bluuebunny/crossref_metadata_2025_split huggingface dataset:
QbD-Based Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Favipiravir—An Eco-Friendly Approach
Authors: Chandana M. Siri , K. Sujatha , A. Ajitha , Narendra Pentu , K. Sonia 
Published: February 2024

Abstract

Background
Analytical quality by design (AQbD) affords a systematic scaffolding to triumph a continuously validated, robust assay as well as life cycle management. The resuscitative repurposed drug favipiravir, an oral drug approved for reemerging pandemic influenza in Japan in 2014, is used for the treatment of life-threatening pathogens such as Ebola, Lassa virus, and currently COVID-19. Favipiravir is gaining a great deal of medical importance due to its pharmaceutical applications.

Objective
To develop and validate a risk-based stability-indicating RP-HPLC method employing an AQbD approach using Central Composite Design (Design Expert Software 13.0) for the estimation of favipiravir.

Method
The Quality Target Product Profile optimized were flow rate and mobile phase composition, thus assessing the critical analytical attributes (retention time, tailing factor, and number of theoretical plates) as the constraints of method robustness. The proposed technique was optimized with a C18 (150 × 4.6 mm, 5 µm) column and 0.1% orthophosphoric acid buffer–acetonitrile (50:50, v/v) as the mobile phase at a flow rate of 1 mL/min using diode-array detector (230 nm) eluted favipiravir at 2.3 min.

Results
The optimized method validated as per ICH guideline Q2 (R1) was found to be eco-friendly, simple, precise (RSD 0.0051–1.2%), accurate (99.86–100.22%), linear (25–150 µg/mL), rugged (RSD 0.70%), and robust (RSD 0.6–1.6%) with a limit of detection and limit of quantitation of 1.140 µg/mL and 4.424 µg/mL, respectively.

Conclusion
Forced degradation studies (acidic, alkaline, thermal, photolytic, and oxidative conditions) revealed the suitability of the AQbD method for the analysis of favipiravir in tablet formulation.The developed and validated AQbD method is less time consuming and can be used in the industry for routine quality control/analysis of bulk drug and marketed Favipiravir products.

Highlights
A robust Design of Experiment enhanced stability-indicating analytical method was developed and validated for the estimation of favipiravir. Furthermore, the contemporary method would aid in extending the analysis of favipiravir in other formulations.
(025) Compliance with GMC Guidelines for the Use of a Chaperone in Urology Outpatient Clinic
Authors: Desouky E , Ibrahim M , Jallad S , Kalsi J 
Published: February 2024

Abstract

Introduction
Intimate physical examination is an integral part of our urological practice. There is a paucity of literature regarding the use of chaperones among urologists. As per GMC guidelines: The offer, and use, of a chaperone, including their full name and designation, should be clearly documented in patients’ notes.

Objective
Given the importance of this ethical topic for both patient safety as well as in providing support for the urologist, we decided to assess our performance as per the GMC guidelines for good medical practice.

Methods
We completed an audit loop to evaluate the performance of 12 members in our urology team as regards compliance with GMC guidance for the documentation of chaperone use in urology clinic. Based on our scoring system, we objectively assessed both overall team performance as well as individual scores for documenting chaperone use. • For each urologist, We checked records for 10 patients who attended urology clinic AND had a physical examination as evidenced in the notes and/or clinic letter •N= 120 patient records checked • Each urologist was given a score; NO mention of a chaperone= 0 point A chaperone JUST mentioned= 1 point The chaperone specified (name/signature)= 2 points

Results
Initial audit revealed overall chaperone documentation in clinical notes was 75.25% which may be acceptable while in the clinic letters, it was only 14.6%. At individual level, results were quiet variable reflecting the actual difference in practice between individuals in real life. Following the discussion of the 1st audit results in the urology clinical governance meeting, posters were made to raise awareness of the audit outcome as well as direct discussions with the urology team members to encourage them to improve their score. Six months later, re-audit showed significant improvement was achieved for individual as well as overall documentation to 85% of clinical notes and more than 50% of clinic letters.

Conclusions
Documenting chaperone presence during patient examination in urology clinics, is mandatory given the intimate nature of urological examination. We present the first report using a scoring system for objective assessment of a pertinent topic such as the use of chaperone and its documentation. This managed to achieve a significant improvement in our practice in accordance with GMC guidance for Good Medical Practice.

Disclosure
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(042) Reasons For and Time to Failure Associated with Inflatable Penile Prosthetics: A Multi-Center, High, Volume Experience
Authors: Griggs R , Stuart A , Henry G , Karpman E 
Published: February 2024

Abstract

Introduction
Despite technological advancements in the composition material, pump design, and infection retardant coatings, inflatable penile prosthetics (IPPs) remain prone to mechanical failure due to pump malfunction and/or fluid loss.

Objective
We aim to distinguish IPP component failure etiologies at the time of device replacement and/or repair between the two most common manufacturers: American Medical Systems/Boston Scientific (BSCI) and Coloplast (CP).

Methods
We performed an IRB approved, retrospective chart review of two private, high volume IPP surgeon revision and virgin cases (CPT codes 54405, 54408 and 54410) from January 2018 to May 2023. Mechanical revision indications were stratified by manufacturer and component location (pump, tubing, cylinder, and reservoir). Non mechanical revision cases were excluded (planned upsizing, patient dissatisfaction, herniation without replacement, impending erosion/eroded, crossover, and infection). Other exclusions included missing data (reason for failure, device type, op note, patient specific data, and/or prior institution operative details).

Results
Between the two surgeons, we identified a total of 646 cases during the study period. 120 were revision IPP cases, 66 of which, met inclusion criteria (57 BSCI and 9 CP). Of the BSCI mechanical inflatable penile prosthetic failures, 24/57 (42%) were due to cylinder rupture, 5/57 (9%) were due to tubing leaks, 3/57 (5%) were associated with reservoir perforation, 5/57 (9%) were due to cylinder aneurysm, and 20/57 (35%) were due to pump failure. Coloplast device mechanical failure was predominantly due to tubing fracture 7/9 (77.8%) while reservoir rupture and cylinder aneurysm each were 1/9 (11.1%). Between manufacturers, cylinder rupture and pump failure were more common in BSCI devices (25/57 vs 0/9, p=0.036; CI 95%) and (21/57 vs 0/9, p=0.064; CI 90%). While tubing fracture was more common in CP devices (5/57 vs 7/9, p=0.002; CI 95%). Cylinder aneurysm and reservoir rupture did not significantly differ between manufacturers. Similarly, log rank analysis illustrates similar time to mechanical failure between BSCI and CP (median 48 vs 41months respectively, p=0.277; CI 95%).

Conclusions
BSCI and CP device time to failure appears to be similar; this was also shown in recent published literature. BSCI pump failure appears to be greater than the previously described rate of 2% during their recall period from 2018-2020 and they fail significantly more than CP devices. BSCI devices most commonly fail due to cylinder rupture then other component failure. CP devices fail most commonly due to tubing rupture and this adds to the prior published literature. Further, multi-center studies are needed to validate these findings.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific Consultant.
(104) Zzz’s and the Big O: Investigating the Impact of Orgasm on Sleep Quality in Women
Authors: Yarborough C , Codrington J , Muthigi A , White J , Ramasamy R 
Published: February 2024

Abstract

Introduction
Sleep quality and sexual satisfaction are contributors to overall well-being, yet little research has investigated the impact of orgasms on subsequent sleep quality in women. This study aims to address this gap by analyzing sleep data from the Fitbit Versa 3 and self-reported sexual encounters to determine if sleep quality improves following orgasm. This data can contribute to an overall understanding of the connection between sexual experiences and sleep quality and strategies to improve overall health.

Objective
The primary objective of this study was to investigate whether sleep quality following a sexual encounter with orgasm improves sleep in women using sleep data collected from the Fitbit Versa 3 and self-reported sexual encounters.

Methods
Sexually healthy women, aged 18 and above, wore Fitbit Versa 3 devices for a duration of 6 weeks. The participants transmitted encrypted and de-identified data through the Fitbit app, ensuring privacy and confidentiality. Weekly online surveys were conducted to record the number, timing, and type of sexual encounters reported by the participants as well as if orgasm was achieved. During sexual encounters, the Fitbit devices measured heart rate, which was normalized to the participants' resting heart rate. Additionally, sleep data including proprietary sleep efficiency scores from the Fitbit devices were collected over the entire study period. Orgasm was self-reported by participants after every sexual encounter.

Results
A total of 17 sexual encounters were documented within six weeks. 14 representative encounters with full sleep data from the night before, and sleep directly after orgasm were included. For all sexual encounters, sleep data from the Fitbit device for the corresponding night and the previous night were examined. Linear regression analysis was conducted to evaluate any changes in sleep quality during this period. The results revealed a positive trend between improvements in minutes slept (a 54% increase in minutes slept among women with orgasm compared to women without orgasm, R-squared = 0.2434, p = 0.073) as defined by Fitbit with orgasm compared to the night before, respectively.

Conclusions
The findings of this study suggest a positive correlation between orgasms and improvements in sleep quality, as indicated by increased minutes slept and enhanced sleep efficiency. These results contribute to our understanding of the potential benefits of sexual activity on subsequent sleep. Further research with a larger sample size and controlled variables is warranted to validate and expand upon these findings. These initial findings highlight the potential role of orgasms in promoting better sleep quality, underscoring the importance of considering sexual experiences in the context of overall sleep health.

Disclosure
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(116) Breaking the Silence: Should I Be Concerned About Penile Fracture when Injecting Collagenase Clostridium Histolyticum?
Authors: Miller J , Hammad M , Loeb C , Azad B , Jenkins L , Yafi F 
Published: February 2024

Abstract

Introduction
Collagenase clostridium histolyticum (CCH) was first approved by the FDA in December 2013 for the nonsurgical management of Peyronie’s disease (PD) in men who are otherwise healthy. Penile fracture (PF) is a rare but concerning adverse event with known association with CCH administration.

Objective
To determine the risk of PF in men with PD who are receiving CCH and correlations between the risk of PF and comorbidities previously excluded in studies investigating the safety of CCH, namely the IMPRESS trial.

Methods
The TriNetX database was used to measure the rate of hospital visits for penile fracture using the ICD-10 code S39.840A. Results were limited to patients who were diagnosed with PD (ICD-10 N48.9) and were seen between July 2013 to July 2023. Patients were excluded if they had a history of surgical intervention for PD, including plaque excision and grafting, penile plication, and insertion of inflatable penile prosthesis. An odds ratio (OR) was calculated to compare the rates of PF between patients who had and had not received CCH. For those who received CCH, OR’s were calculated to determine if the presence of certain comorbidities increased the risk of PF.

Results
Within the examined time period, 44,542 patients with PD experienced 280 PF’s. The rate of PF in those who had and had not received CCH were 1.25% (N = 37) and 0.59% (N = 243) respectively, OR 2.122 (95% CI: 1.499-3.001, p&lt;0.0001). Tobacco use, diabetes mellitus, peripheral vascular disease, hypertension, hyperlipidemia, erectile dysfunction, and hypogonadism were not associated with an increased risk of PF in men receiving CCH (p&gt;0.05) (Table 1).

Conclusions
While the rate of PF following CCH use for PD was low at 1.25%, this was significantly higher than in those who did not receive CCH. Despite this, men who were previously excluded from studies examining the safety of CCH use for PD due to comorbidity burden were without an increased rate of PF, suggesting that these men may be able to receive CCH without additional risk of PF.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: Antares Pharma, Clarus Therapeutics, Coloplast.
(201) The Need for Enhanced Wellness Among Male Resident Physicians: A Critical Look at Participation Rates
Authors: Krishingner G , Mallory C , Moy L , Campbell K 
Published: February 2024

Abstract

Introduction
The demanding nature of medical residency-characterized by long working hours, irregular sleep schedules, and high-stress environments-poses significant health risks to resident physicians. These challenging work environments often interfere with resident’s ability to seek healthcare and wellness opportunities. This is further compounded in males who, studies suggest, are less likely to visit a doctor than their female counterparts. While numerous studies have explored specific health concerns such as resident burnout and depression, there remains a pressing need to prioritize overall wellness in this vulnerable population.

Objective
Our study aims to evaluate the male resident physician response to health and wellness initiatives.

Methods
This is a prospective study to evaluate male physicians in medical training who elected to undergo wellness screening at our institution. Following approval by the Institutional Review Board, participants were contacted via e-mail regarding participation in men’s health screening. Baseline demographics were obtained including age, specialty, and post-graduation year (PGY). Participants were asked to complete the Androgen Deficiency in the Aging Male (ADAM) and 36-Item Short Form Health Survey (SF-36) questionnaires in additional to obtaining lab work: BMP, CBC, Lipid panel, thyroid panel, testosterone, FSH, LSH, and estradiol. Survey questionnaire data was obtained through Research Electronic Data Capture (RedCAP).

Results
Out of 651 male residents and fellows, only 27 residents expressed interest in participation (response rate 4.1%). Of those, 66.7% (18/27) completed the surveys, and a mere 33.3% (6/18) completed the lab tests. While physical parameters scored highly (Table 1), role limitations due to emotional problems and energy/fatigue raised significant concerns with median scores of 50% and 47.5%, respectively. Similarly, perceived health change was stagnant with a median score of 50%. General health perception was middling at 62.5% whereas emotional well-being (72%) and social functioning (68.8%) were comparatively better, but not reaching optimal levels.

Conclusions
The low participation in voluntary health screenings among male resident physicians underscores a pressing need for enhanced wellness programs tailored to this group. It is vital for medical institutions to address barriers to participation and create a culture that prioritizes the health and wellbeing of its residents. These efforts may lead to better detection and management of health issues, improved overall wellness, and a more positive experience during the demanding period of residency.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: Tolmar pharmaceuticals.
(216) Efficacy of Novel Hyaluronic Acid Dermal Filler Injections for Penile Girth Enhancement
Authors: Carey B , Baylor A , Pearlman A , Gumpf K , Moore W , Clavell J , Kansal J , Milhouse F , Tatem A 
Published: February 2024

Abstract

Introduction
There has been renewed public and professional interest in the topic of cosmetic penile girth enhancement. Hyaluronic acid (HA) injections have been proposed as a safer alternative to surgical options, however limited data exist regarding efficacy.

Objective
The purpose of our study was to evaluate average girth changes and related metrics in men undergoing penile girth enhancement with sequential administration of HA dermal filler at a single site.

Methods
We performed a retrospective review of men who underwent penile girth enhancement with HA from May 17, 2022 to April 28, 2023.

Results
155 men underwent penile girth enhancement with HA filler and were instructed to follow a strict post-injection protocol. On average, men experienced a 0.633 cm increase in girth per treatment receiving an average of 12.5 total syringes over 2.2 treatments. Ultimately, all men receiving multiple treatments experienced an average girth increase of 1.8 cm as measured prior to their final treatment. 23 men who received 4 treatments or more experienced an average girth increase of 2.952 cm as measured prior to their final treatment. Of the 155 men treated, 19 (12.3%) required cosmetic correction with either hyaluronidase or abobotulinumtoxinA.

Conclusions
Our study suggests that injection of HA dermal filler is an effective option for men desiring non-surgical penile girth enhancement. Further studies are needed to better characterize outcomes and optimal treatment protocols.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: PhalloFill.
(278) Peyronie's Disease Among Men Who Have Sex With Men: Perceptions, Characteristics, and Psychosocial factors
Authors: Paulsen O , Louters M , Good J , Pereira TA , Bernie H 
Published: February 2024

Abstract

Introduction
Peyronie’s Disease (PD) is a condition characterized by the development of fibrous scar tissue causing penile curvature and often painful erections. From a sexual health perspective, PD is commonly researched in heterosexual men; however, there is a paucity of data assessing the impact that PD has on men who have sex with men (MSM) population.

Objective
This prospective survey study sought to collect data on how PD affects MSM from a biopsychosocial and sexual perspective and compare this population’s experience with non-MSM.

Methods
An anonymous online survey was deemed IRB exempt and administered to the following online platforms: Reddit to include r/PeyroniesSupport, r/lgbtstudies, r/sex, and on Facebook to the Peyronie’s Disease Support group in July 2023. Participants were asked demographic info, sexual orientation, type of sexual intercourse, family history of PD, history of trauma, immune disease, PD symptoms, partner and self-bother, degree of curvature, care seeking, medical interventions, impact on mental health, disease progression, as well as the Peyronie’s Disease Questionnaire (PDQ) survey. Descriptive statistics were performed.

Results
Thirty-six men completed the survey, nine being MSM (11.8% “men and others” and 14.7% “strictly men"). Reported sexual interactions included anal (50%), vaginal (77%), and oral (79%) intercourse. History of penile trauma occurred in 32% of respondents. None of the respondents reported a family history of PD, and two subjects disclosed autoimmune diseases. The most common symptoms, experienced by 91% of subjects, were “shortening and/or narrowing of the penis,” followed by: erectile dysfunction (69%), difficulty with sexual intercourse (44%), painful erections (31%), and painful sexual intercourse or masturbation (28%). 85% of surveyed men and 100% of MSM stated PD negatively impacts their mental health. Assessment of partner satisfaction revealed women express greater disapproval (12%) compared to men (3%). The majority of men (91%) reported seeing a urologist with only 35% seeing one regularly and 50% being MSM. A negative experience with a urologist was reported in 40% of MSM and 20% of non-MSM. Degrees of reported curvature were: 77% with less than or equal to 45 degrees, 6% between 46-60 degrees, and 18% between 61-90 degrees. Greater than 60% and 27% were offered medical and surgical interventions, respectfully. 62% reported their PD has remained stable.

Conclusions
In conclusion, the results of this survey suggest that PD may have a greater negative effect on mental health and experience with a urologist for MSM. However, non-MSM are more likely to experience partner disapproval. Overall, the characteristics of PD do not grossly vary between MSM and non-MSM but the psychosocial aspect may possess greater consequences for MSM. More data is needed on this understudied population affected by PD.

Disclosure
No.
(284) A Preliminary Investigation on the Incidence of Complications and Patient Contentment Following the Surgical Implantation of Inflatable Penile Prosthesis After Salvage Radical Prostatectomy
Authors: Khalaf Alla K , El-Achkar A , Mehr J , Wang R 
Published: February 2024

Abstract

Introduction
Erectile dysfunction (ED) is a common complication post salvage radical prostatectomy (RP). Yet, there is scant data in the literature on complication rates and patient satisfaction in those that undergo inflatable penile prosthesis (IPP) insertion post salvage radical prostatectomy (RP) following targeted radiotherapy for treatment of localized prostate cancer. It is understood that these patients have a higher rate of complications as they have experienced both radiation and prostatectomy adverse events which could alter their overall satisfaction after prosthetic surgeries.

Objective
Our aim is to conduct a preliminary analysis of IPP complication rates and satisfaction rate in patients that had 3-piece IPP implantation following salvage radical prostatectomy.

Methods
A retrospective chart review from our institutional database was done from 2018 to 2021. The inclusion criteria were patients that had an inserted 3-piece IPP and a history of salvage RP following radiation therapy. Only patients that participated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire at least 6 months from implant date were included. Data on satisfaction, IPP infection rates, mechanical failure rates, and overall complications was also collected. Complications include hematoma, erosion, reservoir hernia.

Results
A total of 22 patients were included in the study. The median age (IQR) is 65 (64-67) years and the median time (IQR) from RP to IPP insertion is 23 (11-49) months. All patients were approached in a penoscrotal manner with submuscular placement of reservoir (Table 1). The satisfaction rate was high at 91.8% on follow up. Overall complications rate was observed in 2 patients. One patient had a mechanical pump failure at 37.9 months while another patient had signs and symptoms of scrotal wall infection at 15 months. Both devices were easily replaced with no post op complication and remained functional on further follow up.

Conclusions
In patients that underwent salvage prostatectomy IPP insertion, they reported high satisfaction rates and low complication rates despite the exposure to both prostate cancer treatments adverse events. Further research is needed to confirm the results obtained and to investigate the underlying causes for the observed outcomes. The scientific process is iterative, and the answers obtained from one study often lead to more questions and the need for additional investigations.

Disclosure
No.