropriate glycemic control as these medications have not been found to be associated with a significantly increased risk of postoperative infections.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Paterna bio, firmtech, Turtle health, maximus, carrot, inherent bio.
(171) A NOVEL PLACEMENT OF INFLATABLE PENILE PROSTHESIS PUMP IN THE MONS FAT
Authors: Lai L , Sessine M , O Hollaren K , Liaw A
Published: December 2024

Introduction

The utility of an inflatable penile prosthesis (IPP) can be highly influenced by good positioning of the IPP pump. Traditionally, the IPP pump is placed in the dependent portion of the scrotum. However, manipulation of the IPP pump placed in the scrotum can be difficult for some men with a large pannus or unhelpful body habitus. While some have advocated for mons fat excision with simultaneous placement of IPP, we chose to leverage patient anatomy by placing IPP pumps in the mons fat pad such that the IPP pump can be easily accessible.

Objective

To evaluate the feasibility and outcome of placing IPP pumps in the mons fat pad of obese patients.

Methods

A right groin incision next to the mons pubis was made and a subcutaneous pocket in the mons fat pad was developed using blunt dissection. The pump was placed in the subcutaneous pocket and secured with permanent suture. The tubing was tunneled to the penoscrotal incision and connected as per the traditional approach.

Results

A total of three patients have undergone IPP pump placement in the mons fat pad (Fig. 1). One patient had a de novo IPP placement and two patients had an IPP revision due to difficulty reaching the pump within the scrotum. At a follow-up of 6-24 months, the pump remained easily accessible by the patients and the IPP remained functional (Fig. 2). None had developed prosthetic infection or erosion.

Conclusions

Placing the IPP pump in the mons fat pad is safe and reproducible. This novel placement of the IPP pump in the mons fat pad represents an alternative option for patients whose anatomy may hinder the control of IPP pumps placed in the scrotum. Further research is needed to understand long-term outcomes.

Disclosure

No.
(181) MODIFIED LOCAL AND REGIONAL PUDENDAL NERVE BLOCK AT TIME OF PENILE PROSTHESIS INSERTION
Authors: Kalidoss S , Fenton D , Velasquez D , Washington S , Suarez-Sarmiento A , Perito P , Raheem O
Published: December 2024

Introduction

The Insertion of penile prosthesis can be associated with significant post operative pain often requires significant narcotics use in patients. Several post operative pain regimens have been adapted to reduce pain in the post operative period for penile prosthesis.

Objective

IIn this video, we demonstrated a step-by-step technique using modifications of several local anesthetics use at time of penile prosthesis surgery including regional pudendal nerve blocks.

Methods

IIn this video, we demonstrated a step-by-step technique using modifications of several local anesthetics use at time of penile prosthesis surgery including regional pudendal nerve blocks.

Results

These local and regional anesthetics techniques can be used by urologists to improve post operative pain level in patients receiving penile prosthesis and improve overall outcomes.

Conclusions

These local and regional anesthetics techniques can be used by urologists to improve post operative pain level in patients receiving penile prosthesis and improve overall outcomes.

Disclosure

No.
(185) MORPHOLOGICAL ANALYSIS OF TRANSGENDER TUNICA ALBUGINEA
Authors: Colombo A , Deng J , Kocjancic E , Acar O , Ohlander S , Harrington D , Mcvary K , Podlasek C
Published: December 2024

Introduction

The tunica albuginea plays a critical role in the biomechanics and physiology of the penis, as the main bearer of mechanical forces, especially during erection. Collagen fibers represent a key element of the tunica albuginea strength, however the collagen composition of the tunica remains poorly understood despite its critical role in disease development (erectile dysfunction and Peyronie's).

Objective

In this study, analysis of tunica morphology was performed on tissue from transgender patients, in order to identify the types of collagen/collagen composition of the tunica.

Methods

Transgender tunica tissue (n = 18) was obtained from patients undergoing penectomy surgery for gender reassignment. Immunohistochemical (IHC) analysis for collagen 1-2, -3 and -4, and trichrome stain were performed to characterize the collagen subtypes and abundance. Primary cell cultures were established from transgender tunica and cultures were characterized with IHC analysis for P4HB (fibroblast), alpha-ACTIN (smooth muscle), CD31 (endothelium) and nNOS (neurons). Tunica cell growth was quantified in response to Sonic hedgehog (SHH) pathway signaling.

Results

Trichrome stain identified the undulating structure of the tunica, which predominantly contained collagen fibers, and rare smooth muscle cells, in contrast to the corpora cavernosa which contained abundant collagen and smooth muscle. IHC analysis identified collagen 1, 2 and 4 in the tunica, but collagen 3 was not observed.

Conclusions

Characterization of tunica morphology in healthy patients is important to understand the mechanophysiology of the tunica. This morphological analysis identified the collagen subtypes present in patient tunica tissue and is a first step in understanding how diseases of the tunica develop. Comprehension of how collagen remodeling occurs would be useful for development of novel treatments for Peyronie’s disease.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Uronext LLC.
(187) T LYMPHOCYTES IN HUMAN SEMEN: INSIGHTS INTO IMMUNE TOLERANCE OF SPERMATOGENESIS
Authors: Stocks B , Oppenheimer A , Huang J , Lipshultz L
Published: December 2024

Introduction

Emerging preclinical work has demonstrated the requisite role of the adaptive immune system in maintaining tolerance toward “foreign” spermatozoa. As seen in animal models, breaks in this system directly causes male factor infertility. Depletion of tolerogenic T lymphocytes induces severe autoimmune orchitis, immune cell infiltration, and reduced sperm number and motility.

Objective

There exists no investigation of the adaptive regulatory immune system in the context of human male fertility. We interrogated our seminal fluid cryobank which consists of 1700 patient samples to study this highly relevant question in male fertility.

Methods

We identified 15 semen samples with increased round cells on semen analysis. Patient samples were thawed, fixed and permeabilized, and stained with the nuclear fluorescent stain DAPI. This differentiates DAPI dim spermatozoa [haploid] from DAPI bright leukocytes [diploid]. Cells were then stained with fluorescently conjugated antibodies (CD45, CD3, CD4, CD25 and Foxp3) to identify leukocytes and specifically, tolerogenic CD4 T Regulatory Cells (CD4 Tregs). Multiparameter flow cytometric analysis was performed (BD LSRFortessa) and data analyzed using GraphPad Prism Software.

Results

CD45 positive leukocytes as identified by flow cytometry ranged in frequency from 0.003% to 2.93% +/- 0.88% and correlated positively with WBC counts on semen analyses. We were able to reliably identify Foxp3+ CD4 Tregs in semen samples. Increased frequencies of CD4 Tregs were observed in patients with higher seminal fluid WBC counts. Interestingly, CD4 Treg frequencies were inversely correlated with sperm density and motility [p < 0.05 linear regression].

Conclusions

We describe the first report of tolerogenic T lymphocytes studied in human semen. We reliably identified and documented increased frequencies of CD4 Tregs in patients with lower sperm density and motility. CD4 Tregs expand in inflammatory conditions to quell ongoing autoimmunity. Overall, we hypothesize that inadequate control of autoreactive anti-sperm lymphocytes by tolerogenic CD4 Tregs leads to poor sperm quality. Further mechanistic investigation of this paradigm remains highly warranted.

Disclosure

No.
(189) MORPHOLOGICAL ANALYSIS OF TRANSGENDER PENIS
Authors: Deng J , Triko A , Colombo A , Kocjancic E , Acar O , Ohlander S , Harrington D , Mcvary K , Podlasek C
Published: December 2024

Introduction

Erectile dysfunction (ED) is a serious medical condition that impacts quality of life. An underlying cause is loss of cavernous nerve (CN) innervation, which initiates remodeling of the corpora cavernosa of the penis including smooth muscle apoptosis and increased collagen. There are few studies of penile remodeling in patient tissue because of low availability of patient corpora cavernosa specimens, and in acquiring appropriate controls, however it is critical to ensure that our animal models adequately parallel patient conditions.

Objective

In this study a detailed analysis of penile morphology was performed on corpora cavernosa tissue from transgender patients in comparison to Peyronie’s controls, in order to determine if corpora cavernosa from transgender patients may be useful as a control for morphological studies of the human penis.

Methods

Transgender penis tissue (n = 18) was obtained from patients undergoing penectomy surgery for gender reassignment. Corpora cavernosa tissue was obtained from Peyronie’s (control, n = 8) patients that were undergoing prosthesis implantation. Immunohistochemical analysis for alpha-ACTIN, CD31, P4HB, and nNOS were performed to characterize the transgender tissue in comparison to Peyronie’s controls. Trichrome stain, hydroxyproline assay, and western analysis for alpha-actin (smooth muscle) and GAPDH, were performed to examine smooth muscle retention and collagen abundance. Primary cell cultures were established from transgender and Peyronie’s corpora cavernosa, and growth in response to SHH, BMP4 and GREM1 treatment were quantified. The effect of 17 □-estradiol on smooth muscle cultures were examined.

Results

Normal smooth muscle, endothelium, fibroblasts, neural tissue, collagen, and SHH signaling in corpora cavernosa from transgender patients was found in comparison to Peyronie’s controls. 17 beta-estradiol treatment did not alter smooth muscle cell growth or the response to SHH pathway signaling.

Conclusions

Transgender patients typically undergo 17 beta-estradiol treatment prior to penectomy. While there have been studies which document the effects of estrogen on penile embryogenesis and hypospadias, little is known about the effect estrogen may have on adult corpora cavernosa tissue. In this study a detailed analysis of penile morphology was performed in transgender patients in comparison to Peyronie’s controls, in order to determine if the transgender tissue may be useful as a control for patient studies of corpora cavernosa morphology. No apparent difference in penile morphology was observed between Peyronie’s and transgender patients. While further study is needed, transgender corpora cavernosa tissue may be useful as a control for studies of patient penile morphology.

Disclosure

No.
(202) CERAMIDE TEST IN PATIENTS WITH ERECTILE DISFUNCTION TO ASSESS CARDIOVASCULAR RISK
Authors: Guillen A , Dumbrava M , Bonakdarkashemi M , Ziegelmann M , Helo S , Kohler T
Published: December 2024

Introduction

Erectile dysfunction (ED) is a known precursor and sequelae to diagnosed cardiovascular disease (CVD). ED severity predicts CVD severity. AUA guidelines recommend evaluating serum lipids and using an ED diagnosis as an opportunity to discuss and address cardiovascular risk. Serum plasma ceramides are novel predictors of adverse cardiovascular events independent of traditional risk factors such as LDL and hsCRP levels. Ceramide levels improve with lifestyle modification.

Objective

We aimed to evaluate the utility of ceramide levels in ED patients utilizing self-reported erectile function results (IIEF-6).

Methods

We initiated ceramide testing in all patients with ED and Peyronie’s disease in late 2019 (in addition to lipids, Hgba1c, etc). We retrospectively analyzed ceramide levels from electronic records with IIEF-6 results. For the statistical analysis we dichotomized our cohort by ED symptom severity (moderate/severe ED: IIEF ≤17 vs. no/mild ED: IIEF ≥18) and ceramide levels by CV risk strata (moderate or higher >6). A Fisher exact test was performed.

Results

A total of 354 patients were reviewed, of these 253 (71.4%) had moderate ED or higher. A statistically significant difference in abnormal ceramide values was found in patients with mild to moderate symptoms severity or higher, and the odds of getting an abnormal ceramide test was increased based on the IIEF scoring alone (OR 2.3 [1.04– 5.12]; p value = 0.034) [Figure].

Conclusions

Patients undergoing management for erectile dysfunction may benefit from serum ceramide testing and subsequent cardiac referral. In our cohort, men with moderate to severe ED were twice as likely to have actionable ceramide levels. Further study is warranted to optimize utility of ceramide in men with ED and potentially drive lifestyle change.

Disclosure

No.
(205) ASSOCIATION OF TESTOSTERONE REPLACEMENT THERAPY WITH ATRIAL FIBRILLATION AND ACUTE KIDNEY INJURY
Authors: Panken E , Greenberg DR , Kohn T , Asanad K , Brannigan RE , Halpern JA
Published: December 2024

Introduction

Secondary analyses of the Testosterone Replacement Therapy for Assessment of Long-Term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) trial revealed significantly higher rates of new-onset atrial fibrillation (AF) and acute kidney injury (AKI) in the TRT cohort.

Objective

To validate the secondary findings of the TRAVERSE trial.

Methods

We utilized the TriNetX Research Network to identify a cohort of men ages 45-80 years old who met similar inclusion criteria to the TRAVERSE trial. We compared hypogonadal men (testosterone 100-300 ng/dL) who had a prescription for topical testosterone therapy and men who did not. Propensity score matching was used to match patient populations. Kaplan Meier survival analysis was used to determine the relative risk of new-onset AF and AKI within 3 years.

Results

There were 2,134 men included in each cohort after propensity score matching. There was no significant difference in age or race/ethnicity between cohorts. Men on TRT had significantly lower T at the time of diagnosis compared to men not prescribed TRT (207 ± 66 ng/dl vs 246 ± 140 ng/dl, p < 0.001). Kaplan–Meier survival analysis showed a significantly increased risk AKI among men on TRT (RR 1.53, 95% CI 1.07-2.18). However, TRT was not associated with a significantly increased risk of new-onset AF (RR 1.48, 95% CI 0.93-2.37).

Conclusions

Similar to the TRAVERSE trial, our study demonstrated an increased risk of AKI among men on TRT, but did not find an increased risk of AF. Further studies are required to validate these findings.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Posterity Health.
(211) EFFECT OF ANDROGEN RECEPTOR POLYMORPHISM ON HYPOGONADISM SEVERITY
Authors: Mills N , Saffati G , Orozco Rendon D , Song W , Khera M
Published: December 2024

Introduction

The preferred treatment for hypogonadism, testosterone replacement therapy (TRT), has a varying efficacy that is currently not understood. This observation may be explained by polymorphism of the androgen receptor (AR), a ligand-binding transcription factor whose polyglutamine tract length affects various health conditions and androgen sensitivity. It has been theorized that this polymorphism may also affect severity of hypogonadism.

Objective

This study sought to determine a correlation between hypogonadism severity and number of CAG trinucleotide repeats in the AR gene.

Methods

17 males presenting to Baylor College of Medicine with symptoms of hypogonadism were recruited for this study. PHQ-9 and IIEF-15 surveys were taken upon initial visit. Patients’ testosterone (T) levels were measured before starting TRT. CAG repeat length was determined via polymerase chain reaction (PCR) followed by Sanger sequencing. Linear regression and nonparametric Wilcoxon testing (RStudio) were performed to test for a correlation between measured parameters.

Results

Average number of CAG repeats found was 23 ± 3.1, which is within the normal range as described by current literature. No correlation was found between: PHQ-9 score and CAG repeat length (p = 0.8543), PHQ-9 score and baseline (endogenous) T levels (p = 0.1680), IIEF-15 score and CAG repeat length (p = 0.4650), IIEF-15 score and baseline T levels (p = 0.9301), [EF] subscore and CAG repeat length (p = 0.5404), [EF] subscore and baseline T levels (p = 0.9159), or T levels and CAG repeat length (p = 0.3624). Half of the patients (n = 8) had [EF] subscores <14, indicating erectile dysfunction. However, Wilcoxon testing reveals that this difference is not significantly less than the cutoff (p = 0.4375), a result likely due to the small sample size. These findings are consistent with the literature, which suggests that a correlation between CAG repeat length and erectile function only exists in eugonadal men.

Conclusions

These data suggest that CAG repeat length may not serve as an accurate measure of hypogonadism severity. Additionally, baseline T levels did not significantly correlate with symptom severity in this small population. More research with a larger sample size is needed to determine the relationship between CAG repeat length, hypogonadism, and TRT efficacy. Additionally, genotyping of the polyglycine tract, another repeat region downstream of the polyglutamine tract, is ongoing, which may reveal more about this novel approach to understanding the mechanism behind TRT.

Disclosure

No.
(215) THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: ROBUST III STUDY 4-YEAR INTERIM RESULTS
Authors: Morey A , Elliott S , Coutinho K , Robertson K , D'anna R , Chevli K , Carrier S , Aube-Peterkin M , Cantrill C , Ehlert M , Te A , Dunn J , Delong J , Brandes S , Hagedorn J , Levin R , Schlaifer A , Virasoro R , Demarco D , Erickson B
Published: December 2024

Introduction

The ROBUST III study is a randomized controlled trial comparing the Optilume® Drug Coated Balloon (DCB) against direct visual internal urethrotomy (DVIU) or dilation. The Optilume® Drug Coated Balloon (DCB) is a dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Outcomes after 4-year follow-up are presented here.

Objective

To determine long-term endpoints after Optilume® DCB including freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax).

Methods

127 subjects were randomized in a 2:1 fashion at 23 sites. Seventy-nine were treated with the DCB and 48 were treated with DVIU or dilation. Follow-up past 1 year was limited to those treated with the DCB. Eligibility criteria included adult males with anterior strictures with ≥2 prior treatments and stricture length ≤ 3 cm.

Results

Subjects randomized to receive the DCB had an average of 3.2 prior treatments and average stricture length of 1.6 cm (46% ≥ 2 cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS significantly improved from 21.9 at baseline to 12.6 at 4 years. Qmax significantly improved from a baseline of 7.7 mL/sec to 13.2 mL/sec at 4 years. Freedom from repeat intervention for DCB subjects was estimated to be 71%. No late-onset treatment related adverse events were observed.

Conclusions

The Optilume® DCB continues to achieve significant improvements in symptoms, flow, and reintervention rates through 4 years post treatment.

Disclosure

Yes, this is sponsored by industry/sponsor: Laborie.

Clarification: Industry funding only - investigator initiated and executed study.
(217) IMPACT OF PROSTATE VOLUME AND PREOPERATIVE URINARY RETENTION ON URINARY INCONTINENCE FOLLOWING HOLMIUM LASER ENUCLEATION OF PROSTATE
Authors: Cole R , Khoei A , Daignault-Newton S , Knuth E , Wei J
Published: December 2024

Introduction

HOLEP is an increasingly popular modality for men with BPH and associated LUTS. While studies show that post-operative urinary incontinence returns to baseline following HOLEP, existing research has not been completed utilizing comprehensive validated UI questionnaires. In addition, the associations between prostate size or pre-operative retention on post-operative incontinence are not well studied. Current theories include the notion that larger prostate size (with retention as a correlate) may lead to increased manipulation and damage to the external sphincter during the procedure. Confirmation or negation of such risk factors for post-operative incontinence may guide surgeons in pre-operative counseling for shared-decision-making to reach patient satisfaction.

Objective

Our objective was to evaluate the impact of prostate size and preoperative retention on postoperative incontinence by utilizing the AUASS and Michigan-Incontinence Symptom Index (MISI) before and 1 and 6 months after HOLEP. MISI is a validated UI questionnaire with score of 0-32, with higher score indicating worse symptoms.

Methods

We retrospectively reviewed 627 males who underwent HOLEP at our institution by a single surgeon between 2014-2022, of which were included. We excluded 300 patients without both pre and 6-month post-operative MISI scores; 15 others were missing prostate size. Our primary outcome was ISI score comparison. AUASS were also compared to confirm validity of our results. Prostate size was grouped into quartiles (Q1 = <50 g, Q2 = 51-80, Q3 = 81-120, Q4 = >120) and retention was categorized into “with” or “without” prior to surgery. Retention was defined as patients with any form of catheterization. Wilcoxon rank test was used to evaluate the association of postoperative urinary symptoms with prostate size and retention.

Results

Of 627 subjects, median age was 70 years old and median prostate size was 81 grams, with range of 16.6 and 350. 24% of patients were identified to have urinary retention. MISI score medians are 3 points at baseline, 11 points and 1 month, and 4 points at 6 months. MISI scores from baseline to 6-month assessment were not associated with prostate size (p = 0.2) nor pre-operative retention (p > 0.8). Changes at 1-month assessment were also not associated with either variable (Fig. 2a, 2b).

Conclusions

With utilization of validated urinary incontinence questionnaires, we confirm that urinary incontinence may worsen in the immediate post-operative period and return to baseline by 6 months. Unlike other studies, we conclude that neither prostate size nor preoperative urinary retention had an impact on self-reported incontinence. Thus, such factors may not be critical to include in patient selection for HOLEP when considering post-operative incontinence risks.

Disclosure

No.
(235) ARE PATIENTS UNDERGOING INTRALESIONAL INJECTION THERAPY FOR PEYRONIE’S DISEASE COMPLIANT? A SEVEN YEARS ANALYSIS FROM A TERTIARY CARE MEN’S HEALTH CENTER
Authors: Lumbiganon S , Yafi F , A Moukhtar Hammad M , Abou Chawareb E , Azad B , Nakamura H
Published: December 2024

Introduction

Peyronie's disease (PD) poses significant challenges to men, adversely affecting their quality of life due to pain, functional impairments, and cosmetic concerns. Intralesional injection of Clostridium Collagenase Hystolyticum (CCH) has become a preferred treatment option for PD, yet there is a lack of comprehensive data regarding patient compliance with this care.

Objective

This study aimed to examine the demographics of patients undergoing CCH therapy for PD and assess their compliance and treatment outcomes.

Methods

A retrospective review of 573 consecutive patients with PD, presenting to a men’s health clinic during October 1,2017 to September 30, 2023 was conducted. The analysis encompassed patient demographics, treatment strategies, and outcomes. Patient compliance was defined as completion of at least 4 cycles of CCH therapy or satisfaction with the treatment result. Descriptive statistics were employed for data analysis.

Results

Among the 573 patients analyzed, 292 had CCH therapy. Eighty-three had surgery (44 patients underwent penile prosthesis surgery), 43 reported using a traction device, and 214 did not receive any interventions. Of the 292 patients undergoing CCH therapy, the mean composite curvature was 43.0 ± 13.1% compared to 42.8 + 16.4 in no CCH group. Ninety-two patients (31.5%) received CCH fewer than 4 cycles. One hundred fifty-two (52.1%) completed 4 cycles, and 42 (14.4%) underwent more than 4 cycles. The overall mean composite curvature improvement in the CCH group was 21.2 + 14.9 degrees, or 48.4 ± 31.5%. Reasons for incomplete completion of 4 cycles included satisfaction with outcomes in 16 (17.4%), CCH-related adverse effects in 15 (16.3%) including 4 suspected penile fractures, active co-morbidities in 8 (8.7%), lack of improvement in 7 (7.6%), 3 of these pursued to surgery, insurance policy changes in 6 (6.5%), and unidentifiable causes in 40 (43.5%). Accordingly, based on our definition, loss of compliance was noted in 76 out of 292 patients (26.0%).

Conclusions

This study suggests relatively poor compliance in men undergoing CCH therapy for PD. A better understanding of these findings is needed to improve compliance and optimize outcomes in this cohort.

Disclosure

No.
(236) HOW OFTEN DO PATIENTS ELECT SURGERY FOLLOWING XIAFLEX TREATMENT FOR PEYRONIE’S DISEASE?
Authors: Schommer J , Qosja N , Haehn D , Regele E , Hampton S , Qualkenbush E , Baird B , Aldridge H , Ball C , Broderick G
Published: December 2024

Introduction

Peyronie’s disease (PD) is a fibrosing condition of the tunica albuginea characterized by a palpable plaque with varying impacts on the patient’s erection: curvature, shortening, indentations, hinging, and concentric narrowing. Stepwise intralesional injection of collagenase clostridium histolyticum (Xiaflex) is the only FDA approved medical treatment for PD. We retrospectively reviewed Xiaflex treated patients for satisfaction with therapy or pursuit of subsequent surgery.

Objective

To assess satisfaction of Xiaflex treatment without subsequent surgical intervention.

Methods

This is a retrospective review of patients presenting with PD to a single center and managed by a single provider with six-month follow-up after treatment. Patient presentations were recorded in an Institutional Review Board approved database. Data storage and analytics were conducted using REDCap.

Results

The cohort for this study was 81 men treated with intralesional Xiaflex. 71.6% of patients (58/81) were satisfied with Xiaflex outcomes and sought no further therapy. 27.2% of patients (22/81) were not satisfied with their outcomes and 12 (14.8%) elected subsequent surgical interventions: 6 penile plications, 2 incision and graftings and 4 inflatable penile prostheses. 63.3% of patients had full (8) Xiaflex treatment. Among the 50 who had full Xiaflex treatment, 12% had surgery after Xiaflex. Among the patients who had partial Xiaflex treatment 20.7% had surgery following Xiaflex. The degrees of curvature in patients receiving Xiaflex was: < 60 (n = 42), ≥ 60 (34) and hourglass deformity (n = 4). Among the 12 patients who had surgery following Xiaflex, 6 men received 8 Xiaflex treatments, and 1 patient each received 2, 4, 5, 6, and 7 Xiaflex treatments.

Conclusions

If successful medical management of Peyronie’s disease is defined by men who do not seek subsequent surgical intervention following therapy, Xiaflex was highly successful. In our series of 81 patients, only 14.8% sought surgical interventions following intralesional collagenase histolyticum.

Disclosure

No.
(237) INVESTIGATING THE EFFECTS OF ACTINIDIN AS A COLLAGENASE ON HUMAN PEYRONIE’S DISEASE CELLS
Authors: Feng K , Kiattiburut W , Burton J , Campbell J
Published: December 2024

Introduction

Peyronie's Disease (PD) is a condition characterized by a connective tissue disorder that affects the penile tunica albuginea, leading to the formation of collagen-rich plaques. These plaques can cause penile curvature, painful erections, and erectile dysfunction. With the withdrawal of Collagenase C. histolyticum injections from the Canadian market, treatment options for PD have become limited. Actinidin, a soluble enzyme capable of breaking down various forms of collagen and fibrinogen, has shown effectiveness in reducing collagen in human in vitro cell models.

Objective

To assess the cytotoxicity of actinidin and evaluate its efficacy in reducing intercellular bound collagen in a 2D cellular human Peyronie's disease plaque models.

Methods

A 2D cellular model was cultured using human fibroblast cells isolated from PD tissues (N ≥ 4). Actinidin treatment was prepared using isolated actinidin powder in media, filtered, and adjusted to pH 7. Cells were treated with 10 ng/ml of TGF-β to induce a PD-like cellular model for 24 hours and then exposed to actinidin concentrations ranging from 1 mg/ml to 20 mg/ml. Media-only and TGF-β-only controls were included. Cell proliferation was assessed at 24 hours at various actinidin concentrations using an MTT assay. Collagen I levels were quantified through western blot analysis after 24 hours of treatment. Results were analyzed using oneway Anova analysis.

Results

Results from both the cell proliferation and collagen I quantification revealed that TGF-b significantly increases cell proliferation (P = 0.042) and collagen I levels (P = 0.018). After treating the cells with various concentrations of actinidin, the cell proliferation assay revealed that cell viability at 20 mg/ml was significantly lower (P = 0.038) compared to the TGF-β control. Additionally, a trend was observed where cell proliferation appeared to slightly decrease at higher concentrations of actinidin, although there was no significant difference in cell viability between the other treated concentrations and the TGF-β control. Western blot analysis showed that Collagen I levels were significantly reduced after 24 hours of actinidin treatment at concentrations of 10 mg/ml and 20 mg/ml.

Conclusions

Our continuation preliminary results demonstrate that actinidin can reduce collagen I levels in PD cells. However, high doses of actinidin cause cell destruction, so we recommend that treatment should not exceed 20 mg/ml. Future studies will investigate the molecular mechanism by which actinidin hydrolyzes collagen and will evaluate its effects in an animal model. Given the lack of durable FDA-approved treatments for PD in Canada, this novel approach holds significant potential for future treatment options.

Disclosure

Yes, this is sponsored by industry/sponsor: KiwiEnzyme.com Ltd.

Clarification: No industry support in study design or execution.
(238) THE USE OF EVARREST(TM) FIBRIN SEALANT PATCH IN PEYRONIE'S GRAFTING
Authors: Dwyer K , Furuyama W , Johnsen N
Published: December 2024

Introduction

Complex and severe Peyronie’s disease often requires operative management with plaque incision/excision and grafting. Grafting materials have varied from autologous saphenous vein grafts to porcine small intestinal submucosa and cadaveric pericardium. Recently, the use of TachoSil collagen fleece has been shown to be successful. In 2012, Evarrest Fibrin Sealant was FDA approved. It has since demonstrated superior hemostatic properties and easier intraoperative use in liver and other solid organ surgeries.

Objective

Herein, we describe our institution’s experience with 20 patients who underwent plaque incision and grafting with Evarrest. We sought to demonstrate the feasibility of its use and describe associated complications.

Methods

This study was conducted via retrospective chart review at a single academic institution. A single surgeon’s case logs between 2020 and 2024 were obtained for all patients with CPT Code 54112, Plaque Incision and Grafting. Of this group, 20 patients were identified who underwent Evarrest grafting. These charts were then reviewed to determine the preoperative characteristics of their disease including curvature severity and direction and postoperative outcomes.

Results

The mean age was 59 ± 9 years (range 44-79) with a mean curvature of 69 degrees. Direction of curvature was most commonly dorsal (n = 14). Nine patients had a concomitant hourglass deformity. Two patients had bothersome plaques without curvature. For most patients, this was their first intervention (n = 15). After incision/excision of the plaque, defect size ranged from 1x3cm at the smallest up to 3.5x8cm at the largest. Two patients underwent simultaneous inflatable penile prosthesis placement. Penile straightening was achieved in 80% of patients, with 3 reporting mild residual curvature and 1 with severe recurrent curvature. Six patients reported numbness or paresthesia, documented at visits between 3-4 months postoperatively. Two patients had wound infections requiring oral antibiotics, and two had hematomas that required drainage.

Conclusions

The use of Evarrest Fibrin Sealant for Peyronie’s plaque incision and grafting procedures is feasible with acceptable post-operative outcomes. As Evarrest is more durable and easier to manipulate than Tachosil, it may serve as an appropriate alternative grafting option.

Disclosure

No.