ED Treatment Research Articles

Experts’ views on the implementation of digital interventions for eating disorders: a Delphi study

BackgroundEating disorders (EDs) constitute a considerable burden for individuals and society, but adequate and timely professional treatment is rare. Evidence-based Digital Mental Health Interventions (DMHIs) have the potential both to reduce this treatment gap and to increase treatment effectiveness. However, their integration into routine care is lacking. Understanding practitioners’ attitudes towards DMHIs for EDs is crucial for their effective use.AimsTo investigate the consensus among German ED treatment experts on the relevance of different influencing factors for DMHI use in EDs.MethodsThis Delphi study consisted of two rounds and was conducted online with an initial sample of N = 24 ED experts (Mage=41.96, SDage=9.92, n = 22 female). Prior to the Delphi rounds, semi-structured qualitative telephone interviews were performed to explore participants’ attitudes, experiences, and expectations towards DMHIs. In order to construct the Delphi survey, content analysis was applied to a subset of ten interviews. A total of 63 influencing factors were identified and grouped into three main categories: contextual conditions, design, and content of DMHIs. In both Delphi rounds, the interview participants were subsequently invited to rate each of the factors with regard to their importance on 10-point scales. Group percentages and individual ratings of the first round (n = 23) were presented in the second round (n = 21). Consensus was calculated for each item (defined as IQR ≤ 2).ResultsImportance ratings were high across items (M = 7.88, SD = 2.07, Mdn = 8). In the first round, 48% of the items reached consensus, with its most important (Mdn = 10) factors referring to data security, evidence base, technical requirements, usability, and specific DMHI content (psychoeducation, crisis intervention). In the second Delphi round, a consensus was reached on 73% of the items. No consensus was reached on 17 items.ConclusionsThe findings on practitioners’ attitudes and priorities have relevant implications for subsequent DMHI development, dissemination, and implementation strategies, indicating that the highest-rated factors should be highlighted in the process.

Association of Emergency Department Length of Stay and Hospital Mortality in Patients Under Investigation for COVID-19.

We aimed to determine the association between hospital mortality of patients under investigation (PUI) for COVID-19 and emergency department length of stay (EDLOS). A retrospective study was conducted from April 3, 2020 to April 2,2022. Adult PUI who presented with both clinical and epidemiological risk factors for COVID-19 disease and underwent sample collection with nasal swab for reverse transcription polymerase chain reaction were included in the study. The factors associated with EDLOS and hospital mortality were investigated using univariate logistic regression and multivariate logistic regression analyses. A total of 961 PUI were enrolled that included 836 (87%) non-COVID-19 patients. The median (interquartile range [IQR]) EDLOS durations for 7-day and 30-day mortality of all PUI were 3.1hours (2.1,4.3, P = 0.231) and 3.2hours (2.1,4.3, P = 0.653). Multivariate logistic regression analysis revealed that the significant factors associated with EDLOS longer than 4hours were consultation of three departments (adjusted odds ratio (aOR) 27.3, 95% CI 2.42-309.71, P = 0.007), emergency severity index (ESI) level 3 (aOR 2.31, 95% CI 1.37-3.9), investigations >2 (aOR 2.62, 95% CI 1.62-4.25), nebulization (aOR 2.34, 95% CI 1.39-3.96), administration of intravenous fluid (aOR 2.62, 95% CI 1.59-4.33), performing ≥1 procedure (aOR 3.35, 95% CI 1.51-7.43), and discharged patients (aOR 2.13, 95% CI 1.02-4.48). The significant factors associated with prolonged EDLOS in PUI included consultation of three departments, ESI level 3, investigations >2, ED treatment, ED procedures, and discharged patients. The median times of EDLOS and hospital LOS were 3.2hours and 5.7 days. The EDLOS had no significant association with short-term mortality.

High prevalence of erectile dysfunction in male patients with acute stroke was associated with age but not to modifiable cardiovascular risk factors

BackgroundErectile dysfunction (ED) and stroke share common risk factors, and symptoms of ED often precede the development of clinical cardiovascular disease (CVD). However, little is known about how ED is...

Effectiveness of a blended group transdiagnostic treatment for emotional disorders: Study protocol for a randomized controlled trial

IntroductionEmotional disorders (ED) (mood and anxiety disorders) are very prevalent and disabling, and often appear in comorbid presentations. Although there are effective treatments for these disorders, there is still a large gap between the number of people who need them and those who actually receive them. The combination of three strategies may help in this regard, facilitating the dissemination and accessibility of treatment: the transdiagnostic perspective of ED, the group format, and the use of technologies in a blended format (i.e., the combination of online and face-to-face therapy elements). This study intends to compare the efficacy of a new ED intervention, a transdiagnostic group treatment protocol administered in a blended format, with that of a face-to-face treatment. This article describes the study protocol for the randomized controlled trial. Method and analysesA two-arm, parallel-group, randomized controlled clinical trial (RCT) will be conducted. Participants (N = 144) will be adult volunteers suffering from DSM-5 anxiety and/or depressive disorders and will be randomly assigned to one of two conditions: Face-to-face Group Transdiagnostic Protocol or Blended Group Transdiagnostic Protocol. The face-to-face condition will consist of a total of 16 weekly face-to-face group sessions, while the blended condition will consist of 8 biweekly face-to-face group sessions in combination with self-applied work through a web platform. Clinical and acceptability measures will be included in both groups. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-, 6- and 12-month follow-ups. This study received the approval of the Ethics Committee of Universitat Jaume I in October 2021 (CD/91/2021). Intention-to-treat analyses will be performed. Statistical analyses will be carried out using SPSS version 28.0. The results will be reported in accordance with CONSORT recommendations. DiscussionThis is the first RCT to compare the effectiveness of an ED treatment protocol based on the transdiagnostic perspective and applied in group and blended format. It will offer relevant data to continue moving forward towards treatment alternatives that are cost-effective and more accessible, so that all patients with ED who require them can benefit. Trial registrationClinicalTrials.gov Identifier: NCT05569018. Registered 06 October 2022, https://clinicaltrials.gov/study/NCT05569018

Renal Transplantation Enhances the Sildenafil Citrate Effectiveness in Patients with Erectile Dysfunction. A Single-Center Perspective

ObjectiveTo assess the efficacy and safety of Sildenafil citrate in the treatment of ED in (HD) compared to post-RT patients. Patients and methodsA concurrent cohort prospective study to evaluate the efficacy of Sildenafil in the treatment of ED in 24 HD patients (Group A) and 13 patients with persistent ED one-year post-RT (Group B). The initial dose of Sildenafil was 25 mg, increased to 50 mg if there is an adequate response. An Arabic-translated International Index of Erectile Function (IIEF) questionnaire was completed one week before and after Sildenafil treatment. An IIEF erectile function score of 26 or an improvement of at least 10 points for the total IIEF score was considered a favorable response to Sildenafil. ResultsGroup A included 22 patients with a mean age of 47.32 ± 7.013 years, whereas Group B included 13 patients with a mean age of 56.87 ± 9.612 years. The overall efficacy rate of Sildenafil was 40.9% and 76.9% in groups A and B, respectively. The post-treatment IIEF5-15 score increased from 11.1 ± 5.99 to 12.5 ± 6.41 (p = .458) and from 11.82 ± 7.534 to 21.91 ± 5.700 (p = .002) in groups A and B, respectively. In both groups, the duration of HD had no impact on ED improvement except in the post-RT non-responder subgroup. Hypertension, gastrointestinal symptoms, and flushing were both groups' most common side effects. ConclusionRT could enhance the response to sildenafil in treating patients with ED. The outcome is better in younger post-RT patients with moderate and severe erectile dysfunction and shorter dialysis duration.

Extraction of phosphorus from sewage sludge ash by electrodialysis combined with wet-chemical extraction

ABSTRACT Phosphorus (P) recovery from sewage sludge ash (SSA) is considered to be an effective method for P recovery. In this work, P extraction and the removal of heavy metals were realized by electrodialysis. Low-cost, easily available, and environmentally friendly plant extracts were applied as suspension to reduce the inevitable secondary pollution. And the feasibility of using plant extracts was analysed by comparing with using deionized water (DI) and oxalic acid (OA) solution. When SSA was suspended in different solutions (DI, OA, and three plant extracts – Hovenia acerba (HA), Saponin (SA) and Portulaca oleracea (PO)), the effects of reaction time and plant extract concentration on P extraction and heavy metal separation of SSA under ED treatment were compared. After the process of electrodialysis, compared to other experimental groups, electrodialysis with plant extracts obtained more P released from SSA, but less P migrated to the anode chamber. However, when SSA was suspended in PO at a concentration of 80 g/L, the proportion of P transferred from SSA to the anode chamber can still reached 37.86%. In addition, the use of plant extracts as suspension had a positive effect on the removal of heavy metals, but its effect was lower than that of the oxalic acid-treated experimental group. The results indicated that the use of plant extracts for wet-chemical extraction combined with electrodialysis promoted the removal of heavy metals and the extraction of P from SSA, which is a feasible option.

What are the incidence and costs associated with interfacility emergency department transfer patients treated by oral and maxillofacial surgeons?

ObjectiveInterfacility emergency department transfers (IET) for maxillofacial trauma and infections are prevalent in the US, with significant implications for healthcare costs. Limited availability of oral and maxillofacial surgeons (OMS) exacerbates unnecessary transfers and associated expenses. This study aimed to determine the incidence and costs of OMS IET. Study designA retrospective cohort study was performed for maxillofacial trauma and infection IET at the University of Illinois Health main hospital via electronic medical record query for terms “infection [or] trauma [and] transfer”. Inclusion criteria required presentation 01/01/22 to 06/30/22; ED-ED transfer; consultation by OMS. Distance transferred, insurance type, location of treatment, weekend presentation, and associated costs were collected. Results1,099 records were identified, including 46 trauma IET and 122 infection IET. Costs ranged from $2,683,918.90 to $7,984,912.89, indicating ∼$1.5 billion annual expenditure across US OMS programs. Three trauma IET required urgent treatment; no infection IET were "emergent." Trauma IET averaged 20.7+17.1 miles and infection IET 22.0+17.4 miles for transfer distance. Among trauma IET, 28 were treated in the OR, 10 had outpatient follow-up, and 8 ED treatment. Among infection IET, 57 received ED treatment, 56 OR treatment, and 9 received antibiotics/no treatment. ConclusionsMaxillofacial trauma and infection IET impose significant healthcare costs. Increased funding for OMS training may mitigate the shortage and improve patient care. Further research is needed for better triaging and reimbursement strategies.

From guided self-help to comprehensive ED treatment

IntroductionThe incidence of eating disorders is increasing in Hungary and Central-Eastern Europe. The number of complex/severe cases is also increasing. Accordingly, several new unmet needs of the users and their relatives appear in the clinical care.ObjectivesAs a possible response to these unmet needs, we have introduced a multifaceted care model for eating disorders. To facilitate easily accessible yet effective care close to home, a support programme with an online guided self-help tool and regular consultations with first responder psychiatrists or clinical psychologists has been introduced. For non (or partial) responders, a multi-faceted modular treatment programme has been developed with an individualised combination of different therapeutic approaches, including family therapy, dialectical behaviour therapy (DBT) specific to binge eating disorder and bulimia, CBT and the use of virtual reality as an adjunct treatment. The most severe cases are referred for (also multifaceted) inpatient treatment. In terms of research, we want to focus on the key issues for rapid, cost-effective treatment. Firstly, we want to develop an individual profiling system at the start of therapy to assess which individual combination of modules can produce a rapid therapeutic response. Secondly, we want to identify the active gamechanger elements of therapy that are associated with the greatest change in symptoms.MethodsPatients complete the following questionnaires:-in the guided self-help group: Eating disoreder inventory, (EDI-I), McMaster Family Assessment Device (FAD), Eastin Disorder Diagnostic Scale (EDDS), Eating Behavioral Severity Scale, Eating Disorders Symptom Impact Scale (EDSIS-S)- in DBT groups: Eating Disorder Examination Questionnarie (EDE-Q), Three Factor Eating Questionnaire-R21, Rosenberg Self-Esteem Scale, Patient Health Questionnaire-(PHQ-9), Cognitive Emotion Regulation Questionnaire (CERQ)- in individual therapies: Mini International Neuropsychiatric Interview (MINI) and Structured Clinical Interview for DSM 5- Alternative Model for Personality Disorders (SCIP-5-AMPD), EDI-I., Mentalization Questionnaire (MZQ), Dissociation Questionnaire (DIS-Q), Symptom Checklist-90 (SCL-90), (PHQ-9), Childhood Trauma Questionnaire (CTQ) and Young Parenting Inventory (YPI).ResultsPatient recruitment and therapies are currently underway, the first preliminary results are expected in the spring period.ConclusionsIn order to provide individualized care more effectively, it is important to identify the factors that determine which therapeutic modalities work best for the patient.Disclosure of InterestNone Declared

Value of phosphodiesterase 5 inhibitors as a combination therapy for treating erectile dysfunction: A literature review

AbstractErectile dysfunction (ED) is increasing in prevalence, with estimates that 50% of men between 40 and 70 years of age suffer from the disease. Due to a wide array of available medical interventions, significant focus has been put on combination therapies that can treat ED refractory to first‐line treatments such as phosphodiesterase 5 inhibitors (PDE5is). However, reviews evaluating monotherapy noninferiority and patient satisfaction of monotherapy versus combination therapy are lacking. A thorough PubMed search was performed to evaluate combination therapy in ED treatment. Articles published between January 2008 and June 2023 were reviewed, including randomized control trials, retrospective analyses, and cohort studies. Combination therapies included PDE5i plus another PDE5i, testosterone supplementation, α‐blockers, vacuum erectile devices, intracavernosal injections, and low‐intensity shockwave therapy. Based on this review, PDE5i monotherapy is not inferior to combination therapy and has increased satisfaction, convenience, and ease of use for patients with ED. Limitations of current literature on combination therapy include small sample size, limited data on patient satisfaction, possible biases, and limited follow‐up time. Further studies will need larger randomized control trials with follow‐up times greater than 1 year.

Enterococcus durans 98D alters gut microbial composition and function to improve DSS-induced colitis in mice

Enterococcus durans, is a potential functional strain with the capacity to regulate intestinal health and ameliorate colonic inflammation. However, the strain requires further investigation regarding its safety profile and potential mechanisms of colitis improvement. In this study, the safety of E. durans 98D (Ed) as a potential probiotic was studied using in vitro methods. Additionally, a dextran sulfate sodium (DSS)-induced murine colitis model was employed to investigate its impact on the intestinal microbiota and colitis. In vitro antimicrobial assays revealed Ed sensitivity to common antibiotics and its inhibitory effect on the growth of Escherichia coli O157, Streptococcus pneumoniae CCUG 37328, and Staphylococcus aureus ATCC 25923. To elucidate the functional properties of Ed, 24 weight-matched 6-week-old female C57BL/6J mice were randomly divided into three groups (n = 8): NC group, Con group (DSS), and Ed group (DSS + Ed). Ed administration demonstrated a protective effect on colitis mice, as evidenced by improvements in body weight, colonic length, reduced disease activity index, histological scores, diminished splenomegaly, and decreased goblet cell loss. Furthermore, Ed downregulated the expression of the pro-inflammatory cytokine genes (IL-6, IL-1β, and TNF-α) and upregulated the expression of the anti-inflammatory cytokine gene IL-10. The 16S rRNA gene sequencing revealed significant alterations in microbial α-diversity, with principal coordinate analysis indicating distinct differences in microbial composition among the three groups. At the phylum level, the relative abundance of Actinomycetota significantly increased in the Ed-treated group. At the genus level, Ed treatment markedly elevated the relative abundance of Paraprevotella, Rikenellaceae_RC9, and Odoribacter in DSS-induced colitis mice. In conclusion, Ed exhibits potential as a safe and effective therapeutic agent for DSS-induced colitis by reshaping the colonic microbiota.

(161) Is there a Difference in Inflatable Penile Prosthesis Mechanical Failure and Infections Rates in Relation to Prostate Cancer Treatment Modality (Radiation Therapy vs Radical Prostatectomy)

Abstract Introduction Inflatable Penile Prosthesis (IPP) implantation as a treatment for ED has high satisfaction rates in the general population; however, there is limited literature on quantification of complication rates as stratified by ED etiology. Objective Our aim was to compare mechanical failure and infection rates in patients undergoing IPP implantation for ED following Radical Prostatectomy (RP) versus radiation therapy (RT) for prostate cancer. Methods A retrospective chart review from our institutional database was conducted to identify 405 patients who underwent IPP placement at our institution from 2015–2019, then selecting for those whose etiology of ED was following RP or RT. To prevent crossover confounding; patients with history of pelvic radiation or salvage radiotherapy were excluded from the RP group and patients with history of RP were excluded from the RT group. Data was obtained from 75 patients who met criteria for inclusion: 44 patients in the RP group and 31 patients in the RT group. Mechanical failure, infection rates, mean EDITS scores and additional survey questions were compared between the radiation and RP groups. Results Patient demographic information and IPP complication and satisfaction rates are listed below in Table 1 and Figure 1. There was a statistically significant difference in number of patients experiencing IPP complications, 19.4% (n=6) of patients in the RT cohort and 4.5% (n=2) in the RP cohort, respectively. There was no statistically significant difference found in stratified complications- infection rates, device erosion rates, mechanical failure rates, or device removal and/or replacement rates between the two groups. The RP cohort had a significantly higher mean Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire score versus the RT cohort, 91.58 to 76.02, respectively. Conclusions These preliminary findings, while requiring large-scale follow up, suggest that there is a higher rate of IPP related complications in patients with device placement following RT for prostate cancer versus RP. Disclosure No.

(144) The Use of Virtual Reality Systematic Desensitization for the Treatment of Psychogenic Erectile Dysfunction: A Pilot Study

Abstract Introduction Erectile dysfunction (ED) is a sexual dysfunction that affects the sexual health of millions of men around the world. In recent years, the evidence indicates an increase in cases of ED among individuals under 40 years old. In most cases, the etiology is of psychogenic origin. Cognitive-behavioral therapy (CBT) has been proven effective and remains one of the most widely used treatments for ED in these cases although controlled studies are lacking. One of the most effective CBT techniques is a set of activities performed by a couple, known as systematic desensitization (SD). SD involves gradually exposing the patient to feared intimacy-related activities with their partner. However, many patients do not have a stable partner or do not want their partner to participate in the treatment. Technological advances are helping to create virtual SD programs which are able to reproduce the sights, sounds, and other sensations of the feared situation. Objective Our goal is to determine the potential usefulness of a new virtual reality-based SD program for the treatment of psychogenic ED (pED). Methods Six sexually active men diagnosed with pED based on criteria for Erectile Disorder from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) completed virtual SD over 8 weeks. The program consisted of one educational session and five different virtual reality audio exercises which were completed at home using a masturbation aid device called Myhixel ED01, that is connected to a smartphone. The five-item Spanish version of the International Index of Erectile Function (IIEF-5) questionnaire was used to assess symptoms before and after the treatment and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire was used for evaluating satisfaction with treatment. Results Patients enrolled had a mean age of 34.83 years (range 27–39) and experienced an improvement in erectile function, mean IIEF-5 score pretreatment was 11(range 9–13) mean posttreatment IIEF score was 18 (range 14–21). The mean EDITS index score at the end of the treatment was 64.70 (range 59–70.25). No adverse effects were reported during the treatment. Conclusions This case series suggests that the use of a virtual reality-based SD could be a potentially effective and safe therapeutic option for men with pED. This new treatment would facilitate greater access of men with pED to one of the most commonly used strategies of sexual therapy, as it would no longer require the participation of a partner. Studies with adequate sample sizes, control groups, randomization, and follow-up are needed to determine the effectiveness of this new treatment. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: NEW WELLNESS CONCEPT SL.

(206) Strategies of Nitric Oxide Augmentation for PDE5 Inhibitors

Abstract Introduction Erectile function and endothelial functions are closely related entities. Nitric oxide NO regulates circulation and microcirculation involved in erection.NO concentration is reduced with aging, diabetes, environment pollution smoking, obesity, inflammation, high prolactin, low testosterone oxidative stress and atherosclerosis. Many of erectile dysfunction patients are PDE5 inhibitor resistant. Strategies to enhance NO expression, can be employed to convert treatment resistant patient into responder. Objective Employ every possible mechanism to augment nitric oxide expression. Greater base line nitric oxide better would be PDE5 inhibitor respose. Methods Internet search was made on various website including pub med, science direct, google scholars using key words like erection, erectile dysfunction, nitric oxide, l arginine, oxidative stress, antioxidant, NOS, endothelial dysfunction, atherosclerosis and etc. This was followed by literature study on given topic. Results Efficacy of PDE 5 inhibitor in ED treatment is 70%. NO concentration decline to 50% by age of 40 and is only 15% at age 60. Humming can increase nasal NO level up to 15 time. Conclusions NO regulates endothelial function, vasodilatation, platelet aggregation inhibition, free radical scavenging, testosterone synthesis and neuronal protection. Study of mechanism of NO production provides, strategies for its enhancement. L arginine, L citrulline, serve as substrate and vitamin C, tetrahydrobiopterin (BH4) act as co factors in production of NO. Endothelial nitric oxide synthase e NOS, neuronal nitric oxide synthase n NOS are major enzymes act involved in synthesis. Oxygen is required for NO synthesis process. Supplementation of substrate and cofactors help increase NO levels. Oxygen availability can be increased through exercise and raising hemoglobin level. Reactive oxygen species ROS convert NO into bioinactive peroxynitrite which itself is ROS. Oxidative stress can cause endothelial nitric oxide synthase uncoupling. Consequently eNOS start producing ROS. This causes oxidation of NOS and as well as of cofactor like BH4 and vitamin C. ROS also increase level of methylarginines. Antioxidant used to neutralize ROS include Co Q10, alpha lipoic acid, flavonoids, bioflavonoids poly phenols, pycnogenol, resveterol, fulvic acid and etc. Second mechanism NO production is from dietary nitrates. Nutritional nitrates are converted into nitrite by oral anaerobic bacteria’s. Nitrate rich foods like beet root or spinach are added to enhance nitrate based NO. Nitric oxide thus produced is used for vasodilatation of penile vessels as well sinuses of corpus cavernousm. Apart from that it inhibits uncoupling of NOS. This support L arginine based mechanism of NO production. Nitroglycerin or minoxidal act as NO donors. These agents can be used locally at glans penis to augment NO availability. Bee breathing is maneuver in which humming sound vibrates nasal sinus increasing NO production up to 15 folds. Inhaled NO act as bronchodilator which increase lung capacity leading to higher blood oxygen concentration. Various NO enhancement strategies thus applied, may convert non responder PDE5 inhibitor to responders. Disclosure No.

(031) Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered With and Without Water versus Viagra Film-Coated Tablets in Healthy Adult Male Volunteers

Abstract Introduction Orodispersible film (ODF) formulation offers ease of use, convenience of administration, and other advantages, especially for patients who have difficulty in swallowing or are on liquid restriction compared with conventional oral formulations for the treatment of erectile dysfunction. Objective These studies compared the bioequivalence of 50 mg sildenafil citrate ODF formulation (test drug) with the marketed 50 mg sildenafil citrate film-coated tablet (FCT) (Viagra; Pfizer, New York, NY) (reference drug), with and without water in 2 randomized cross-over studies. Methods Two randomized cross-over studies were conducted. The first study explored the bioequivalence of test drug administered with and without water compared with the reference drug with water. The second study investigated the bioequivalence of test drug, without water, compared with the reference drug with water. 42 healthy adult male volunteers started the first study and only 40 completed. While 80 subjects who were enrolled completed the second study. All the 120 subjects from both the studies were included for pharmacokinetic and bioequivalence analysis. All volunteers fasted for 10 hours pre-dose. A 1-day washout period between doses was observed. Blood samples were collected at regular intervals both before (up to 120 minutes before dosing) and after dosing (at different intervals up to 14 hours) dosing stages. Statistical analyses on pharmacokinetic parameters were performed. Safety and tolerability for both the formulations were evaluated. Results In the first study, bioequivalence was demonstrated for sildenafil citrate ODF administered with water when compared with the Viagra FCT. The ratios of adjusted geometric means (90% confidence interval (CI)) were maximum plasma concentration: 1.02 (94.91–108.78) and area under the plasma concentration-time curve: 1.09 (104.49–113.21) for sildenafil citrate ODF administered with water vs Viagra FCT. These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. The pharmacokinetic parameters for the second study also demonstrated bioequivalence for sildenafil citrate ODF when administered without water compared with Viagra FCT. The ratios of adjusted geometric means (90% CI) were maximum plasma concentration: 1.02 (95.47–109.36) and area under the plasma concentration-time curve: 1.06 (103.42–108.40) for sildenafil citrate ODF administered without water vs Viagra FCT. Adverse events in both the studies occurred at similar rates for the 2 formulations and were mild in intensity and were expected from the known safety profile. Conclusions Sildenafil citrate ODF administered with and without water met bioequivalence criteria compared with Viagra FCT administered with water under fasted conditions in healthy adult male volunteers. These results suggest that the new ODF formulation can be used interchangeably with the marketed FCT formulation. Therefore, the new ODF formulation can be used as a suitable alternative to the conventional oral solid dosage form for the treatment of ED. Disclosure Yes, this is sponsored by industry/sponsor: Viatris Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Viatris Inc.

(117) Is Platelet-Rich Plasma Effective and Safe for Managing Erectile Dysfunction? A Meta-Analysis of Before-After Data from Clinical Studies

Abstract Introduction Erectile dysfunction (ED) is common health issues among men with increasing prevalence along with age. With the advancement of technology, the aim of therapy for ED is start to shift in reversing the pathology and not only relieving the symptoms. Platelet-rich plasma (PRP) are one of the regenerative modalities that has gained popularity in many medical disciplines. Many studies have been conducted that favour PRP in improving erectile function. However, no relevant meta-analysis of PRP have been performed to date. Objective A single-arm meta-analysis were conducted to evaluate the outcome of PRP for the treatment of ED based on the data before and after the procedures. Methods We systematically searched PubMed, Embase, Scopus in June 2023 to find the relevant articles based on the Preferred Reporting Items for Systematic Review and Meta-analysis statement. All randomized controlled trials (RCTs), observational, and case control studies in English with 10 or more subjects and a minimum of 1 month follow-up after PRP treatment reporting International Index of Erectile Function-Erectile Function (IIEF-EF) score were included. Pooled analysis on outcomes that were reported in at least 2 studies were performed using RevMan 5.4 and STATA18 with 95% confidence intervals (CIs). We also conduct heterogeneity test and a leave-one-out sensitivity analysis. Results A total of three RCTs, three observational studies and one case-control study, comprising 236 patients, were included from 183 studies identified. The pooled analysis showed that PRP injection significantly increased the IIEF-EF score by 3.87 (95% CI: 2.92, 4.83, p<0.00001), 3.01 (95% CI: 2.27, 3.74, p<0.0001), 3.29 (95% CI: 2.26, 4.32, p<0.00001), at 1, 3, and 6, months follow-up. Subgroup analysis of IIEF-EF based on the use of PDE5i in the protocol or during follow-up period also found the same finding result. The proportion of patient who met MCID after 6 months of follow of was 70% (95% CI: 59%, 80%). In term of penile hemodynamic, a significant improvement was found in peak systolic velocity and end diastolic velocity at the end-point of follow-up. On contrary, there was no significant improvement were found for IIEF score of intercourse satisfaction and overall satisfaction domain. The most common complication reported were transient subcutaneous bruising. Two cases reported a formation of painless plaque but no other major adverse events were reported. Consistent result was found after a leave-one-out sensitivity analysis. Conclusions PRP is a promising restorative modality for ED with improvement in IIEF-EF score and penile hemodynamic. However, further studies and human trials are required to confirm the efficacy and durability of this novel treatment as well as to find out the best protocol of administration. Disclosure No.

(028) Intracavernosal Injection of Platelet-Rich Plasma for the Treatment of Erectile Dysfunction: A Meta-Analysis of Randomized Placebo-Controlled Trials

Abstract Introduction Erectile dysfunction (ED) affects 3 to 76.5% of men globally. Appropriate treatments for ED patients are vital to ensure their quality of life. However, the present conservative ED treatments cannot reverse the underlying pathology and often lead to discontinuation due to the lack of efficacy. Regenerative therapies, including platelet-rich plasma (PRP), have been gaining increasing interest for the last few years. Preclinical studies suggest that growth factors in PRP may be beneficial in ED. With the increasing evidence of PRP, a meta-analysis has yet to be conducted to determine its efficacy and safety compared to a placebo. Objective To systematically evaluate PRP's efficacy and safety for treating ED based on randomized placebo-controlled trials (RCTs) results. Methods A comprehensive search on PubMed, Scopus, and EMBASE databases was conducted on June 2023 to find relevant articles following Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. RCTs in English evaluating PRP's efficacy and safety in treating ED were included. The primary outcomes were the International Index of Erectile Function-Erectile Function (IIEF-EF) score at 1-, 3-, and 6-months post-treatment. The secondary analysis includes the proportion of patients who met the minimal clinically important difference (MCID) of IIEF-EF score, IIEF score for sexual satisfaction and overall satisfaction, peak systolic velocity (PSV) in the cavernousal artery, and the complication rate after treatment. Quality of included studies was assessed using JADAD Score and Cochrane RoB2 tools. Meta-analysis with a random or fixed effects model based on the heterogeneity was performed using Revman 5.4. Results From 183 articles in initial research, three RCTs with low risk of bias were reviewed. We included 103 patients in the PRP group and 106 in the placebo group. The baseline of the evaluated score from both groups was comparable despite variable PRP protocol being used. The pooled analysis showed that PRP is associated with higher IIEF-EF scores at 1, 3, and 6 months follow up compared to placebo with a mean difference (MD) of 2.85 (95% CI, 1.68 – 4.03, p: <0.00001), 2.81 (95% CI, 1.57 – 4.05, p: <0.00001), 3.11 (95% CI, 1.96 – 4.27, p: <0.00001). Similarly, the proportion of patients who met MCID and PSV at follow-up also favoured the PRP group. On contrary, the IIEF score for sexual satisfaction and overall satisfaction domain, as well as VAS score post-injection were comparable between groups. No significant adverse event was reported in any study during follow-up. Conclusions The present meta-analysis suggests that PRP is effective and tolerable as a restorative therapy for managing ED patients compared to a placebo. Nevertheless, additional RCTs with more robust data from larger sample sizes and longer-term follow-ups are required to corroborate the findings. Disclosure No.

“Maze Out”: a study protocol for a randomised controlled trial using a mix methods approach exploring the potential and examining the effectiveness of a serious game in the treatment of eating disorders

BackgroundEating Disorders (ED) are severe and costly mental health disorders. The effects of existing treatment approaches are limited and there is a need to develop novel interventions, including digital strategies that can increase engagement and effectiveness. Maze Out is a new serious game coproduced by patients and ED therapists, which allows patients to “play” with the reality of an ED and reflect on associated challenges.ObjectivesThe present study has two main objectives: (1) to evaluate the effectiveness of adding Maze Out to treatment as usual (TAU) in a randomised controlled trial (RCT); and (2) to examine in depth the potential of Maze Out by examining how it is perceived and used in the context of an RCT.MethodsParticipants will be recruited from mental health care services, endocrinology departments or Community Centres offering treatment for ED. Patients suffering from ED (N = 94) will be randomised to either TAU or TAU plus Maze Out. Primary outcome will be measured in terms of changes in self-efficacy, measured by a 5-item self-efficacy questionnaire (5-item SE_ED). Secondary outcome measures will include feelings of ineffectiveness and self-image, as measured by Eating Disorder Inventory, version 3 (EDI-3), Brief INSPIRE-O and Structural Analysis of Social Behaviour Intrex Questionnaire (SAS-B). Data will be collected at baseline (enrolment in the study), and subsequently 8 and 15 weeks after inclusion. Experiences of playing Maze Out will be examined in a sub-sample of participants, utilising both quantitative user analytics and qualitative interview data of patients, interview data of significant others, and healthcare professionals to explore the possible impact of Maze Out on disorder insight, communication patterns between patients and therapists and understanding of their disorder.DiscussionTo our knowledge Maze Out is the first serious game coproduced by patients and therapists. It is a novel and theoretically grounded intervention that may significantly contribute to the healing process of ED. If found effective, the potential for wide-spread impact and scalability is considerable.Trial registration ClinicalTrials.gov NCT05621018.

Genetic association of lipid-lowering drug target genes with erectile dysfunction and male reproductive health.

The effect of hypolipidemic drugs on male erectile function is still controversial. This Mendelian randomization (MR) study aimed to explore the potential impact of lipid-lowering drug targets on ED. We collected seven genetic variants encoding lipid-lowering drug targets (LDLR, HMGCR, NPC1L1, PCSK9, APOB, APOC3 and LPL) from published genome-wide association study (GWAS) statistics, and performed drug target MR analysis. The risk of ED was defined as the primary outcome, sex hormone levels and other diseases as the secondary outcomes. Mediation analyses were performed to explore potential mediating factors. The results showed that LDLR, LPL agonists and APOC3 inhibitors were significantly associated with a reduced risk of ED occurrence. APOB inhibitors were associated with an increased risk of ED occurrence. In terms of sex hormone levels, LDLR and LPL agonists were significantly associated with increased TT levels, and HMGCR was associated with decreased TT and BT levels significantly. In terms of male-related disease, MR results showed that LDLR agonists and PCSK9 inhibitors were significantly associated with an elevated risk of PH; HMGCR, NPC1L1 inhibitors were associated with a reduced risk of PCa; and LDLR agonists were significantly associated with a reduced risk of AS and MI; in addition, HMGCR inhibitors were associated with a reduced risk of PCa. After performing drug-targeted MR analysis, we found that that there was a causal relationship between lipid-lowering drug targets and ED. APOC3, APOB, LDLR and LPL may be new candidate drug targets for the treatment of ED.

Study protocol for a randomized controlled trial testing the efficacy of Emotion Detectives In-Out: a blended version of the unified protocol for transdiagnostic treatment of emotional disorders in Portuguese children

BackgroundChildhood emotional disorders (EDs; i.e., anxiety and depressive disorders) are currently a public health concern. Their high prevalence, long-term effects, and profound influence on the lives of children and families highlight the need to identify and treat these disorders as early and effectively as possible. This clinical trial will examine the efficacy of a blended version (i.e., combining face-to-face and online sessions into one treatment protocol) of the Unified Protocol for Children (the “Emotion Detectives In–Out” program). This program is a manualized cognitive-behavioral therapy for the transdiagnostic treatment of EDs in children aged 7 to 12 years that aims to reduce the intensity and frequency of strong and aversive emotional experiences by helping children learn how to confront those emotions and respond to them in more adaptive ways.MethodsThis study is designed as a multicenter equivalence randomized controlled parallel-group two-arm trial comparing the Emotion Detectives In–Out program with an evidenced-based group intervention for children with anxiety disorders (the Coping Cat program). Participants will be children aged between 7 and 12 years with an anxiety disorder or with clinically significant anxiety symptoms as well as one of their parents or a legal representative. A minimum sample size of 138 children (69 per group) is needed to test whether the efficacy of the proposed intervention is equivalent to that of the well-established Coping Cat intervention.DiscussionWe expect Emotion Detectives In–Out to be a feasible and efficacious alternative intervention for treating children's EDs by allowing for a greater increase in children's access to care. A blended format is expected to overcome common barriers to treatment (e.g., parents´ lack of time to attend regular sessions) and make the intervention more accessible to families.Trial registrationThe clinical trial is registered at ClinicalTrials.gov (Identifier: NCT05747131, date assigned February 28, 2023).

(045) Comparing Bacterial Presence with the Usage of 0.05% Chlorhexidine Gluconate (CHG) Lavage During Urologic Prosthesis Revision Surgery: Update on Results

Abstract Introduction An Inflatable Penile Prosthesis (IPP) is third line surgical therapy for refractory ED. An IPP uses a fluid-filled reservoir with a pump and valve system to activate inflation and deflation. Although penile implants achieve the highest success rates in ED treatment, the possible presence of bacteria on the device itself or bacteria exposure accumulated during the surgery increases the risk of progression into biofilm or infection. Biofilm complicates the bacteria eradication effort and can ultimately jeopardize the implant. Often, the only way to treat the post-op infection is with implant removal. Currently, many preventative measures, such as different perioperative irrigations, are being studied to reduce the number of penile implant infections. Research has shown that irrigation at the time of both infectious and noninfectious surgery lowers subsequent infection rates. Different solutions like saline, antibiotic, betadine, and hydrogen peroxide solutions have been considered. Recently, orthopedic literature has shown that 0.05% Chlorhexidine Gluconate (CHG) lavage has effectively reduced biofilm in artificial joint procedures. Objective The purpose of this study is to determine the effectiveness of CHG lavage on bacterial presence in IPP implant spaces. We hypothesize that CHG will lower bacterial presence after washing out implant spaces at time of replacement for infections and mechanical failure. Methods We aimed to investigate a series of patients who underwent revision IPP surgery while utilizing FDA-approved CHG lavage for irrigation and compared the bacterial presence before and after CHG washout. Additionally, Next Generation Sequencing (NGS), a DNA sequencing technology, was used to further identify the pathogens involved. Results Between 2021 to 2023, 48 patients underwent IPP revision surgery for either infectious or noninfectious reasons. During the operation, a section of the capsule tissue surrounding the implanted IPP pump was first taken and sent for cultures. NGS studies were also sent out. After the implant removal, all implant spaces were irrigated and washed out with CHG (two 450-mL bottles). A second tissue culture was then obtained post washout. Of the 48 patients, there were 4 positive bacterial cultures before washout and 13 positive NGS results. Results of the post CHG washout cultures were all negative. Conclusions It appears that irrigation with 0.05% Chlorhexidine Gluconate solution is an effective antiseptic that can decrease bacterial presence, and hopefully reduce IPP infections. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Microgen Dx, Irrisept.