bluuebunny/crossref_metadata_2025_split huggingface dataset:
(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

Abstract

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
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(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

Abstract

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 &gt;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

Abstract

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 &lt; 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

Abstract

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 &lt;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

Abstract

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

Abstract

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 = &lt;50 g, Q2 = 51-80, Q3 = 81-120, Q4 = &gt;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 &gt; 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

Abstract

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

Abstract

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: &lt; 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

Abstract

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.