bluuebunny/crossref_metadata_2025 huggingface dataset:
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims
Authors: Mowlem Florence D. , Tenaerts Pamela , Gwaltney Chad , Oakley-Girvan Ingrid
Published: May 2022

Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however—except for one—these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.
Review of Machine Learning Approach on Credit Card Fraud Detection
Authors: Bin Sulaiman Rejwan , Schetinin Vitaly , Sant Paul
Published: May 2022

Massive usage of credit cards has caused an escalation of fraud. Usage of credit cards has resulted in the growth of online business advancement and ease of the e-payment system. The use of machine learning (methods) are adapted on a larger scale to detect and prevent fraud. ML algorithms play an essential role in analysing customer data. In this research article, we have conducted a comparative analysis of the literature review considering the ML techniques for credit card fraud detection (CCFD) and data confidentiality. In the end, we have proposed a hybrid solution, using the neural network (ANN) in a federated learning framework. It has been observed as an effective solution for achieving higher accuracy in CCFD while ensuring privacy.
Comparison of the Effects of Intravenous Sedatives on Outcome in Adult Critically ill Patients: a Bayesian Network Analysis
Authors: Xu Jing-Yuan , Wu Zong-Sheng , Chang Wei , Lu Zhong-Hua , Yang Yi
Published: May 2022

Background

This Bayesian network analysis was performed to assess the effects of different intravenous sedatives on outcomes in adult critically ill patients.

Methods

We searched for and gathered data from MEDLINE, Cochrane Central Register of Controlled Trials, Elsevier and Web of Science databases. Bayesian network analysis was performed to evaluate the effect of different intravenous sedatives on outcome in adult critically ill patients. Random errors were evaluated by trial sequential analysis (TSA).

Results

Twenty-seven studies including 8,599 critically ill adult patients were enrolled in the analysis. Comparisons among lorazepam, midazolam, propofol, dexmedetomidine, haloperidol and placebo or usual care were presented in a network plot. No significant differences were found for longest mortality in critically ill patients. However, when compared with midazolam, dexmedetomidine had a shorter ICU length of stay and a lower incidence of delirium. Meanwhile, midazolam had a longer ICU length of stay when compared with placebo, propofol and usual care. Subgroup analyses were performed respectively in sepsis, invasive ventilated patients and postoperative patients, as well as patients with higher severity of disease. Lower mortality was found in dexmedetomidine group when compared with placebo in postoperative patients. No differences were found for mortality, ICU length of stay and incidence of delirium in other subgroups. When compared with other sedatives, dexmedetomidine shortened ICU length of stay significantly in ventilated patients. TSA indicated lack of firm evidence for a beneficial effect.

Conclusions

No differences were found for longest mortality of different sedatives in adult critically ill patients. However, when compared with midazolam, dexmedetomidine had a shorter ICU length of stay and a lower incidence of delirium. TSA indicated lack of firm evidence for the results. More powered, randomized, controlled trials are needed to determine the effects.
082 Efficacy and Safety of Hyaluronic Acid Filler Injection as Compared to Polylactic Acid Filler for Temporary Penile Augmentation: A Multi-Center, Patient/Evaluator-Blinded, Randomized Control Trial with a Safety Extension
Authors: Ahn ST , Cho SB , Lee HS , Han DE , Lee DH , Shim JS , Kim SW , Moon DG
Published: May 2022

Introduction

Soft tissue augmentation using hyaluronic acid (HA) filler has grown rapidly in recent years, while clinical studies, especially randomized control trial, in penile augmentation (PA) using HA filler rarely conducted.

Objective

This study aimed to investigate the efficacy and safety of HA filler injection for temporary PA as compared to polylactic acid (PLA) filler.

Methods

The present prospective, patient/evaluator-blinded, multi-center study randomized 74 patients with small penis syndrome, which defined as the anxiety felt when one's penis is being observed because of concern that the penis is small, to HA filler injection or PLA filler injection for PA. Penile girth and satisfaction, were assessed at baseline and at 4, 12, and 24 weeks after injection. Safety profile evaluation was extended for 48 weeks for HA filler injection group.

Results

Grossly, both filler materials were evenly distributed, and led to a significant volume expansion for up to 24 weeks post-injection (Figure 1) In both group, mean penile girths significantly increased at 4 weeks post-injection (2.7±1.0 and 2.3±1.1 cm mean increases in the HA and PLA groups, respectively; each p<0.001). Although, both filler gradually decreased, penile girth increases adequately lasted for 24 weeks (2.3±1.3 and 2.0±0.9 cm mean increases from baseline in the HA and PLA groups, respectively; each p<0.001). (Figure 2) Satisfactions for penile appearance and sexual life were significantly increased at 24 week in both group. Adverse event related to filler injection were reported in 2 (5.56%) and 3 (7.89%) patients in HA and PLA groups, respectively during 24 weeks. And 1 case was recorded after extensions for 48weeks for HA group.

Conclusion

HA filler was similarly effective with PLA filler for temporary PA in men with small-penis syndrome and can be used safely for a long time until 48 weeks.
100 Long Term Impact of LDR Brachytherapy for Prostate Cancer on Erectile Function: Single Centre Tertiary Referral Outcomes with 8-Year Follow Up
Authors: Katelaris A , Browne L , Bucci J , Malouf D , Thompson J
Published: May 2022

Introduction

Low dose rate (LDR) brachytherapy is an established treatment for localised low and intermediate risk prostate cancer, whereby multiple radioactive seeds are permanently implanted into the prostate. Brachytherapy is considered to be a less invasive option with a more favourable side effect profile compared to radical prostatectomy. Erectile dysfunction (ED) is still common after brachytherapy further understanding of this relationship would enable enhanced patient counselling.

Objective

To assess rate and severity of ED following LDR Brachytherapy monotherapy for low and intermediate risk prostate cancer in a tertiary referral centre.

Methods

We conducted a retrospective observational cohort study of patients who underwent LDR Brachytherapy as monotherapy in our institution between 2002 -2019. We extracted and analysed data from a prospective database obtaining baseline demographic data and simplified International Index of Erectile Function (IIEF-5) scores at regular intervals during follow up. The proportion of patients in each IIEF-5 category: severe ED (<12), moderate ED (12-16), mild ED (17-21) and no ED (22-25) were recorded at baseline, at regular intervals for up to 8 years. The degree of ED was assessed by calculating the mean differences between baseline (n=1017) and values at various timepoints; 6 weeks (1-3 months, n=905), 6 months (3-9 months, n=884), 1 year (9-18months, n=838), 2 years (18-30 months, n=705), 3 years, (30-48 months, n=561), 5 years (48-72 months, n= 489) and 8 years (72-120 months, n=262).

Results

A total of 1491 suitable patients were identified. Baseline IIEF scores were available for 1017 patients. The median age was 63 (40-84), with 98% of patients being between 50 and 80. The proportion of patients with severe ED doubles at 6 weeks, and remains similar throughout the duration of follow up, as can be seen in Figure 1. The distribution of IIEF-5 scores overtime are seen in figure 2. Compared to baseline, at 6 weeks the mean difference in IIEF score is -6.37 (p<0.001), which is also similar to the remainder of the follow up period, with a mean difference of -7.45 at 8 years (p<0.001). These results are seen in Table 1.

Conclusion

Patients who underwent LDR brachytherapy experienced a mild, early decline in sexual function, which may be explained by the implantation procedure. Sexual function then remained relatively stable with no significant further late deterioration over the subsequent 5-10 years, aside from a slight decrease which would be expected with aging. The majority of patients with no dysfunction at baseline experienced at least mild early and long-term ED over time. We plan to build on this study by conducting multi-variate analysis for predictors of ED post brachytherapy.
101 Testosterone (T) Challenge in Men Post-Radical Prostatectomy (RP) with Profoundly Low Testosterone
Authors: Martinez J Flores , Mulhall JP , Deveci S , Matsushita K , Torremade J , Salter CA
Published: May 2022

Introduction

Prostate specific antigen is the primary marker of prostate cancer recurrence. PSA secretion is T dependent with T levels below saturation point associated with sub-optimal PSA production. Men with an undetectable PSA level after RP with very low T levels might have an artificially low PSA level.

Objective

We aimed to evaluate the effects of raising T level in such men.

Methods

Study population consisted of (i) men post-RP (ii) with undetectable PSA level (iii) total T levels <200 ng/dl (two levels, LCMS) who (iv) underwent in-office intramuscular injection of 100mg of T cypionate (v) had a PSA level checked 5 days later, and if undetectable every month after that, 3 months later then every 6 months and (vi) follow-up of at least 24 months on T therapy.

Results

22 men have been challenged thus far. Mean age 62±18 years. Mean preoperative PSA 6.2. Mean post-RP TT value 140± 35 ng/dL 2.2. Median Gleason sum 7. 23% had GS ≥8. Mean post-RP, pre-challenge T value 140± 35 ng/dL. Mean time post-RP to challenge was 7± 9 months. Mean TT value 5 days after IMT challenge 640± 220 ng/dL, all with TT levels above 400. 5/22 has a PSA elevation, 2 immediately after IMT challenge (PSA values 0.07, 0.08). All other men started T therapy immediately and had PSA elevation at 9, 14 and 22 months after commencing T therapy (PSA values 0.08, 0.12, 0.11). All patients with PSA elevation had continued rise in PSA and had detectable disease on imaging. All men with PSA recurrence had either GS 7 with unfavorable pathology (2) or GS ≥8 (3).

Conclusions

This T challenge approach permits the early detection of prostate cancer recurrence permitting early intervention. About 10% of such men had a PSA rise immediately after T challenge.

Disclosure

Work supported by industry: no.
114 Novel 3D MRI Fusion Penile Imaging Modality for Peyronie's Disease: A Pilot Study
Authors: Pincus J , Lerner M , Sanekommu G , Ottaiano N , Raheem O
Published: May 2022

Introduction

Penile imaging for Peyronie's disease (PD) can be challenging. Traditional cross-sectional imaging modalities such as computerized tomography (CT) or magnetic resonance imaging (MRI) can delineate and characterize pathological penile anomalies; however, limitation in imaging interpretations do exist. Optimal imaging of the penis aids in surgical planning and patient counseling.

Objective

In this study, we aim to utilize a novel three-dimensional (3D) MRI fusion penile imaging modality for men undergoing surgical reconstruction for PD.

Methods

Men with PD, palpable plaques, and deformed corpora were included in this study. We obtained preoperative cross-sectional MRI penile images and Sexual Health Inventory for Men (SHIM) Questionnaire (SHIM) scores on all included patients. We fused MRI images with Ceevra (Ceevra, Inc., San Francisco, CA, USA) 3D imaging software to develop detailed imaging aiding surgical reconstruction. 3D models were used for preoperative patient counseling and surgical planning as well as intraoperatively.

Results

A total of six patients were included, 3 African American men and 3 White men. The mean age was 65 and mean BMI was 35. There was no difference in preoperative SHIM scores (4 severe and 2 mild erectile dysfunction). Preoperative MRI images were fused with Ceevra software to develop detailed 3D models of corporal plaques and its related structures. The 3D models were easily accessible to surgeons during preoperative clinic visits and at time of reconstruction (Figure 1).

Conclusions

In this study, 3D MRI fusion penile imaging for PD has emerged as a potential preoperative advanced imaging modality useful for preoperative counseling and planning, especially in complex PD cases. Further evaluation is prerequisite to evaluate its potential role in aiding intraoperative decision making.

Disclosure

Work supported by industry: no.
128 Long-Term Outcomes of Testosterone Replacement Therapy for Patients with Late-Onset Hypogonadism Syndrome
Authors: Ohira S , Jo T , Kakumae S , Nakatsuka T , Morinaka H , Takasaki H , Hirata K , Sugiyama S , Shimizu S , Kaifu M , Fujii T , Miyaji Y , Nagai A
Published: May 2022

Introduction and Objective

Testosterone replacement therapy (TRT) is effective for patients with late onset hypogonadism (LOH) syndrome. However, treatment compliance of long-term TRT for LOH syndrome patients remains unclear. We investigated the long-term outcomes of TRT for patients with LOH syndrome.

Methods

Forty-two patients (age: mean 55.9, SD 10.2) were diagnosed and then underwent TRT using testosterone enanthate between January 2010 and December 2014 at our hospital. We investigated long-term compliance of TRT, changes of subjective data, i.e. aging male symptom (AMS score) and, international index of erectile function (IIEF5), and objective data, i.e. free testosterone level and, serum PSA level, retrospectively. This study was approved by the Ethics Committee of our facility (Approval No.3043).

Results

At the time of TRT initiation, AMS score (mean, as mentioned below) was 55.1 (SD 10.1) points, IIEF5 was 7.9 (SD 3.8) points, free testosterone level was 5.8 (SD 1.9) pg/ml, and serum PSA level was 1.3 (SD 1.6) ng/ml. The duration of TRT was 27.7 (SD 29.4) months. Dose of testosterone enanthate was 183.1 (SD 69.2) mg/4weeks. AMS score and IIEF5 were significantly improved after TRT. Adverse events (AE) occurred in 9.6% of the patients, but these were no severe AE. TRT continuation rate was 50.0% at 12 months, 40.5% at 24 months, 35.7% at 36 months, and 33.3% at 48 months. In addition, there was a significantly higher rate in the group with severe AMS scores than in mild-moderate groups. In the discontinuation group of 25 patients (59.5%), the duration of treatment was significantly longer in the improvement group than in the ineffective group.

Conclusions

Testosterone replacement therapy for late onset hypogonadism syndrome is a safe and effective long-term treatment. The treatment continuation analysis showed that patients with severe AMS scores and better effect of TRT requested long-term treatment.

Disclosure

Work supported by industry: no.
140 Effect of Androgen Replacement Therapy on Erectile Function Through Histological Recovery in Castrated Rats
Authors: Kataoka T , Hotta Y , Kimura K
Published: May 2022

Introduction

Androgens are essential for physical activity in males and normal erectile function. Reportedly, androgen deficiency causes erectile dysfunction through tissue damage in the corpus cavernosum. We previously reported that delayed androgen replacement therapy improved erectile function in rats through histological recovery.

Objective

To investigate the mechanism of the recovery process by androgen replacement therapy in rats.

Methods

Twelve-week-old male Wistar ST rats were used in this study. The rats were assigned to the following groups: castrated (Cast), castrated with subcutaneous administration of testosterone undecanoate (25 mg/kg; Cast+T), and sham (Sham). Cast+T rats received subcutaneous doses of testosterone, beginning from 4 weeks after castration, whereas Sham and Cast rats received only the vehicle. Erectile function was assessed by evaluating intracavernosal pressure (ICP) and mean arterial pressure (MAP) after electrical stimulation of the cavernous nerve at 1, 2, 4, and 8 weeks after testosterone administration. mRNA expression of histological factors (Cavin-1, Cavin-2, Cavin-3, α-SMA, VEGF-R, ICAM-1, and TGF-β1) was tested using real-time PCR.

Results

The ratio of ICP to MAP was 0.26 ± 0.04 in the 4th week for the Cast group, and the erectile function was significantly lower than that of the Sham group (0.61 ± 0.03; p <0.05). On the other hand, in the Cast+T group, it changed over time from 0.41 ± 0.06 in the 1st week, 0.44 ± 0.04 in the 2nd week, 0.48 ± 0.04 in the 4th week, to 0.70 ± 0.03 in the 8th week, and erectile function was significantly improved 8 weeks after the testosterone administration (p <0.05). The Cavin-1 and Cavin-2 mRNA expressions were increased in the Cast+T group compared to the Cast group at all times (P <0.01). α-SMA, VEGF-R, ICAM-1, and TGF-β1 mRNA expressions were also increased in the Cast+T group, as compared to the Cast group (P <0.01).

Conclusions

In this study, we identified that androgen replacement therapy in rats would improve ED. This may be because the administration of testosterone improved histological recovery. It has been reported that these caveolae-related factors control the invagination structure of the cell membrane, and that caveolae in endothelial cells are also involved in the production of nitric oxide (NO), which might contribute to the therapeutic effect of androgen replacement therapy. Increase in the expression of these caveolae-related factors may regenerate smooth muscle and corpus cavernosum structures.

Disclosure

Work supported by industry: no.
141 A Meta-Analysis of Psychological Factors and Pain Catastrophizing of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Authors: Huang X.
Published: May 2022

Introduction

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a chronic disease with a variety of psychosocial and somatic symptoms. CP/CPPS has substantial health care costs with unclear etiology, which may be caused by psychosocial factors. Moreover, previous studies suggested that cognitive processes played a crucial role in the perception of somatic pain.

Objective

Therefore, the aim of this meta‑analysis was to analyze the psychosocial characteristics in men with CP/CPPS, especially the symptom of pain catastrophizing.

Methods

Relevant publications were searched in different databases including PubMed, MEDLINE, EMBASE, Google Scholar and the Cochran Library using the search terms of “Chronic prostatitis”, “Chronic pelvic pain syndrome”, “Psychosocial” and “Catastrophizing”. The prevalence of psychological factors and pain catastrophizing in men with CP/CPPS were extracted and calculated.

Results

Ten studies inclusive of 1,308 patients were included. Analysis of NIH‑CPSI scores showed that the severity of CP/CPPS was 23.20 (95% CI: 21.13–25.28). The severity of pain catastrophizing was 13.81 (95% CI: 9.83–17.79) estimated by coping strategies questionnaire (CSQ), while the severity of pain catastrophizing was 24.83 (95% CI: 9.19–40.47) estimated by pain catastrophizing scale (PCS). The prevalence of psychosocial symptom was 0.43 (95% CI: 0.32–0.55), while the prevalence of pain catastrophizing was 0.26 (95% CI: 0.21–0.31).

Conclusions

The psychological factors and pain catastrophizing in men with CP/CPPS was serious.

Furthermore, the prevalence of psychosocial symptom and pain catastrophizing was high. There might be a link between pain catastrophizing and somatic symptoms in CPPS. Thus, further prospective studies are needed to evaluate the importance of psychosocial factors in symptom severity of CP/CPPS.

Disclosure

Work supported by industry: no.
145 Evaluating the Impact of Time Between Radical Prostatectomy (RP) and Adjuvant Radiation Therapy (RT) on Erectile Function Recovery (EFR)
Authors: Martinez J. Flores , Benfante N. , Schofield E. , Mulhall J.P.
Published: May 2022

Introduction

RT post-RP in men with PSA recurrence improves survival. It is also associated with a higher rate of urinary incontinence and erectile dysfunction (ED).

Objective

We attempted to evaluate if the time period between RP and adjuvant RT predicts EFR outcomes.

Methods

Men who received RT post-RP with ≥2 years post-RT follow-up were analyzed. ADT and RT pre-RP were exclusions. Demographics, comorbidities and pathological parameters and IIEF erectile function domain (EFD) scores were recorded. We report median EFD scores and factors correlated with EFR ≥24 months post-RT. Factors included: patient age, comorbidities, smoking status, baseline pre-RP and pre-RT Testosterone (T), prostate specific antigen (PSA), baseline EFD score, Nerve-Vascular bundle (NVB) status, and time between RP and RT.

Results

126 men were included. Mean age at RP was 63 ± 7 years. Mean pre-RP T was 390 ± 222 ng/dL, PSA, 10.2 ± 10.4 ng/mL and median EFD score were 27 (IQR = 20-30). Median pre-RT T was 376.9 ± 187 ng/dL, PSA 0.25 ± 0.33 ng/mL, and median EFD score was 9 (IQR = 3-20). 54% of patients had bilateral NVB preservation, and 29.5% unilateral. 71% received ADT with their RT, the median duration of ADT exposure was 4.5 (IQR = 3-8.5) months. Median time between RP and RT was 14.9 months (IQR = 8.5-28.6) months; 41% had ≤1 year between RP and RT. 2 years post RT, median EFD was 9.5 (IQR = 3-22). 22% had a score ≥24. EFD score at follow-up was correlated with age at RP (r=-0.32, p<.001), and pre-RT EFD score (r=0.56, p<.001). Time between RP and RT did not correlate with EFD score at follow up (r=0.08, p=0.39).

Conclusions

In our prostate cancer patients cohort post-RP/RT, EFR is lower; almost 4 of 5 patients will have some ED degree at two years post-RT. The period time between RP and RT is not correlated with EFR post-RT.

Disclosure

Work supported by industry: no.
153 Surveillance of Sexual Function After Robot-Assisted Laparoscopic Radical Prostatectomy
Authors: Shimizu S. , Jo T. , Kakumae S. , Nakatsuka T. , Morinaka H. , Hirata K. , Takasaki H. , Sugiyama S. , Ohira S. , Kaifu M. , Fujii T. , Miyaji Y. , Nagai A.
Published: May 2022

Introduction and Objectives

Sexual dysfunction is one of the main factors that affects for quality of life (QOL) after prostatectomy. Previous research showed that sexual dysfunction after laparoscopic radical prostatectomy (LRP) was caused at 1 month, and refractory sexual dysfunction persisted for a long time. In recent years, robot-assisted laparoscopic radical prostatectomy (RALP) has been introduced at a large number of medical facilities. This time, we investigated change of sexual function after RALP using questionnaires related to sexual function.

Materials and Methods

Thirty-two patients were diagnosed localized prostate cancer and underwent RALP between January 2020 and June 2021 at our hospital. We investigated the change of sexual and voiding functions using International Index of Erectile Function (IIEF5), Expanded Prostate Cancer Index Composite (EPIC) at the time of diagnosis, 1, 3, 6, 12 month after RALP, and daily use numbers of urinary pad at 1, 3, 6, 12 month after RALP. Control was set at the time of diagnosis. This study was approved by the Ethics Committee of our facility (Approval No.3906-00).

Results

Patient age (median) was 67.5 (range 50-80) years old, body mass index (median) was 22.5 (range 17.4-28.7) kg/m2, and serum PSA (median) was 7.5 (range 4.0- 31.9) ng/ml at the time of diagnosis. Clinical stage T1c was accounted for 7 cases, T2a was 9 cases, T2b was 3 cases, T2c was 11 cases, and T3a was 2 cases. Fourteen patients (43.8%) underwent nerve-sparing RALP. IIEF5 and sexual function domain of EPIC showed deterioration at 1 month after RALP. However, sexual bother domain of EPIC showed not significant difference after RALP. The relevance between change of sexual function and nerve-sparing operation were not observed at our observation period. On the other hand, daily use numbers of urinary pad were significantly improved as time passed compared with that of at 1 month after RALP. The relevance between urinary continence and nerve-sparing operation were observed at 1 month after RALP.

Conclusions

Sexual dysfunction after RALP showed the same change as that after LRP. Besides, nerve-sparing operation might affect for urinary continence instead of sexual function.

Disclosure

Work supported by industry: no.
160 Treatment and Comorbidities of Patients with Erectile Dysfunction Before and During COVID-19 in the United States: A Real-World Data Analysis
Authors: Goldstein I. , Hassan T. , Li J. , Riad M. , Vignesh S. , Zou K.
Published: May 2022

Introduction

Erectile dysfunction (ED) is usually a symptom of another medical condition. People with poor overall health are more likely to develop severe form of coronavirus disease 2019 (COVID-19) and may have unwanted symptoms such as ED. COVID-19-related stress, anxiety, and depression can also impact sexual health and possibly lead to ED. There are various treatment options for patients with ED. However, real-world evidence of the impact of COVID-19 on the treatment and comorbidities of patients with ED is limited.

Objectives

To estimate the impact of COVID-19 on the treatment and comorbidities of patients with ED in the United States.

Methods

This retrospective real-world data (RWD) analysis used the IQVIA PharMetrics® Plus claims database, which is a patient-Centric, closed claims database of fully adjudicated pharmacy, hospital and medical claims anonymized at the patient level, that captures the complete patient journey for all services billed to and covered by the patient's health plan. We compared the ED treatment and comorbidities in adult males aged 18+ years with ED in the same 3-month periods before (01March - 31May, 2019) and during (01March – 31May, 2020) the COVID-19 pandemic. ED treatment included any ED-related claims, prescriptions of any and individual phosphodiesterase-5 inhibitor (PDE5i) medications (avanafil, sildenafil, tadalafil and vardenafil).

Results

See the table below for number of patients having ED-related claims, having any and individual PDE5i prescriptions, number of patients with COVID-19 diagnosis, and percentage of patients with each of the top 10 comorbidities, in the 3-month periods before and during COVID-19.

Conclusions

RWD showed that ED-related claims significantly decreased during the COVID-19 pandemic, reflecting the pandemic's impact on ED patients’ health. However, the use of PDE5i medications remained stable during the pandemic. Key comorbidities including hypertension, hyperlipidemia, type 2 diabetes mellitus, benign prostatic hyperplasia with lower urinary tract symptoms, testicular hypofunction, and malignant neoplasm of the prostate, during the pandemic, compared with pre-pandemic period, highlighted the impact of the pandemic on ED patients’ health and need for managing their other comorbid chronic diseases.

Disclosure

Work supported by industry: yes, by Viatris. A consultant, employee (part time or full time) or shareholder is among the authors (Viatris).
162 Assessment of the Results of Treatment Erectile Dysfunction in Diabetic Patients by Tadalafil 20mg Once Every There Days
Authors: Nguyen Q. , Van H. Do
Published: May 2022

Introduction

Tadalafil (a PDE5 inhibitor) is used to treat erectile dysfunction (ED), which can be dosed on-demand or daily. Tadalafil has a long half-life, so it has a long-lasting effect. Men with ED also have a preference for a treatment that is time-independent

Aim

To evaluate the efficacy and safety of tadalafil 20 mg with a dose of one tablet every three days in the treatment of erectile dysfunction among diabetic patients.

Material and methods

A prospective study was carried out on 22 men with diabetes who were examined with symptoms of erectile dysfunction satisfying the selection criteria at Center for Andrology and Sexual Medicine - VietDuc University Hospital from June 2020 to June 2021. These patients were treated with tadalafil 20 mg once every three days.

Results

There were 22 patients included in the study, mean age was 52.1 years old. The baseline degree of erectile dysfunction was mainly mild to moderate (accounting for 73%). The average IIEF-5 score before and after treatment was 12.2 and 19.3, respectively. The improvement of IIEF-5 score was statistically significant (p <0.05). Headache was the most common side effect, accounting for 13.6%, followed by facial flushing, nasal congestion, myalgia and back pain with 9.1%, palpitations and digestive disorders with 4.5%.

Conclusion

tadalafil 20mg dosed one tablet every three days for the treatment of erectile dysfunction among diabetic patients has a statistically significant effect; hopefully, providing an additional option for the safe treatment of erectile dysfunction in diabetic patients.

Disclosure

Work supported by industry: no.
163 PDE5 Inhibitor Prescribing in Hypertension
Authors: Mita K.
Published: May 2022

Purpose

We will analyze the PDE5 inhibitor prescription at Kobe-Sannomiya EAST Ekimae Clinic(predecessor).

Methods

To analyze the type of antihypertensive drug in hypertensive patients receiving pharmacotherapy among male re-examination patients who prescribed PDE5 inhibitors more than 6 months after the initial consultation.

Results

The target 445 age groups were 5 in their 30s, 35 in their 40s, 144 in their 50s, 177 in their 60s, 79 in their 70s, and 5 in their 80s. The elapsed time from initial consultation to re-examination was 96 for 6 months or more and less than 1 year, 214 for 1 year or more and less than 2 years, and 135 for 2 years or more. The antihypertensive drugs were Ca antagonist 133 (24 other drugs other than ARB), angiotensin Ⅱ receptor antagonist (ARB) 112 (19 other drugs other than Ca antagonist), Ca antagonist and there were 186 patients with ARB (43 with other drugs) and 14 with other drugs. The breakdown of other concomitant drugs and other drugs was β-blockers, α-blockers, αβ-blockers, ACE inhibitors, and diuretics. Very few patients voluntarily complained of ED symptoms associated with taking antihypertensive drugs, and various types of antihypertensive drugs were taken.

Discussion

Even if a PDE5 inhibitor is more effective, it is necessary to consult with your GP about taking antihypertensive drugs.

Disclosure

Work supported by industry: no.
189 Ethnic Underrepresentation in Validation of Female Sexual Dysfunction Questionnaires
Authors: Redmon C. , Alzweri L.
Published: May 2022

Introduction

Female sexual dysfunction (FSD) is a significant cause of morbidity that affects an estimated 30-50% of women. FSD is characterized by conditions which cause distress in at least one area – desire, arousal, orgasm, or pain – and can be challenging to diagnose depending on the patient-provider relationship and/or individual levels of comfort in having such discussions. Several questionnaires have been developed over the past four decades to assess FSD. This repertoire of tools includes assessments of overall sexual function, quality of life, and specific dysfunctions (i.e., hypoactive sexual desire disorder).

Objective

The purpose of this review is to evaluate the ethnic representation of sample populations used in the studies to validate these questionnaires.

Methods

A literature search was performed to gather information on questionnaires that have been developed to assess FSD. Subsequent searches were targeted to obtain the published studies used to validate each tool. Collective averages from the combined ethnic data were compared to population data from US census data and healthcare workforce reports to evaluate epidemiologic diversity. Ethnicity data from each questionnaire were investigated longitudinally to evaluate trends in representation of these sample populations over the past 40 years.

Results

Nineteen questionnaires were evaluated for ethnic representation based on published validation studies. Each questionnaire was tabulated to include the domain(s) assessed, number of items in each questionnaire, validation sample population size and description, and available ethnicity breakdown for each questionnaire. The average ethnic representation of the questionnaires relative to the US general population and US female health care workforce, respectively, was: Caucasian (78.3% vs. 62.7% and 68.5%), African American (3.3% vs. 13.3% and 8.3%), Hispanic (2.3% vs. 16.0% and 9.6%), American Indian (0.0% vs. 0.8% and 0.3%), Asian (0.6% vs. 6.4% and 6.2%), and Other (0.7% vs. 0.7% and 1.4%).

Conclusions

FSD is a common condition affecting women and causes significant impacts on quality of life. Review of the sample populations used to validate the questionnaires used to evaluate FSD in routine practice shows underrepresentation of ethnic minorities when compared to general population demographics. FSD questionnaire is an important research tool, helps increase health care providers and patients awareness of FSD, in addition, eventually improving access to care for ethnic minority women.

Disclosure

Work supported by industry: no.
193 Sexual Attitudes of Turkish Population During the COVID-19 Outbreak
Authors: Sahin O. , Culha M.G. , Demir O. , Avsar M.T.
Published: May 2022

Introduction

During the worldwide COVID-19 pandemic, the psychological and mental conditions of the society worsen. The aim of this study is to examine the changes in their sex lives due to the Turkish COVID-19 outbreak.

Method

This online survey was conducted between April and June 2020 with 468 patients admitted to the hospital. After the approval was given, an online questionnaire was sent from the hospital database and from the social media accounts of health institutions (Twitter, Facebook, Instagram, WhatsApp, etc.) and e-mail addresses. The first part of the four-part questionnaire included demographic data, the second and third parts of attitudes before and after COVID-19, and the last part to assess sexual functions, sleep, anxiety and depression.

Results

The study was completed with a total of 390 participants. The response rate of the study is 83.33%. Sexual desires of healthcare workers (3.78 ± 1.03 vs. 3.07 ± 1.11; p <0.001), weekly sexual intercourse / masturbation number (2.58 ± 1.01 vs. 1.18 ± 1.01; p <0.001), duration of foreplay (19.27 ± 11.28 vs.10.12 ± 11.04; p <0.001), duration of sexual intercourse (24.65 ± 15.67 vs. 14.25 ± 15, 63; p <0.001) decreased compared to before the COVID-19 outbreak. In addition, participants preferred less foreplay (p <0.001), less oral sex (p <0.001) and anal sex (p: 0.007), and more non-face-to-face positions during COVID-19 (p <0.001) . When the factors affecting sexual dysfunction were examined as univariate and multivariate, it was shown that sexual dysfunction was significantly more common in male gender (OR: 2.048) and alcohol users (OR: 3.836). The shortcoming of the study is that the pre-COVID-19 sexual and mental states of the participants were not assessed with the validated questionnaire.

Conclusion

During the COVID-19 pandemic, the public's sexual desire decreased, the number of sexual intercourse decreased, the duration of foreplay was reduced, and the preference to be face-to-face in sexual intercourse positions decreased.

Disclosure

Work supported by industry: no.
201 Survey on Sexuality in Manhood in Japan Using an Internet Questionnaire
Authors: Tobu S. , Noguchi M.
Published: May 2022

Objective

Research on erectile dysfunction and the development of medications for erectile dysfunction has been actively carried out both in Japan and overseas. However, studies on the sexuality of Japanese men. such as the actual situation concerning intravaginal ejaculation disorder, masturbation, and the foreskin status. have been insufficient. One reason for this is because obtaining responses to questionnaires about such matters is difficult, as these are sensitive subjects. We therefore conducted a survey on sexuality in manhood in Japan using an internet questionnaire and report the findings.

Methods

Using Macromill's internet survey tool, 110 men each 20-29 (20s), 30-39 (30s), 40-49 (40s) and 50-59 (50s) years old (440 in total) were asked whether or not they had any intravaginal ejaculatory disorders, whether or not they masturbated and in what position if they did so (lying on their backs while stretching their legs or lying face-down [called prone masturbation]), the status of their foreskin (incomplete or complete phimosis) and whether or not they had ever been reluctant to associate with a partner.

Results

8.1% of respondents in their 20s, 6.8% in their 30s, 7.0% in their 40s and 8.4% in their 50s answered that they had experienced intravaginal ejaculation disorders more than once every two instances of intercourse. Regarding the position adopted for masturbation, as prone masturbation can cause intravaginal ejaculation disorder, the frequency lying on the back was 29.1% in respondents in their 20s, 30.0% in those in their 30s, 27.3% in those in their 40s and 25.5% in those in their 50s, and the frequency of prone masturbation was 6.3% in respondents in their 20s, 6.3% in those in their 30s, 0.9% in those in their 40s and 4.5% in those in their 50s. Adopting the position of lying on one's back was more prevalent than prone masturbation for each generation. However, regarding the degree of awareness of intravaginal ejaculation disorder, those who masturbated while lying on their backs accounted for 18.7% in those in their 20s, 29.4% in those in their 30s, 29.1% in those in their 40s and 40.9% in those in their 50s, while those who masturbated in the prone position accounted for 42.8% in those in their 20s, 57.1% in those in their 30s, 100% in those in their 40s and 80.0% in those in their 50s. These findings indicate that prone masturbation was significantly more associated with intravaginal ejaculation disorder than lying on one's back while stretching the legs. Regarding the foreskin status, 19.1% of respondents in their 20s, 29.1% in their 30s, 36.7% in their 40s and 40.9% in their 50s answered that the foreskin was always peeled back.

Conclusion

Despite the difficulty guaranteeing the accuracy of data obtained through questionnaire surveys using the internet compared to individually administered questionnaires, this approach seems to be very useful for surveys involving sensitive content, as in this study.

Disclosure

Work supported by industry: no.
204 Awareness Survey on Adverse Events Including Sexual Dysfunction Associated with Cancer Treatment
Authors: Ikuta H. , Fujimoto N.
Published: May 2022

Introduction

In clinical practice, we often experience differences in perceptions between patients and healthcare professionals about adverse events in cancer treatment. Some patients consider that there are adverse events that they want to avoid, even if the treatment is slightly less effective.

Objective

In order to refer to the explanation about adverse events in cancer treatment, we conducted an awareness survey on adverse events including sexual dysfunction in cancer treatment of patients.

Methods

An anonymous questionnaire survey was conducted for those who cooperated with the outpatients department of urology at our hospital and those who visited related hospitals. In the questionnaire, we decided to select the adverse events those the patient would like to avoid even if the therapeutic effect is slightly inferior in the treatment of cancer. In the questionnaire, (1)respiratory symptoms, (2)dietary symptoms, (3)symptoms related to defecation, (4)skin symptoms, (5)numbness, weakness, joint pain, (6)fatigue, decreased vitality, (7) hot flashes, (8)fever, infectious disease, (9)hair loss, (10)anxiety, depression, (11)infertility, and (12)sexual dysfunction, are listed as items of adverse events. Multiple answers were allowed for them. Regarding sexual dysfunction, we also confirmed whether or not there was a desire to see a specialist when symptoms appeared.

Results

As of July 1, 2021, the questionnaire was collected in 90 cases (74 males and 16 females). The median items selected by each respondent were 3 items (range 0-12). 73 (81.1%) respondents selected one or more items. The number of people who chose sexual dysfunction was 10 (11.1%), all of whom were male (20-39years old: 0 people, 40-59years old: 1 person, 60-69years old: 4 people, 70-79years old: 3 people, 80years old and over: 2 people). In addition, 5 (5.6%) wanted to see a specialist when sexual dysfunction appeared. Regarding other items, respiratory symptoms, dietary symptoms, defecation-related symptoms, fever and infectious diseases, were all selected by more than 45% of the respondents.

Conclusions

More than 80% thought that there were complications to avoid when treating cancer, even if the treatment was a little inferior. Among them, adverse events that directly interfere with daily life tended to be avoided more. In daily clinical practice, the frequency of patients who consider changing treatment due to sexual dysfunction in cancer treatment is low. However, in this survey, it was confirmed that a certain number emphasizes sexual dysfunction.

Disclosure

Work supported by industry: no.
210 The Effect of Antioxidant Supplementation on Operated or Non-Operated Varicocele-Associated Infertility: A Systematic Review and Meta-Analysis
Authors: Pyrgidis N. , Sokolakis I. , Palapelas V. , Tishukov M. , Mykoniatis I. , Symeonidis E.N. , Zachariou A. , Kaltsas A. , Sofikitis N. , Hatzichristodoulou G. , Dimitriadis F.
Published: May 2022

Introduction

In patients with varicocele-associated infertility, the effect of antioxidant supplementation on fertility is unknown.

Objectives

To perform a systematic review and meta-analysis exploring the role of antioxidant supplementation in patients with operated or non-operated varicocele.

Methods

We searched PubMed, Cochrane Library, Web of Science and Scopus databases, as well as sources of grey literature until May 2021 (PROSPERO: CRD42021248195). We produced a qualitative synthesis of the main results extracted from the included studies. Based on data availability, we undertook an inverse variance, random effects meta-analysis of odds ratios (ORs) to determine the pregnancy rate after antioxidant supplementation versus no treatment in patients undergoing surgical repair of varicocele at three and six months of treatment. In these patients, we determined the effect of antioxidant supplementation versus no treatment or placebo on semen parameters (concentration, motility, morphology, and DNA fragmentation).

Results

We included 14 studies (980 individuals) in the systematic review. Of the 14 studies, 2 explored the effect of antioxidant supplementation in patients with non-operated varicocele, 1 compared antioxidants versus surgical repair of varicocele, while 11 explored antioxidants after surgical repair of varicocele and were also included in the meta-analysis. Regarding pregnancy rates, no significant differences were demonstrated after treatment with antioxidants versus no treatment at three (OR: 2.28, 95% CI: 0.7–7.48) and six months (OR: 1.88, 95% CI: 0.62–5.72). Accordingly, contradictory findings were reported in sperm concentration, morphology, and motility, as well as DNA fragmentation.

Conclusions

Our findings indicate that antioxidant supplementation does not improve pregnancy rates and semen parameters in patients with varicocele-associated infertility, in the absence of previous screening for oxidative stress. Based on the previous notion, most included studies also raised methodological concerns. Therefore, definitive conclusions about the efficacy of antioxidant supplementation in this setting cannot be drawn and further research on the field is mandatory.

Disclosure

Work supported by industry: no.
219 Factors Associated with the Decrease in Orgasm Intensity in Patients Who Underwent to Radical Prostatectomy
Authors: Gamberini P , Nascimento B , Barbosa Neto C , Pedrenho R , Góes P , de Bessa Júnior J , Sphair J , Nahas W , Srougi M
Published: May 2022

Introduction

Orgasmic disorders after radical prostatectomy (RP) surgery have received increasing focus on medical literature, especially the most frequent disorders, to name but a few, climacturia and dysorgasmia. However, changes in orgasm intensity have been reported to non-negligible rates and should be better studied.

Objective

Our study aims at describing the prevalence and predictors of this neglected symptom.

Methods

We performed a retrospective analysis of a prospective maintained database of men after RP with complaints of sexual dysfunction. Patients observed a sexual medicine group of our hospital went throught a supervised visit which included the investigation of orgasmic disorders. Other factors such as erectile dysfunction, hypogonadism symptoms, seric level of testosterone and prolactin, and demographics were also recorded. Finally, these variables were correlated with the decrease in orgasm intensity, seeking to assess the existence of predictive factors for this disorder.

Results

Data from 57 patients were available considering the average age of 67 years old (65,4-68,6 CI, 95%). The decrease in orgasm intensity was reported by 14 patients (24,5%), while climacturia was related to 38 patients (68%) and dysorgasmia to one patient (1,75%). Among patients who experienced decreased orgasm intensity, the average time between the surgery and the search for our service was 27,5 months (15,6-39,4 CI, 95%). After using a logistic regression model adjusted to several variables which include age, time from the last surgery, testosterone and prolactin levels, hypogonadic symptoms, presence of climacturia or dysorgasmia, erectile dysfunction and response to IPDE-5, use of adjuvant radiotherapy or hormonotherapy, it was realized that age was the only factor associated with the lowering of orgasm intensity. The median age was significantly lower in those patients who reported a reduction in orgasm intensity, respectively 62 [59-67] x 68 [64-73] (p <0.01).

Conclusions

Orgasmic disorders after radical prostatectomy surgery have a high incidence and are often neglected. These symptoms have a direct impact on the quality of life and should be actively investigated. Our study showed that age appears to be a relevant factor associated with this condition.

Disclosure

Work supported by industry: no.