(390) Combining a Nitric Oxide Boosting Dietary Supplement With Sildenafil Improves Nighttime Erections More Than Sildenafil Alone

Introduction Nitric Oxide boosting supplements are known to increase circulation. L-Citrulline is converted into Arginine in the body, producing nitric oxide that relaxes blood vessels and improves blood flow. Beetroot extract potentially improves erectile function due to its high nitrate content, which the body converts into nitric oxide which helps dilate blood vessels and improves circulation. Nighttime erections can be measured and can provide an excellent indicator of erectile health. Objective We sought to determine if ingesting a Nitric Oxide boosting dietary supplement 1 hour before sleep can improve nighttime erectile function by using a device that measures penile pressure while sleeping. Methods Ten men completed the study. Average age 52. Average SHIM score 18. A single tablet of the Nitric Oxide boosting dietary supplement contains 750 mg L-Citrulline, 65 mg Muira Puama Extract 4:1, Red Beet Root extract 45 mg 4:1, Panax Ginseng Root Extract 35 mg 4:1. This supplement is commercially available as AFFIRM. Participants wore the TechRing by FirmTech during sleep to measure nighttime erectile function. The TechRing uses 2 sensors and an AI interface to measure on a 1-10 scale the firmness of erections and their duration. The data has been validated by independent researchers, and it's safety has been affirmed in a large study presented at the recent AUA meeting in 2024. The research protocol was a 2-day washout period with no ejaculation, ED medications, or supplements. Day 1 and Day 2 participants did not ejaculate and did not take any ED medications or supplements and they wore the TechRing while sleeping. On day 3 and Day 4, participants took 2 supplement tablets 1 hour before sleep and wore the TechRing while sleeping. To standardize the results between patients and between days, we calculated the area under the curve per hour of sleep as a measure of erectile activity. Results The area under the curve per hour of sleep (AUC/hr) of the men with no dietary supplement was 11.9 mean and the AUC/hr on the two days when participants took the supplement was 15.8. The mean difference was 3.89 and the p-value was 0.0001. 95% Confidence Interval was (-5.6 to -2.2). The number of erections per night on average was 4.05 with no dietary supplement and 4.45 with dietary supplement. There was no significant difference in the number of erections per night and the p-value is 0.42. No side effects were reported from taking the dietary supplement. AUC/hr mean AUC/hr median Number of Erections NO Supplement 11.9 11.5 4.05 Yes Supplement 15.8 15.2 4.5 Mean Difference 3.89 3.7 0.45 p-value 0.0001 0.428 Conclusions A Nitric Oxide boosting dietary supplement consisting of L-citrulline, Red Beet Root Extract, Ginseng, and Muira Puama increased the duration and intensity of nighttime erections but did not increase the number of erections in men. A Nitric Oxide boosting dietary supplement with L-Citrulline, Beet Root Extract, Panax Ginseng and Muira Puama taken before sleep improves genital circulation at night without negative side effects. This supplement may also improve genital circulation during sexual activity and may be synergistic with PDE-5 inhibitors. Additional studies are ongoing to study this issue further. Disclosure Yes, this is sponsored by industry/sponsor: BrandeisMD. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.

Introduction Tools to assess a man’s erectile function (EF) are currently limited. The Sexual Health Inventory of Men (SHIM) is a validated questionnaire that is easy to administer, but suffers from significant subjectivity, need for patient to actively attempt intercourse, and inability to distinguish vasculogenic from psychogenic erectile dysfunction (ED). Penile Doppler ultrasound (US) can provide objective measurements of cavernosal arterial blood flow, but suffers from high cost, invasiveness, and unreliability in the setting of suboptimal erections. The presence of nocturnal, spontaneous erections is considered a marker of EF, but is difficult to objectively measure. The FirmTech Tech Ring is a novel penile constriction ring with built-in sensors that connect with a smartphone app to record the number and duration of erections. Objective We conducted a small pilot study to assess the utility of the FirmTech Tech Ring to measure the quality of spontaneous, overnight erections in men. Methods Following Institutional Review Board approval, 9 male patients (aged 23–82 years) presenting to a Men’s Health clinic were recruited. 7 patients endorsed ED and 2 patients denied ED. Each patient was asked to fill out a SHIM, then provided with a device and asked to wear it overnight while asleep. Data were collected through the smartphone app and sent to a centralized database. Pearson’s correlation coefficient was used to determine the association between SHIM scores and erection parameters. 1-way ANOVA was used to compare the +ED and -ED groups. Results There were no significant correlations between SHIM scores and the measured parameters (# of overnight spontaneous erections; average duration of each erection). However, when comparing the +ED group against the -ED group, the former had significantly shorter average duration of erections (23.8 min vs. 38.9 min, p = 0.018). The number of spontaneous erections/night did not differ between the +ED and -ED groups (2.67 vs. 3, p = 0.77). Conclusions We report preliminary data suggesting that the FirmTech Tech Ring may be a convenient, noninvasive tool to objectively measure patients’ EF. Despite the small sample size, we noted that patients with self-reported ED had significantly shorter duration of spontaneous erections compared to patients who denied ED. Additionally, the # and duration of erections have no correlation with SHIM scores, highlighting the latter’s limitation in assessing a patient’s EF. However, further studies with larger patient cohorts, with various severities of ED and comparison against penile Doppler US results, are needed to validate these findings. Disclosure Yes, this is sponsored by industry/sponsor: FirmTech Inc. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: FirmTech Inc.

EFFECT OF THE SELECTIVE PHOSPHODIESTERASE TYPE 5 INHIBITOR SILDENAFIL ON ERECTILE FUNCTION IN THE ANESTHETIZED DOG

Can We Cure Erectile Dysfunction?

With an increase in the detection of structural and functional analogues of phosphodiesterase type 5 inhibitors (PDE-5i) in dietary supplements (DS) and foods, public health is threatened. Some products advertise natural ingredients despite containing PDE-5i that can cause serious adverse effects on human health. To avoid detection during routine screening, novel PDE-5i have been synthesised and added to DS and foods. The purpose of this study was to detect, identify, and quantify 94 PDE-5i and related compounds in DS and foods. Furthermore, the study investigated the detection cases and compared them by sample type, formulation, and compounds. The HPLC and LC-MS/MS methods were validated for limit of detection (LOD), limit of quantification (LOQ), linearity, and recovery in solid and liquid type samples. Both HPLC and LC-MS/MS showed satisfactory results, which were in conformance with the ICH guidelines. A total of 404 samples, including DS (99), and foods (305) were purchased from online and offline markets. Samples divided into 5 types of formulation were analysed; tablet, capsule, pilula (herbal medicine pill), powder and liquid type. Of these 130 samples (47 of 99 DS, and 83 of 305 foods) contained one or more PDE-5i or related compounds. Among the five types of formulation, the tablet type showed the highest detection rate (61.1%) in DS, whereas the capsule type showed the highest detection rate (53.8%) in food samples. This study will be helpful for monitoring illegal ED-related products, providing information to consumers, and ultimately contributing to protecting public health.

Evidence for the use of combination targeted therapeutic approaches for the management of pulmonary arterial hypertension

Phosphodiesterase type 5 inhibitors (PDE-5i) are the common oral medications prescribed for the treatment of erectile dysfunction (ED). In recent years, health supplements have gained popularity as alternative options to prescription PDE-5i. However, concerns have emerged regarding the adulteration of these products with undeclared synthetic PDE-5i or their analogues, posing significant health risks. In this study, a rapid, simple, and efficient analytical method for the determination of PDE-5i was developed and validated using a liquid chromatography–tandem mass spectrometry system (LC-MS/MS) for the rapid detection of these compounds in health supplement products collected in Hanoi. The method demonstrated excellent linearity (R² ≥ 0.999). The limits of detection (LOD) and quantification (LOQ) were 1.5 µg/kg and 5.0 µg/kg for sildenafil, tadalafil, and vardenafil, and 15 µg/kg and 50 µg/kg for the remaining PDE-5i. Recoveries ranged from 80.9% to 113% with relative standard deviations (%RSD) below 15%. The validated procedure was applied to 24 real-world samples, and 13 of them were found to contain PDE-5i. Further comprehensive investigations involving larger sample sizes and additional PDE-5i compounds are necessary to better assess adulteration practices and potential health risks.

Drug Treatment of Raynaud's Phenomenon of the Nipple.

Erectile Dysfunction

Objective: to determine the effectiveness of beet root extract as an anti-aging, nephroprotector, and anti-hypercholesterolemia in Wistar rats induced with D-galactose to maximize the use of beetroot as a health supplement. Study Design: Laboratory-based experimental study. Place and Duration of Study: Laboratory of Faculty of Medicine, Universitas Prima, Indonesia, and Pharmacy Laboratory, Universitas Sumatera Utara, Indonesia, from Jun 2023 to Aug 2023. Methodology: The study sample consisted of 25 male Wistar rats aged six to eight weeks that were obtained from the Pharmacy Laboratory and had gone through the inclusion and exclusion criteria. The sample was then induced by D-galactose and given an intervention using beetroot extract and vitamin C. Results: Beetroot extract at a dose of 500 mg/kg body weight showed more significant results as anti-aging, nephroprotector, and anti-hypercholesterolemic compared to 250 mg/kg body weight. Mean value of Group C for anti-aging was 136.26±15.16 (keratinocyte cells) and 35.93±10.64 (fibroblast cells), which was slightly lower than Group D, 136.86±4.29 (keratinocyte cells) and 43.80±5.80 (fibroblast cells). Ureum mean value of Group C for nephroprotector was 79.00±3.16, which was significantly lower than Group D (127.20±6.26) and Group E (105.00±4.63), but creatinine in Group E was the lowest with a mean value of 105.00±4.63 compared to Group C (0.83±0.08) and Group D (0.74±0.07). Group E had the lowest mean value, 105.00±4.63, for total cholesterol compared to Group C (165.00±16.12) and Group D (127.20±6.26). Conclusion: This experimental study proved the positive effects of beet root extract as anti-aging, nephroprotective, and antihypercholesterolemic on the

Adherence to Initial PDE5 Inhibitor Treatment: Randomized OpenLabel Study Comparing Tadalafil Once a Day, Tadalafil on Demand, and Sildenafil on Demand in Patients with Erectile Dysfunction

Objective The method for simultaneous determination of 9 PDE5 inhibitors in Chinese patent medicines and dietary supplements was developed using the UPLC-HRMS coupled with d-SPE technique. Methods The samples were extracted with 0.1% acidic acetonitrile and cleaned up with d-SPE by using mixture of C18, PSA and magnetic Fe3O4 as sorbents. The analyses were operated under Full Scan/ddms2 by HRMS. Results The results showed a good linearity in the range of 5-500 ng/L (r>0.999). The LODs and LOQs for the 9 PDE5 inhibitors were 2 μg/kg and 5 μg/kg, respectively. The recovery results at the levels of 5-500 μg/kg were satisfied with average recovery rates of 87.6%-108.9% and the RSD of 1.9%-7.2%. The method was applied for the determination of the real samples, and homosildenafil was detected as illegal addtives from the samples. Conclusions The results showed that the method was suitable for the analyses for 9 PDE5 inhibitors in Chinese patent medicines and dietary supplements. Key words: Chinese patent drugs; Health food; Solid phase extraction; High resolution mass spectrometry; Phosphodiesteras 5 inhibitors

A novel ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) method was developed to detect the illegal additive of phosphodiesterase type 5 (PDE-5) inhibitors in dietary supplements. With the optimized chromatographic program, vardenafil, sildenafil, and tadalafil were separated within 5 minutes. The MS1, MS2, and retention time of PDE-5 inhibitors were acquired simultaneously within the information dependent acquisition mass spectrometry mode. Quantification was achieved via the quantity ion current chromatogram that was extracted from the total ion current. The linear range of vardenafil and sildenafil was 0.5-48 mg/L while the range of tadalafil was 0.3-36 mg/L. The correlation coefficients of the calibration curves of three PDE-5 inhibitors were all greater than 99.9%. At three concentration levels, the RSD values of the five repeat tests were all better than 1.30%. Sildenafil was detected in one dietary supplement. The comprehensive method of this study is reliable and may be a powerful tool for routine PDE-5 inhibitor screening and determination.

In recent years, phosphodiesterase type 5 (PDE5) inhibitors have been proposed for relieving the ureteral stent-related symptoms. We conducted a meta-analysis to assess the efficacy and safety of PDE5 inhibitors in the treatment of ureteral stent-related symptoms. Randomized controlled trials (RCTs) that reported on the effectiveness of PDE5 inhibitors on ureteral stent-related symptoms were identified and collected from Medline, Embase, and Cochrane Library databases. Four RCTs involving 352 patients were included. Following treatment with PDE5 inhibitors for 1 week, significant improvement of urinary symptoms (P<0.00001) and sexual health (P=0.04) was observed in the PDE5 inhibitors group. After 3 weeks, we found that PDE5 inhibitors were effective in relieving urinary symptoms [mean difference (MD): -11.94, 95% confidence interval (CI): -22.58 to -1.3, P=0.03], body pain (MD: -5.38, 95% CI: -9.35 to -1.41, P=0.008), and improving sexual health (MD: -4.13, 95% CI: -5.07 to -3.19, P<0.00001), general health (MD: -3.92, 95% CI: -5.76 to -2.08, P<0.0001), and additional health (MD: -2.21, 95% CI: -4.03 to -0.40, P=0.02). With regards to work performance (MD: -2.25, 95% CI: -5.13 to -0.62, P=0.12), no significant differences were observed between the PDE5 inhibitors group and the placebo group. In terms of safety, there were no significant differences between these two groups in the incidence of gastrointestinal [odds ratio (OR): 1.25, 95% CI: 0.51 to 3.04, P=0.63], or respiratory (OR: 1.48, 95% CI: 0.50 to 4.44, P=0.48) complications. PDE5 inhibitors were effective in relieving symptoms of patients undergoing ureteral stent placement, and do not increase the risk of complications.

Can Low-Intensity Extracorporeal Shockwave Therapy Improve Erectile Function? A 6-Month Follow-up Pilot Study in Patients with Organic Erectile Dysfunction