Sexual Health Inventory For Men Research Articles

Combined holmium laser enucleation of the prostate with high-intensity focused ultrasound in treating patients with localized prostate cancer in a prostate with volume > 60 g: Oncological and functional outcomes from single-institution study

ObjectiveTo assess the efficacy and safety of combined High-Intensity Focused Ultrasound (HIFU) and Holmium Laser Enucleation of the Prostate (HoLEP) in treating patients with both localized prostate cancer (PCa) and prostate > 60 g. MethodsAll patients who underwent HIFU for treatment of localized PCa were prospectively enrolled in our study. We reviewed records of patients undergoing procedures from January 2016 to January 2023. For patients with prostate sizes > 60 g, HoLEP was offered before HIFU to prevent worsened urinary symptoms post-treatment. Oncological outcomes—prostatic-specific (PSA) kinetics, recurrence rates, treatment failure - and functional results—Sexual Health Inventory for Men (SHIM), International Prostate Symptoms Score (IPSS), and urinary complications were compared between patients undergoing combined HoLEP and HIFU with those underwent HIFU-monotherapy. ResultsAmong 100 patients, 74 underwent HIFU-monotherapy and 26 underwent the combined HoLEP and HIFU. The majority had intermediate-risk PCa (67%). Pathologic assessment of HoLEP specimens showed no tumor evidence in 57% of cases. In comparison to the HIFU-only group, the combined group exhibited significantly lower PSA metrics across various intervals, however, no differences were found regarding overall and infield recurrences and treatment failure rates. While the combined treatment initially resulted in higher incontinence rates and shorter catheterization durations (P < 0.001), no significant difference in IPSS was observed during subsequent follow-ups. ConclusionHoLEP and HIFU can be safely combined for the treatment of PCa in patients with >60 g prostate volume without compromising early oncological outcomes thereby expanding the therapeutic scope of HIFU in treating patients with localized PCa and large adenomas.

Real-world short-term outcomes of prostate urethral lift in Japan: A prospective cohort study.

We report the first prospective trial of prostatic urethral lift for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia in Japan. This prospective study was conducted at a single institution and included patients with benign prostatic hyperplasia who underwent prostatic urethral lift based on the Japanese surgical indication. The primary efficacy endpoint was reduced international prostatic symptoms score in the early postoperative period after prostatic urethral lift. To assess efficacy, international prostatic symptoms score, quality of life, sexual health inventory for men, and uroflowmetry were evaluated 2 weeks before, 2 weeks after, and 6 weeks after surgery. We enrolled 120 elderly men. The patients experienced significantly reduced international prostatic symptoms scores from 15 at the baseline to 13 at 2 weeks, and to 10 at 6 weeks, respectively. The peak flow rates did not change significantly at any time point. Three patients had serious adverse events of grade 3a in the Clavien-Dindo classification. Four patients were evaluated for sexual function, and none had ejaculatory dysfunction. In the Japanese population, prostatic urethral lift is reliably performed under local anesthesia and rapidly improves symptoms.

Impact of neoadjuvant relugolix on patient-reported sexual function and bother.

Sexual function following local treatment for prostate cancer is an important quality of life concern. Relugolix is a novel oral GnRH receptor antagonist used in combination with radiation therapy in the treatment of unfavorable prostate cancer. It has been shown to achieve rapid and profound testosterone suppression. As a result, these very low testosterone levels may impact both sexual functioning and perceptions. This prospective study sought to assess neoadjuvant relugolix-induced sexual dysfunction prior to stereotactic body radiation therapy (SBRT). Between March 2021 and September 2023, 87 patients with localized prostate cancer were treated with neoadjuvant relugolix followed by SBRT per an institutional protocol. Sexual function and bother were assessed via the sexual domain of the validated Expanded Prostate Index Composite (EPIC-26) survey. Responses were collected for each patient at pre-treatment baseline and after several months of relugolix. A Utilization of Sexual Medications/Devices questionnaire was administered at the same time points to assess erectile aid usage. The median age was 72 years and 43% of patients were non-white. The median baseline Sexual Health Inventory for Men (SHIM) score was 13 and 41.7% of patients utilized sexual aids prior to relugolix. Patients initiated relugolix at a median of 4.5 months (2-14 months) prior to SBRT. 95% and 87% of patients achieved effective castration (≤ 50 ng/dL) and profound castration (< 20 ng/dl) at SBRT initiation, respectively. Ability to have an erection, ability to reach orgasm, quality of erections, frequency of erections, and overall sexual function significantly declined following relugolix. There was a non- significant increase in sexual bother. In concordance with known side effects of androgen deprivation therapy (ADT), neoadjuvant relugolix was associated with a significant decline in self-reported sexual function. However, patients indicated only a minimal and non-significant increase in bother. Future investigations should compare outcomes while on relugolix directly to GnRH agonist-induced sexual dysfunction.

Erectile dysfunction criteria of 131,350 patients after open, laparoscopic, and robotic radical prostatectomy.

Comparing post-radical prostatectomy erectile function rates among different techniques has always been a challenge in urology. This difficulty is due to the heterogeneity of studies, mainly in relation to the type of erectile function classification criteria used. The aim is to apply a new evidence-gathering methodology, called reverse systematic review, to compare erectile function rates among retropubic radical prostatectomy, laparoscopic radical prostatectomy, and robot-assisted radical prostatectomy, considering the diversity of classification criteria. A search was carried out in eight databases between 2000 and 2020 through systematic review studies referring to retropubic radical prostatectomy, laparoscopic radical prostatectomy, or robot-assisted radical prostatectomy (80 systematic reviews). All references used in these systematic reviews were captured by referring to 910 papers in a global database called EVIDENCE. A total of 268 studies related to post-prostatectomy erectile function rates were selected for the final analysis, totaling 465 cohorts or reports referring to 131,350 patients. Note that, 119 (25.6%) reports for retropubic radical prostatectomy, 143 (30.7%) reports for laparoscopic radical prostatectomy, and 203 (43.7%) reports for robot-assisted radical prostatectomy were found. Mean overall erectile function rates, respectively for retropubic radical prostatectomy, laparoscopic radical prostatectomy, and robot-assisted radical prostatectomy, were: 16%, 12%, and 35% at 1 month, 22%, 26%, and 42% in 3 months; 30%, 44%, and 54% at 6 months, 41%, 55%, and 59% at 12 months, and 58%, 52%, and 67% at more than 18 months. The most used erectile function criterion was Erection Sufficient for Intercourse (74.1%), followed by Sexual Health Inventory for Men>21 (5.5%), and Sexual Health Inventory for Men>16 (3.7%). Erection Sufficient for Intercourse showed the lowest discrepancy in erectile function rates in each period compared to the global average, for each technique, demonstrating less ability to influence the final results, favoring any of the techniques. The reverse systematic review demonstrated that the robot-assisted radical prostatectomy showed higher rates of erectile function recovery at all times analyzed (1->18 months), in relation to the retropubic radical prostatectomy and laparoscopic radical prostatectomy. The Erection Sufficient for Intercourse criterion was the most used in the literature and showed the lowest bias capable of influencing the results and favoring any of the techniques and might be the fairest option for future comparisons.

Psychological Impact of Sexual Disorders Related to Benign Prostatic Hypertrophy

Objectives: Lower urinary tract disorders related to BPH are today among the most frequent symptoms in urology. The aim of our study is to determine the prevalence of erectile dysfunction in patients with BPH-related lower urinary tract symptoms and the related psychological impact. Methods: We conducted a study to assess the psychological impact of BPH-related sexual dysfunction. We used two scores to assess anxiety-depressive symptoms. The Patient Health Questionnaire-9 (PHQ-9), which gives an indication of the severity of depression, and the Generalized Anxiety Disorder - 7 (GAD-7) 1 for screening patients for generalized anxiety disorder. The severity of erectile dysfunction was specified using the SHIM score (Sexual Health Inventory for Men). Results: A total of 290 participants. The mean age was 58 years, 175 (60%) patients had erectile dysfunction, 120 (60%) of these patients with ED were treated with alpha blockers (OR=2.38, RR = 1.43, p = 0.04). The most represented age group was 60-69 years, 50 (28%) patients were treated with alpha blockers (OR=1.67, RR = 1.15, p = 0.01) while only 10 (5.7%) patients were treated with herbal extracts (phytotherapy). 65% of participants with erectile dysfunction showed varying degrees of depression and 53% of participants with erectile dysfunction showed varying degrees of anxiety. Conclusion: Micturition disorders caused by benign prostatic hyperplasia (BPH) and erectile dysfunction are frequent and often coexist. BPH-related erectile dysfunction has a significant psychological impact.

(068) The Men’s Training Cup Keep Training: A Masturbation Aid Improves Intravaginal Ejaculatory Latency Time and Erection Hardness Score in Patients who are Unable to Delay Ejaculation

Abstract Introduction Premature ejaculation (PE) has negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy. In Japan, no oral drugs or devices are approved or used clinically to treat PE. The Men’s Training Cup Keep Training (MTCK), a masturbation aid, was developed for PE. MTCK offers 5 grades of tightness and strength. Objective We aimed to investigate the efficacy of the MTCK in patients who are unable to delay ejaculation. Methods Inclusion criteria were 20- to 60-year-old men feeling distressed and frustrated by PE and who had the same sexual partners throughout the study period. Exclusion criteria were neurologic disease and uncontrolled diabetes mellitus, as well as the use of antidepressants, α-blockers, and 5α-reductase inhibitors. The protocol comprised an 8-week training period with the MTCK from level 1 to level5, with each level used twice before moving to the next level. The main outcome measure was the extension of intravaginal ejaculation latency time (IELT). The secondary outcome measures were score improvements on the Premature Ejaculation Diagnostic Tool, Sexual Health Inventory for Men, Erection Hardness Score, and Difficulty in Performing Sexual Intercourse Questionnaire–5. Results We enrolled 37 patients, and after 19 patients withdrew, 18 concluded the study without experiencing any adverse events. The mean patient age was 39.9 years. Geometric IELT after the 8 week training with the MTCK increased significantly (mean ± SE; 232.10 ± 72.16 seconds) vs baseline (103.91 ± 50.61 seconds, P=.006). Mean scores on the Premature Ejaculation Diagnostic Tool, Difficulty in Performing Sexual Intercourse Questionnaire–5, and Erection Hardness Score after 8-week training improved significantly vs the baseline values. The mean score on the Sexual Health Inventory for Men did not improve significantly after the 8-week training, but domain 1 did significantly improve after 8 weeks of MTCK use. Conclusions The MTCK may be one possible treatment option for patients who are unable to delay ejaculation. Also, the MTCK may offer benefits for erectile function. Disclosure No.

(029) Safety and Efficacy of Botulinum Neurotoxin in the Treatment of Erectile Dysfunction Refractory to Phosphodiesterase Inhibitors: Results of a Randomized Controlled Trial

Abstract Introduction There has been recent interest in the use of botulinum neurotoxin (BoNT) in the field of Andrology, whereby it has been investigated in the treatment of penile retraction and premature ejaculation. Objective To evaluate the safety and efficacy of intracavernosal BoNT-A injection in the treatment of patients with erectile dysfunction (ED) refractory to oral phosphodiesterase inhibitors (PDE5Is). Methods A double-blind randomized placebo-controlled prospective comparative study conducted at one center and involved 70 patients with ED refractory to PDE5Is. At baseline, the following data were collected: erection hardness score (EHS), peak systolic velocity (PSV), end diastolic velocity (EDV), sexual health inventory for men (SHIM), and the sexual encounter profile 2&amp;3 (SEP-2&amp;3) questionnaires. Treatment group (n = 35) received a single ICI of 100 units of BoNT-A in 2 ml of saline and control group (n = 35) received a single ICI of 2 ml of saline. EHS, PSV, and EDV were assessed at 2 weeks post treatment. SHIM, SEP-2, SEP-3, and global assessment questionnaire (GAQ-Q1&amp;Q2) were completed at 2-, 6-, and 12-weeks post treatment. Results Two weeks post treatment, the treatment group showed a statistically significant improvement in the mean EHS, PSV, EDV, and GAQ-Q1 positive responders (p &amp;lt; 0.001) compared to the control group. At 6- and 12-weeks post treatment, the treatment group showed a statistically significant improvement in the SHIM scores, SEP-2, and GAQ-Q1&amp;Q2 positive responders compared to the control group. At 6 weeks, where there was a 5-point improvement in the mean SHIM score of the treatment group (10±5.9 from 5.4±1.7 at baseline) versus no improvement in the placebo group, 18 patients in the treatment group (53%) were able to have an erection hard enough for vaginal penetration versus only one patient in the control group. Conclusions BoNT-A is safe and effective as a potential treatment for ED refractory to PDE5I therapy. Disclosure No.

(108) Evaluation the Efficacy and Safety of Hyperbaric Oxygen Therapy in Sildenafil Citrate Non Responder Organic Erectile Dysfunction Patients: a Randomized Double Blinded Controlled Clinical Trial

Abstract Introduction Although the phosphodiesterase 5 inhibitors (PDE5i) are the first-line oral agents for erectile dysfunction (ED) treatment, there is growing number of PDE5i- non responder patients. Management of those patients is challenging and one of the new suggested regenerative therapies is the hyperbaric oxygen therapy (HBOT). HBOT is the application of oxygen under pressure to increase tissue oxygen levels. Few clinical reports were published about HBOT and ED. Objective To evaluate the efficacy and safety of HBOT in sildenafil citrate non- responder organic ED patients. Methods The current study included 30 sildenafil citrate non-responder ED patients. Patients were divided into two groups (randomly assigned and comparably cross-matched for age). Both patients and the investigators were blinded as regards the treatment until the end of the study. Group 1: Patients assigned to the HBOT group (20 patients) were treated with (30) sessions in 5 days/week (90 minutes of 100% oxygen at 2.2 ATA); Group 2: Patients assigned to the control group (10 patients) were exposed to (30) sessions of air oxygen tension at 1 ATA with room oxygen. Baseline laboratory investigations were done (random blood sugar, lipid profile, total &amp; free testosterone). All patients were evaluated with the sexual health inventory for men (SHIM), erection hardness score (EHS), the sexual health encounter profile (SEP), and penile color Doppler initially, at 1 &amp; 3 months after the end of treatment. Results The age mean ± SD in the HBOT group was 56.35±7.43 years and in the control group was 61.7±7.14 years. The current study showed that sildenafil citrate non-responders ED patients with 30 sessions of HBOT in 5 days/week, demonstrated a significant improvement of the total SHIM score, EHS, and SEP after 1 month of stoppage of treatment as compared to the control group. Also, penile color Doppler evaluation showed a significant improvement of 10 &amp;20 minutes peak systolic velocity (PSV) between patients receiving HBOT compared to the control after 1 month of stoppage of treatment. More interestingly, the improvement of the total SHIM score, EHS, and SEP continued after 3 months of stoppage of the HBOT treatment as compared to the baseline evaluation. In addition, 10 &amp;20 minutes PSV with penile color Doppler evaluation demonstrated maintained improvement after 3 months of stoppage of the HBOT treatment as compared to the baseline evaluation. In addition, the linear regression analysis was done for factors affecting SHIM score improvement (1 month/baseline) in the HBOT treatment group, revealing that hypertension was an independent predictor for SHIM score improvement. Hypertensive patients showed 4.6 times more SHIM score improvement as compared to non-hypertensive patients. As regards HBOT safety, there was no significant difference in adverse effects between the HBOT treatment group and the control group. Conclusions HBOT might be a potential therapeutic modality for sildenafil citrate non-responder ED patients especially in hypertensive patients with good safety profile. Further a multi-centric trial with a larger sample size and a longer follow-up period is recommended. Disclosure No.

(111) Penile Constriction Device Satisfaction: Does Sexual Preference Have Any Effect on Preferences and Effectiveness?

Abstract Introduction Penile constriction devices are a noninvasive way to improve sexual performance and erectile function, making them an appealing choice for men. To understand their clinical value and patient satisfaction, it is important to assess patient preferences and the efficacy of different devices. Comparative studies between heterosexual and homosexual men are also necessary to recognize and meet the diverse needs and experiences of these populations, leading to more tailored and effective recommendations. Objective To assess and compare the preference and effectiveness of two medical-grade penile constriction devices between heterosexual and homosexual men. Methods Between May 2023 and July 2023, males were recruited via social media platforms and prospectively enrolled into an IRB-approved, randomized, questionnaire-based study. Upon enrollment, the participants completed the Sexual Health Inventory for Men (SHIM) and Androgen Deficiency in Aging Males (ADAM). Participants were then randomized to which device (FirmTech vs by Giddy) they would receive first and were instructed to use the device twice either during masturbation or intercourse within a two-week timeframe. Once utilized, the participants completed a 17-question, five-point Likert scale device satisfaction questionnaire. Once the first device and survey were completed the other device was sent and the process was repeated. In the device satisfaction questionnaire, lower numbers indicated more positive responses to the questions. We then took the data collected and matched 2 homosexual participants to 1 heterosexual participant by age. Responses from the questionnaire with numerical values are presented as the mean difference (MD) and analyzed using a paired t-test. Questionnaire responses that were “yes” or “no” were analyzed using McNemar’s chi-square analysis. A p-value less than 0.05 was considered significant. Results Fifty men were enrolled and 44 completed the study. After matching the patients by age, 21 were included in the analysis. Among the 21 participants, 14 (66.7%) were homosexual and 7 (33.3%) heterosexual. There was no statistically significant preference or effectiveness amongst the heterosexual group for either device. However when comparing both devices within the homosexual group, 11 (78.6%)) would recommend the FirmTech to a friend, compared to 5 (35.7%) who would recommend the Eddie by Giddy device (p=0.0412). Within the homosexual group, they preferred the ease of putting on the device while flaccid and erect and its comfort (MDs -1.14, -1.79, and-1.50; respective p-values 0.0019, 0.0010, and 0.0160). Homosexual participants also had a significantly better overall impression of the FirmTech device (MD=-0.79; p=0.0099). Lastly, the homosexual participants were significantly more likely to use the FirmTech device in partnered sex as compared to the Giddy (MD=-01.36, p=0.0038). Conclusions These findings suggest that homosexual men favor the FirmTech device over the Eddie by Giddy, rating it more positively and being more likely to recommend it to a friend. Further research with a larger and more diverse sample is needed to fully comprehend the different preferences and satisfaction with penile constriction devices among men with different sexual orientations. Disclosure Yes, this is sponsored by industry/sponsor: FirmTech Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: FirmTech.

(367) Penile Constriction Device Satisfaction: Does Sexual Preference Have Any Effect on Preferences and Effectiveness?

Abstract Introduction Penile constriction devices are a noninvasive way to improve sexual performance and erectile function, making them an appealing choice for men. To understand their clinical value and patient satisfaction, it is important to assess patient preferences and the efficacy of different devices. Comparative studies between heterosexual and homosexual men are also necessary to recognize and meet the diverse needs and experiences of these populations, leading to more tailored and effective recommendations. Objective To assess and compare the preference and effectiveness of two medical-grade penile constriction devices between heterosexual and homosexual men. Methods Between May 2023 and July 2023, males were recruited via social media platforms and prospectively enrolled into an IRB-approved, randomized, questionnaire-based study. Upon enrollment, the participants completed the Sexual Health Inventory for Men (SHIM) and Androgen Deficiency in Aging Males (ADAM). Participants were then randomized to which device (FirmTech vs Eddie by Giddy) they would receive first and were instructed to use the device twice either during masturbation or intercourse within a two-week timeframe. Once utilized, the participants completed a 17-question, five-point Likert scale device satisfaction questionnaire. Once the first device and survey were completed the other device was sent and the process was repeated. In the device satisfaction questionnaire, lower numbers indicated more positive responses to the questions. We then took the data collected and matched 2 homosexual participants to 1 heterosexual participant by age. Responses from the questionnaire with numerical values are presented as the mean difference (MD) and analyzed using a paired t-test. Questionnaire responses that were “yes” or “no” were analyzed using McNemar’s chi-square analysis. A p-value less than 0.05 was considered significant. Results Fifty men were enrolled and 44 completed the study. After matching the patients by age, 21 were included in the analysis. Among the 21 participants, 14 (66.7%) were homosexual and 7 (33.3%) heterosexual. There was no statistically significant preference or effectiveness amongst the heterosexual group for either device. However when comparing both devices within the homosexual group, 11 (78.6%)) would recommend the FirmTech to a friend, compared to 5 (35.7%) who would recommend the Eddie by Giddy device (p=0.0412). Within the homosexual group, they preferred the ease of putting on the device while flaccid and erect and its comfort (MDs -1.14, -1.79, and-1.50; respective p-values 0.0019, 0.0010, and 0.0160). Homosexual participants also had a significantly better overall impression of the FirmTech device (MD=-0.79; p=0.0099). Lastly, the homosexual participants were significantly more likely to use the FirmTech device in partnered sex as compared to the Giddy (MD=-01.36, p=0.0038). Conclusions These findings suggest that homosexual men favor the FirmTech device over the Eddie by Giddy, rating it more positively and being more likely to recommend it to a friend. Further research with a larger and more diverse sample is needed to fully comprehend the different preferences and satisfaction with penile constriction devices among men with different sexual orientations Disclosure Yes, this is sponsored by industry/sponsor: FirmTech and Eddie by Giddy 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- On Scientific Review Board.

(099) Intersection of Sexual and Mental Health: Prevalence of Anxiety and Depression in a Men's Health Clinic and Feasibility of Mental Health Surveys

Abstract Introduction Depression and general anxiety disorder (GAD) are the most prevalent mental health conditions in men, affecting 5% and 2%, respectively. 31% of men suffer depression in their lifetime and only 1/4 of men speak to a mental health professional about it. Suicide rates are 4 times higher in men and men are more likely to succeed at attempts. Men with high depression scores are nearly twice as likely to report erectile dysfunction (ED) than nondepressed men. Objective We aim to identify the prevalence of depression and GAD among patients presenting to a men's health clinic (MHC). Secondary objectives include demonstrating the feasibility of administering mental health surveys in a busy MHC to early identify men who may benefit from a referral to a mental health practitioner in order to improve overall men's health. Methods We retrospectively reviewed the records of patients presenting to a MHC during a three-month period in 2023 who completed all surveys. We measured ED and ejaculatory dysfunction severity with the Sexual Health Inventory for Men (SHIM) and Male Sexual Health Questionnaire (MSHQ-EJ), respectively. Screening for depression and anxiety was performed with the Patient Health Questionnaire (PHQ-7) and the General Anxiety Disorder (GAD-7) questionnaire. Both questionnaires rate disease severity as mild, moderate, or severe. Linear regression models were used to compare the severity of depression and anxiety to ED severity. Non-parametric statistics were used to analyze the prevalence of mental health disorders and the reason for the patient’s visit to the men’s health clinic. Referral to a mental health specialist was offered for any patients meeting scoring criteria. Results We identified 255 men (77% white, 18% black, 5% Asian, and 94% non-Hispanic) with a median age of 48 years (IQR: 33-64) and a BMI of 28 (IQR: 25-32). Overall, 63% of men had some ED, while 88% had some degree of ejaculatory dysfunction. Prevalence of depression and GAD was 15% and 11%, respectively. A linear regression model showed that as ED severity increases, so does depression severity (F [1, 244] = 13.53, p = .0001, coefficient: 0.15, R-squared: 0.05) and anxiety severity (F [1, 244] = 5.93, p=0.02, coefficient: 0.08, R-squared: 0.02). The study found no significant correlation between prevalence of depression and the reason for the patients' visits to the MHC: ED (17%, 20/117), hypogonadism (22%, 26/120), Peyronie's (28%, 7/25), fertility evaluation (33%, 5/15), varicocele (30%, 8/27), and vasectomy evaluation (5%, 1/21) (p=0.27). Conclusions The prevalence of depression and GAD among men attending a MHC is higher than that of the general male population. The degree of ED and its association with the severity of depression and anxiety emphasizes the importance of addressing both sexual and mental health in the context of men's healthcare. ED should be considered a multifactorial condition that requires a multidisciplinary approach to treatment, especially when depression is present. Patients reporting ED should be routinely screened for depression. Administration of mental health surveys in a MHC is feasible and helps guide early referral to a mental health specialist. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast and BK Ultrasound.

(135) A Randomized Survey Study Comparing the Preference and Effectiveness of Two Different Penile Constriction Devices

Abstract Introduction Penile constriction devices are a noninvasive way to improve sexual performance and erectile function, making them an appealing choice for men. To understand their clinical value and patient satisfaction, it is important to assess patient preferences and the efficacy of different devices. Comparative studies between heterosexual and homosexual men are also necessary to recognize and meet the diverse needs and experiences of these populations, leading to more tailored and effective recommendations. Objective To assess and compare the preference and effectiveness of two medical-grade penile constriction devices. Methods Between May 2023 and July 2023, males were recruited via social media platforms and prospectively enrolled into an IRB-approved, randomized, questionnaire-based study. Upon enrollment, the participants completed the Sexual Health Inventory for Men (SHIM) and Androgen Deficiency in Aging Males (ADAM). Participants were then randomized to which device (FirmTech vs Eddie by Giddy) they would receive first and were instructed to use the device twice either during masturbation or intercourse within a two-week timeframe. Once utilized, the participants completed a 17-question, five-point Likert scale device satisfaction questionnaire. Once the first device and survey were completed, the other device was sent and the process was repeated. In the device satisfaction questionnaire, lower numbers indicated more positive responses to the questions. Responses from the questionnaire with numerical values are presented as the mean difference (MD) and analyzed using a paired t-test. Questionnaire responses that were “yes” or “no” were analyzed using McNemar’s chi-square analysis. A p-value less than 0.05 was considered significant. Results Fifty men were enrolled and 44 completed the study. Among the participants, 31 (70.4%) identified as homosexual, 10 (22.7%) as heterosexual, and 3 (6.8%) as bisexual with a mean age of 36.5 (IQR = 16.5). Table 1 provides a summary of the demographic characteristics. The baseline mean SHIM and ADAM score was 19.5 and 0.5, respectively. A statistically significant preference for the ease of putting on the FirmTech device while erect was found (MD,-0.84; p = 0.001). There was also a statistically significant preference for the comfort, adjustability, and stretch of the FirmTech device (MDs -0.66, -0.32, and -0.86; respective p values 0.018, 0.033, and &amp;lt;0.001). Finally, 35 (79.5%) participants stated that they would recommend FirmTech to a friend, as opposed to 25 (55.6%) who would recommend Eddie by Giddy (p = 0.020). Conclusions These findings suggest that, when comparing penile constriction devices, men prefer the FirmTech device over the Eddie by Giddy with respect to ease of putting on the device, comfort, stretch, and adjustability. Men are more likely to recommend the FirmTech device over Eddie by Giddy. Further research with a larger sample size, which includes a more equal distribution of men of different sexual orientations, is warranted to further support the generalizability and validity of these initial findings, illustrate consumer preference for FirmTech, and expound upon its preferential qualities. Disclosure Yes, this is sponsored by industry/sponsor: FirmTech and Eddie by Giddy. 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- On Scientific Review Board.

Office-Based Transperineal Laser Ablation for Benign Prostatic Hyperplasia Under Local Anesthesia: 2-Year Results from a Dose Range Confirmatory Trial

Purpose: To evaluate the safety and tolerability profile of transperineal laser ablation (TPLA) for patients with benign prostatic hyperplasia in an office setting under sedative-free anesthesia, including the functional outcome results at 24 months. Materials and Methods: This is a prospective, single-center, dose range confirmatory trial involving 20 male patients. TPLA was performed by urologists in an office setting, using nonsedative local anesthesia. Self-administered nitrous oxide/oxygen dissociating gas was optional. Tolerability was assessed using a visual analog scale. Safety was evaluated by recording Grade 3 or worse adverse events within 30 days after the procedure. International Prostate Symptom Score, Sexual Health Inventory for Men, ejaculation function, and uroflowmetry parameters were assessed at 6, 12, and 24 months. Results: All 20 procedures were performed as intended without request of cessation from any patient, who tolerated them very well, recording a median pain score of 2 (range 1-4). It is important to note that there was a rapid escalation of dose, and the last 18 consecutive patients were initiated at the maximal energy dose of 7 watts. No hospital transfers were recorded, and no urgent hospital admissions within 30 days post-procedure occurred. There was 1 Grade 3 complication registered during the 24-month study interval. We observed a statistically significant and sustained reduction in the median International Prostate Symptom Score at 6 months (6, 3-8), 12 months (3, 5-2), and 24 months (3, 2-4) when compared with baseline values (14, 12-17). Uroflowmetry parameters showed a similar trend. The median Sexual Health Inventory for Men values did not change significantly, and only approximately 10% of patients reported absence of anterograde ejaculation at 12 and 24 months. Conclusions: TPLA for benign prostatic hyperplasia is a safe and well-tolerated office-based procedure, with durable benefits on functional outcomes over 2 years of follow-up. Further studies are required to confirm these results. NCT: NCT04760483.

A real-world pilot study assessing treatment satisfaction with avanafil in patients with erectile dysfunction.

Avanafil is a second-generation phosphodiesterase type 5 (PDE5) inhibitor, and offers a rapid onset of action (15minutes). Its real-world data, including treatment satisfaction, are still lacking. The study sought to investigate the treatment outcomes of avanafil and the factors impacting treatment satisfaction in a real-world setting. Between November 2021 and February 2023, erectile dysfunction (ED) patients prescribed avanafil were consecutively enrolled in this phase 4, open-label, cross-sectional, observational study. At each follow-up visit (4-week intervals), participants completed a questionnaire for assessing the use and treatment-emergent adverse events of avanafil, ED severity, and treatment satisfaction. The outcome measures included the Sexual Health Inventory for Men (SHIM), and Erectile Dysfunction Inventory of Treatment Satisfaction. Among 234 patients enrolled, 112 (47.9%) patients had follow-up visits and answered the questionnaire. Treatment with avanafil significantly improved the mean SHIM total score from 10.2 ± 5.6 at baseline to 17.5 ± 6.2 (P < .001). Of the patients treated with avanafil, 71.4% (n = 80 of 112) reported a >4-point improvement in the SHIM total score, and 33.1% (n = 37 of 112) reported normal erectile function. The proportion of patients satisfied with avanafil treatment (defined as Erectile Dysfunction Inventory of Treatment Satisfaction index score ≥60) was 87.5%. Several physical factors (younger age, lower waist circumference, and lower level of low-density lipoprotein), and sexual function factors (shorter duration of ED, higher SHIM total score at baseline, PDE5 inhibitor treatment naive, and acquired premature ejaculation) tended to contribute to satisfaction with avanafil treatment. Treatment-emergent adverse events occurred in 41.1% of patients, and all were mild in severity. This study identifies the factors associated with treatment satisfaction of avanafil, which may ultimately lead to better treatment outcomes. This is the first study to provide real-world evidence of avanafil for ED treatment, and validated questionnaires were used to assess erectile function and treatment satisfaction. However, the limitations of this study include single-center observational study design, small sample size, and short-term follow-up. Avanafil is an effective treatment for ED, and satisfaction rate is high in an outpatient setting. The awareness of identified factors related to patient satisfaction may improve treatment outcomes.

Magnetic resonance imaging-ultrasound fusion guided focal cryoablation for men with intermediate-risk prostate cancer

IntroductionFocal therapy (FT) is a form of ablative treatment offered to men with localized, organ-confined prostate cancer (CaP). Pelvic multiparametric magnetic resonance imaging (mpMRI) and mpMRI/transrectal ultrasound fusion (MRI-US) guidance enable the precise delivery of FT with limited ablation of adjacent benign tissue or vital genitourinary structures. This article presents our findings on using MRI-US to perform FT as a primary treatment for men with intermediate-risk CaP. MethodsThirty-six men underwent MRI-US fusion-guided FT cryoablation at a single center from 2018 to 2023 as a primary treatment for intermediate-risk CaP. Following FT, quarterly prostate-specific antigen (PSA) testing and a 6 to 9 month mpMRI and combined MRI-US targeted and systematic biopsy were performed. Oncological outcomes were determined using several endpoints containing biochemical recurrence, imaging failure, and pathological failure. Functional outcomes were measured using reported erectile dysfunction/potency rates, urinary incontinence rates, and the American Urologic Association Symptom Score (AUA-SS) and Sexual Health Inventory for Men (SHIM) indices. ResultsMedian follow-up was 29.1 months, most (75%) of whom had grade group 2 CaP. Out of the 36 men, 32 (88.9%) completed the combined MRI-targeted and systematic biopsy follow-up after treatment. The study had no major complications, but 12 (33.3%) patients experienced Clavien-Dindo grade II or lower complications. For oncological outcomes, 6 (16.7%) men had biochemical recurrence, 9 (25%) showed imaging failure, and 8 (22.2%) met the criteria for positive biopsy- out-of-field vs. in-field. 88.2% of previously potent patients remained potent postoperatively at 12 months. All patients were continent at 12 months. There were no statistically significant changes in the AUA-SS and SHIM scores postoperatively. ConclusionMRI-US-guided cryoablation to target lesions in intermediate-risk CaP appears to be a safe treatment option, with functional outcomes indicating minimal short and intermediate-term morbidity and acceptable oncological outcomes. However, despite close monitoring and follow-up, there is still a limitation in accurately predicting/detecting pathological failure after FT. The long-term durability of FT for intermediate-risk, organ-confined CaP remains uncertain.

Consumption of aphrodisiac drugs without prescription among men in Saudi Arabia: cross-sectional study

Background: The prevalence and patterns of aphrodisiac drug consumption without prescription among men in Saudi Arabia remain underexplored, with limited empirical evidence available. Given the potential health implications and societal considerations, a comprehensive investigation is warranted. Aim: Assess the Prevalence, pattern of use and the associated factors of Aphrodisiac drugs consumption without prescription among men at Najran City, Saudi Arabia. Methods: Employing a cross-sectional descriptive study, 500 participants were included through convenience sampling. The utilized questionnaires covered a range of data, including socio-demographic information, patterns of aphrodisiac use, knowledge about aphrodisiacs, lifestyle details, a sexual health inventory for men, and a perceived stress level scale. Results: The study reveals a significant prevalence of unsanctioned aphrodisiac drug use (31%) among men in Najran City, Saudi Arabia, with a majority (79.3%) consuming these substances four times monthly. Associated disparities in knowledge, lifestyle, stress, and sexual function underscore the urgent need for policy interventions and tailored health education initiatives for this demographic. Conclusion: Approximately one-third of the sampled population engaged in the unsanctioned use of aphrodisiac drugs, with the majority utilizing them four times monthly. Tablets emerged as the most prevalent form of consumption. Commonly cited motives and justifications included peer influence and the perceived safety of aphrodisiacs. Influential factors encompassed levels of knowledge, lifestyle, stress levels, erectile function, age, education, and the number of wives. Recommendations: Urgent policy interventions are warranted to regulate the acquisition and distribution of aphrodisiacs. Tailored health education initiatives should be implemented for married and prospective married men.

Saline-assisted fascial exposure (SAFE) technique to improve nerve-sparing in robot-assisted laparoscopic radical prostatectomy.

To provide a summary of our initial experience and assess the impact of the Saline-Assisted Fascial Exposure (SAFE) technique on erectile function (EF), urinary continence, and oncological outcomes after Robot-Assisted Laparoscopic Radical Prostatectomy (RALP). From January 2021 to July 2022, we included patients with a baseline Sexual Health Inventory for Men (SHIM) score of ≥17 and a high probability of extracapsular extension (ECE), ranging from 21% to 73%, as per the Martini etal. nomogram. A propensity score matching was carried out at a ratio of 1:2 between patients who underwent RALP + SAFE (33) and RALP alone (66). The descriptive statistical analysis is presented. The SAFE technique was performed using two approaches, transrectal guided by micro-ultrasound or transperitoneal. Its principle entails a low-pressure injection of saline solution in the periprostatic fascia to achieve an atraumatic dissection of the neural hammock. Potency was defined as a SHIM score of ≥17 and continence as no pads per day. At follow-up intervals of 6, 13, 26, and 52 weeks, the SHIM score differed significantly between the two groups, favouring the RALP + SAFE (P = 0.01, P < 0.001, P < 0.001, and P = 0.01, respectively). These results remained significant when the mean SHIM score was assessed. As shown by the cumulative incidence curve, EF rates were higher in the RALP + SAFE compared to the RALP alone group (log-rank P < 0.001). The baseline SHIM and use of the SAFE technique were independent predictors of EF recovery. The use of the SAFE technique led to better SHIM scores at 6, 13, 26, and 52 weeks after RALP in patients at high risk of ECE who underwent a partial NS procedure.

Serum albumin levels as a useful complementary marker for erectile dysfunction in ulcerative colitis: A cross-sectional study.

Recently, a close association between ulcerative colitis (UC) and erectile dysfunction (ED) was reported. An inverse relationship between serum albumin and ED is found in patients with chronic disease. However, the association between serum albumin levels and ED in patients with UC is unclear. This study aims to investigate this issue in Japanese patients with UC. One hundred and thirty-six Japanese male UC patients were enrolled in this study. Information on serum albumin levels and medications for UC from medical records, Sexual Health Inventory for Men (SHIM) score information from self-administered questionnaires and information on the severity of UC from physician reports were obtained from medical records, self-administered questionnaires, and reports from physicians. The participants were divided into tertiles based on the total protein, serum globulin, serum albumin, aspartate aminotransferase, and C-reactive protein levels. The definition of ED and severe ED was SHIM score < 22 and SHIM score < 8, respectively. The association between these serum markers and ED was assessed by multivariate logistic regression. The prevalence of severe ED in the low, moderate, and high albumin groups was 66.0%, 51.0%, and 28.3%, respectively. After adjusting for confounding factors, the low albumin group was independently and positively associated with severe ED (adjusted odds ratio: 2.74, 95% confidence interval: 1.03-7.48, p for trend =0.044). No association between other marker and ED was found. Serum albumin was independently inversely associated with severe ED in Japanese patients with UC. Hypoalbuminemia might be a useful complementary marker for assessing the prevalence and severity of ED in UC patients.

Sociodemographic and Clinical Correlates of Subjects Presenting with Complaint of Premature Ejaculation

Background: Premature ejaculation (PE) is a common sexual disorder. The profile of subjects seeking treatment of PE in India has not been reported earlier. Objective: To study the sociodemographic and clinical profile of subjects presenting with the complaint of PE. Material and Methods: The subjects presenting with the complaints of PE were recruited from a specialty psychosexual OPD in the department of psychiatry of a tertiary care center in North India. The subjects were assessed on semistructured proforma, MINI-International Neuropsychiatric Interview, version 7.0, the Diagnostic and Statistical Manual of Mental Disorders, Premature Ejaculation Diagnostic Tool, Arizona Sexual Experience Scale, Hamilton Rating Scale for Depression, and Hamilton Rating Scale Anxiety, Sexual Health Inventory for Men, and Short Form-36 Health Questionnaire. Results: A total of 102 subjects were selected after screening 148 cases attending OPD with the complaints of PE after applying selection criteria. The mean age of the sample was 32.17 years (± 8.11). Most of the subjects were married (80.4%), cohabitating with partners (70.6%) and living in the rural area (53.9%). The mean age of onset was 28.29 years (± 7.83, range 17–53), and the mean duration of illness was 3.87 years (± 5.49, range 0.5–31). Prevalence of sexual, psychiatric, and medical comorbidities was 60.8%, 16.7%, and 29.5%, respectively. Emotional role functioning, energy, and general health were the most adversely affected domains of health-related quality of life. Conclusion: Most of the men in this study of PE subjects seeking treatment were married young adults. The individuals typically had moderate to severe PE. Comorbidities are prevalent, and roughly two-thirds of people have another medical, psychiatric, or sexual dysfunction.

Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial

Abstract Background Low-intensity shockwave therapy for erectile dysfunction is emerging as a promising treatment option. Aim This randomized sham-controlled crossover trial assessed the efficacy of low-intensity shockwave therapy in the treatment of erectile dysfunction. Methods Thirty-three participants with organic erectile dysfunction were enrolled and randomized to shockwave therapy (n = 17) or sham (n = 16). The sham group was allowed to cross over to receive shockwave therapy after 1 month. Outcomes Primary outcomes were the changes in Sexual Health Inventory for Men (SHIM) score and Erection Hardness Score at 1 month following shockwave therapy vs sham, and secondary outcomes were erectile function measurements at 1, 3, and 6 months following shockwave therapy. Results At 1 month, mean SHIM scores were significantly increased in the shockwave therapy arm as compared with the sham arm (+3.0 vs −0.7, P = .024). Participants at 6 months posttreatment (n = 33) showed a mean increase of 5.5 points vs baseline (P &amp;lt; .001), with 20 (54.6%) having an increase ≥5. Of the 25 men with an initial Erection Hardness Score &amp;lt;3, 68% improved to a score ≥3 at 6 months. When compared with baseline, the entire cohort demonstrated significant increases in erectile function outcomes at 1, 3, and 6 months after treatment. Clinical Implications In this randomized sham-controlled crossover trial, we showed that 54.6% of participants with organic erectile dysfunction met the minimal clinically important difference in SHIM scores after treatment with low-intensity shockwave therapy. Strengths and Limitations Strengths of this study include a sham-controlled group that crossed over to treatment. Limitations include a modest sample size at a single institution. Conclusions Low-intensity shockwave therapy improves erectile function in men with erectile dysfunction as compared with sham treatment, which persists even 6 months after treatment. Clinical Trial Registration ClinicalTrials.gov NCT04434352.