Sexual Health Inventory Research Articles

Penile constriction devices: a randomized survey study to compare preferences between two medical-grade devices.

Penile constriction devices offer a noninvasive approach to enhance the sexual experience and as the variety of penile constriction devices increases, it is crucial to assess patient preferences and device effectiveness to provide insights into their clinical utility. We aimed to compare the preferences for and effectiveness of two medical-grade penile constriction devices: Eddie by Giddy and FirmTech. Between May and July of 2023, males were recruited via social media and prospectively enrolled into an Institutional Review Board-approved, randomized, questionnaire-based study. Upon enrollment, the participants completed the Sexual Health Inventory for Men and Androgen Deficiency in Aging Males questionnaires. Participants were randomized to which device they received first. They used the device twice either during masturbation or intercourse in a two-week timeframe. Once utilized, the participants completed a 17-question, Likert scale, device satisfaction questionnaire, in which lower numbers indicated positive responses. The process was repeated with the second device. T-test and Chi-Square Analysis were run for statistical analysis. The primary outcomes of this study were patient-reported device satisfaction and efficacy and the secondary outcome was the device preference for patients with and without erectile dysfunction. Fifty men were enrolled and 49 completed the study. The average age was 40years old. Of the participants, 80% recommend the FirmTech device compared to 53% who recommend the Eddie by Giddy device (P= 0.0026). The FirmTech device was overall easier to put on both flaccid and erect (P= 0.0308 and 0.0002), was more comfortable, had better stretch, and was easier to adjust (P= 0.087, <0.0001, and 0.0119, respectively). The FirmTech device had a better overall impression amongst the participants (P= 0.0249). Eddie by Giddy was felt to improve erectile firmness more in those with ED than in those without (P = 0.0178). This study adds to the current literature on penile constriction devices that better guide providers as they counsel patients on these devices to enhance sexual function. The strength of this study is that this is a prospective randomized crossover study. The limitations of this study are that this is a single center study based on patient reported outcomes. The FirmTech device performed better than the Eddie by Giddy with respect to overall impression of the device, likelihood of using the device in the future, and recommending the device to a friend, while the Eddie by Giddy device performed better at improving erectile firmness. NCT05853822.

Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?-long-term outcomes of a randomized sham-controlled trial.

Low-intensity shockwave therapy (LiSWT) is an emerging non-invasive and restorative therapy for erectile dysfunction (ED) with demonstrated efficacy and few adverse events. Although LiSWT has been shown to improve erectile function amongst men with ED, few studies have examined its long-term durability. We present the long-term results of a randomized controlled trial (RCT) assessing erectile function after LiSWT. A total of 30 patients with baseline ED seen at the University of Virginia were randomized to LiSWT or sham treatment. Patients in the sham group crossed over at 1 month and were unblinded. After initial trial completion, patients enrolled in the long-term outcome study were considered one combined cohort. Patients were treated twice weekly for 3 consecutive weeks with a Storz® Duolith™ device delivering 3,000 shockwaves at 0.1 mJ/mm2 to the distal penis, the base of the penis, and the crura. Primary outcomes were changes in Sexual Health Inventory for Men (SHIM) and Erection Hardness Score (EHS) from baseline (3 months pre-treatment) up to 36 months post-treatment. Changes in SHIM and EHS scores were evaluated using linear mixed effects models. Patient satisfaction was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index. The mean baseline SHIM score was 10.8±0.94. At 12-, 24-, and 36-month assessment following treatment, the mean SHIM scores were 15.6±1.27 (P<0.001), 15.0±1.14 (P<0.001), and 12.2±1.43 (P=0.31). The mean baseline EHS score was 1.87±0.17. At 12-, 24-, and 36-month assessment following treatment, the mean EHSs were 2.70±0.24 (P<0.001), 2.66±0.21 (P<0.001), and 2.29±0.26 (P=0.10). The median [interquartile range (IQR)] EDITS score was 48.9 (22.7, 74.4), indicating moderate satisfaction with LiSWT. There were no adverse events recorded. Our analysis demonstrates sustained long-term improvement in erectile function after LiSWT for a heterogeneous cohort. While limited by population size, the results suggest durable improvement in erectile function for the first 2 years with a peak treatment effect at 1 year. Treatment effect appears to decline between 2 and 3 years. ClinicalTrials.gov, NCT04434352.

Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study

PurposeTo describe clinical outcomes among patients with benign prostatic hyperplasia (BPH) 24 months following prostatic artery embolization (PAE).Materials and MethodsThis was an international, multicenter, prospective trial of males with BPH with lower urinary tract symptoms (LUTS) or acute urinary retention (AUR) treated with PAE. The primary outcome was the 12 month change in the International Prostate Symptom Score (IPSS) for patients referred for bothersome LUTS, or urinary catheter independence for patients treated for AUR. Secondary outcome measures included changes in IPSS at 3 and 24 months, changes in quality of life (QoL), changes in the Sexual Health Inventory for Men (SHIM) questionnaire, technical success rate, and adverse events (AEs). Data were summarized using descriptive statistics.ResultsFour hundred seventy-eight consecutive patients underwent PAE (bothersome LUTS: N = 405; AUR: N = 73), mean age was 70 years. For patients treated for bothersome LUTS, mean total IPSS at baseline was 21.8 and decreased to 9.3, 10.6, and 11.2 at 3, 12, and 24 months following PAE, respectively (all p < 0.001); QoL at baseline was 4.7 and decreased to 2.0, 2.1, and 2.3 at 3, 12, and 24 months, respectively (all p < 0.001). The mean SHIM score at baseline and 12 months following PAE was 13.8 and 13.9, respectively. Of the 73 patients treated for AUR, 48 (65.8%) had their indwelling catheter removed within 3 months of PAE and remained catheter free at 24 months. Fifty-five patients (11.5%) experienced ≥ 1 AE and 10 (2.1%) experienced a serious AE.ConclusionPAE is a safe and effective treatment for symptomatic BPH and LUTS.Level of Evidence Level 3Trial registration ClinicalTrials.gov NCT03527589.Graphical

Trifecta Outcomes After Use of 3-Dimensional Digital Models for Planning of Robotic Prostatectomy

Planning complex operations such as robotic-assisted laparoscopic radical prostatectomy (RALP) requires surgeons to review 2-dimensional magnetic resonance imaging (MRI) scans to understand 3-dimensional (3D) patient anatomy. Three-dimensional digital models for planning RALP may allow better understanding of patient anatomy and may lead to better patient outcomes, although data are currently limited. To determine surgical outcomes after RALP when surgeons reviewed 3D digital models during operative planning. This study was a planned secondary analysis of a multicenter, single-blind, randomized clinical trial conducted at 6 large teaching hospitals in the US. The study was conducted between January 1, 2019, and December 31, 2022, and included patients undergoing RALP. Patients were assessed and recruited at the time of surgical consultation. Final data analysis was conducted between August and December 2023. Patients were randomized to either a control group undergoing usual preoperative planning with prostate biopsy results and multiparametric MRI only or to an intervention group in which imaging and biopsy results were supplemented with a 3D digital model. This model was viewed on the surgeon's mobile phone in 3D format and picture-in-picture on the robotic console screen. The primary outcome measure for the overall study was oncologic outcomes after RALP, measured as prostate-specific antigen (PSA) detectability. Secondary outcomes were sexual function and urinary function, measured with Sexual Health Inventory for Men (SHIM) scores and rates of urinary incontinence, respectively, as well as use of salvage or adjuvant radiation therapy (RT) or androgen deprivation therapy (ADT). Trifecta outcomes were defined as undetectable PSA without RT or ADT, SHIM score categorically the same or greater than preoperatively, and complete continence. Univariate analysis was performed to compare outcomes between groups. This trial included 92 patients undergoing RALP (51 in the control group and 41 in the intervention group). Their mean (SD) age was 62 (7.4) years; 10 patients (10.9%) were Black and 67 (72.8%) were White. At 18 months postsurgery, the intervention group had lower rates of biochemical recurrence (PSA level >0.1 ng/mL, 0 vs 7 [17.9%]; absolute difference, 17.9% [95% CI, 1.8% to 31.8%]; P = .01) and were significantly less likely to undergo adjuvant or salvage RT (1 [3.1%] vs 12 [31.6%]; absolute difference, 28.5% [95% CI, 10.1% to 46.7%]; P = .002) compared with the control group. Sexual function at 18 months postsurgery was significantly better in the intervention group (mean [SD] SHIM score, 16.8 [8.7] vs 9.8 [7.7]; absolute difference, 7.0 [95% CI, 2.6 to 11.4]; P = .002) and urinary function was unchanged (total continence, 22 [78.6%] vs 29 [80.6%]; absolute difference, 2.0% [95% CI, -17.9% to 21.9%]; P = .84) compared with the control group. Trifecta outcomes were achieved for 12 (48.0%) patients in the intervention group and 3 patients (10.0%) in the control group (absolute difference, 38.0% [95% CI, 14.4% to 61.6%]; P = .002). In this secondary analysis of a randomized clinical trial, patients whose surgical planning of RALP involved 3D digital models had better oncologic and functional outcomes. Further work should assess the effect of 3D models in a broader set of patients, physicians, and hospital settings. ClinicalTrials.gov Identifier: NCT03943368.

MRI-guided transrectal prostate laser ablation for benign prostatic hypertrophy: a retrospective cohort study.

To investigate whether MRI-guided transrectal laser ablation is safe and effective for the treatment of lower urinary tract symptoms caused by BPH. This single-center retrospective cohort study evaluated men who underwent MRI-guided transrectal laser ablation for BPH between February 2017 and July 2021. Age, prostate-specific antigen, prostate volume, prior surgical BPH treatments if any, International Prostate Symptom Score (IPSS) and Sexual Health Inventory of Men (SHIM) were collected. The primary outcome measures assessed were change in IPSS and SHIM 6, 12 and 24 months after laser ablation and adverse events. Fifty-two patients were included, having completed at least one follow-up survey. The mean patient age was 62.9 ± 5.7 years, and mean prostate volume was 80.2 ± 39.2 cc. Eighteen patients (34.6%) had received a prior BPH treatment. The IPSS scores dropped an average of 16.7 ± 7.0 (p < 0.001), 16.9 ± 7.5 (p < 0.001) and 17.1 ± 7.2 (p < 0.001) points from baseline at 6, 12 and 24 months, respectively. There was no statistically significant difference in IPSS score drop between patients who had received a prior BPH procedure and those who had not (p = 0.628). The SHIM scores showed a statistically insignificant increase at all time points. Nineteen patients (36.5%) reported a complication. There were 12 grade II complications (23%) and seven grade I complications (13.5%). There were no grade III or higher complications. Transrectal MRI-guided focal laser ablation is safe and effective for the treatment of lower urinary tract symptoms caused by BPH, with a significant improvement in symptom severity after 2 years.

Erectile Function and Sexual Activity Are Declining in the Younger Generation: Results from a National Survey in Japan.

Twenty five years have passed since the first national survey on erectile dysfunction (ED) in Japan. The Japanese Society for Sexual Medicine conducted a nationwide survey on the actual status of sexual function targeting men over 20 years old in Japan using validated questionnaires commonly used in clinical practice. Japanese men aged 20 to 79 years participated in our online epidemiological study on sexual dysfunction. Erectile status was assessed by direct questioning and specific questionnaires. Risk factors and frequencies of sexual intercourse, masturbation, nocturnal erections, and feeling sexual desire were assessed. The prevalence of these risk factors was compared between men with and without ED. Prevalence and frequencies were calculated for each 5-year age group. Main outcomes were the prevalence and number of patients with ED and simultaneous evaluation of age-related variations. Direct questioning of the men revealed that 13.0% felt troubled by ED. Although 81.0% of them had at least some ED symptoms based on a Sexual Health Inventory For Men score of ≤21, the prevalence of men with ED by Erection Hardness Score (EHS), the most appropriate questionnaire for Japanese with low sexual activity, was 30.9%, indicating that 14,012,596 men have ED. Most risk factors were related with ED, whereas frequencies of sexual intercourse, masturbation, nocturnal erections, and feeling sexual desire were affected by aging. However, the low frequency of these factors in the young generation was surprising. The EHS-based assessment revealed a prevalence of ED of 30.9%, which affected approximately 14 million men, and that the sexual desire, erection stiffness, orgasms, and satisfaction were lower than expected in young Japanese men, especially those aged 20 to 24 years, although those factors tended to worsen with aging. We believe that these findings actually reveal the current sexual status of men in Japan.

Single-Port Extraperitoneal vs. Multiport Transperitoneal Robot-Assisted Radical Prostatectomy: A Propensity Score-Matched Analysis.

(1) Background: Since the introduction of the purpose-built Single Port (SP) robotic platform, there has been an ongoing debate regarding its advantages compared to the established multi-port (MP) system. The goal of this present study is to compare the perioperative, oncological, and functional outcomes of SP Extraperitoneal robotic radical prostatectomy (RARP) versus that of MP Transperitoneal RARP approach at a high-volume tertiary center. (2) Methods: Based on a retrospective review of the prospectively maintained IRB-approved database, 925 patients successfully underwent RARP by a single experienced robotic surgeon. A 4:1 propensity-matched analysis based on the baseline prostate cancer International Society of Urological Pathology (ISUP) Grade Group, clinical stage, and preoperative Prostate Specific Antigen (PSA) was performed, which yielded a cohort of 606 patients-485 in the SP EP and 121 in the MP TP approaches. Of note, the SP EP approach also included the traditional Extraperitoneal (n = 259, 53.4%) and the novel Transvesical (TV) approaches (n = 226, 46.6%). (3) Results: The overall operative time was slightly longer in the SP cohort, with a mean of 198.9 min compared to 181.5 min for the MP group (p < 0.001). There were no intraoperative complications with the MP approach and only one during the SP approach. The SP EP technique demonstrated significant benefits, encompassing reduced intraoperative blood loss (SP 125.1 vs. MP 215.9 mL), shorter length of hospital stay (SP 12.6 vs. MP 31.9 h), reduced opioid use at the time of discharge (SP 14.4% vs. MP 85.1%), and an earlier Foley catheter removal (SP 6 vs. MP 8 days). From an oncological perspective, the rate of positive surgical margins remained comparable across both groups (p = 0.84). Regarding functional outcomes, the mean continence rates and Sexual Health Inventory for Men (SHIM) scores were identical between the two groups at 6 weeks, 3 months, and 6 months respectively. (4) Conclusion: SP EP RARP demonstrates similar performance to MP TP RARP in terms of oncologic and functional outcomes. However, SP EP RARP offers several advantages in reducing the overall hospital stay, decreasing postoperative pain and hence the overall opioid use, as well as shortening the time to catheter removal, all of which translates to reduced morbidity and facilitates the transition to outpatient surgery.

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.

(010) ERECTION FUNCTION AND BOTHER IN TRANSGENDER WOMEN TAKING GENDER AFFIRMING HORMONE THERAPY AND AFTER PRE-VAGINOPLASTY BILATERAL ORCHIECTOMY

Abstract Introduction Gender-affirming (GA) hormone therapy (GAHT) and bilateral orchiectomy (GABO) significantly reduce gender dysphoria in transgender women (TW). A key source of dysphoria is penile erection. To date, no studies have described erectile function (EF) among TW taking GAHT and after GABO. Objective We aimed to: 1) Evaluate EF among two cohorts of TW before vaginoplasty: One taking only GAHT &amp;gt;6mo., and the other taking GAHT &amp; &amp;gt;6 months post-GABO). 2) Determine the incidence of erections among these cohorts based on whether they do or do not use their penis for sexual activity 3) Query subjects’ interest for any treatment that could eliminate penile erections before vaginoplasty. Methods Pre-vaginoplasty TW on GAHT were surveyed anonymously. Participants were grouped based on GABO status. We queried EF using the Sexual Health Inventory for Men (SHIM) questionnaire at three points (pre-GAHT, &amp;gt;6 months after starting GAHT, and &amp;gt;6 months post-GABO). We also queried the incidence of any erections in these three states, and, whether patients would undergo a procedure that promised to reduce or eliminate erections. Results 31 participants participated (16 GAHT-only; 15 GAHT+GABO). Median age was 37 years (IQR 25.3 Y) and median years on GAHT was 5.5 years (IQR 7.3 Y). 21/31 (68%) reported they do not use their penis for sexual activity. TW on GAHT and GAHT+GABO showed reduced SHIM score, with lowest scores in TW who did not use their penis during sex (Figure 1a). Spontaneous erections were reduced for women who did not use their penis during sex in the GAHT+GABO group, vs. the GAHT-only group, but both groups reported high incidence of erections with arousal and during sex (b). Most TW showed a high interest in any procedure that promised to completely eliminate their erections (c). Conclusions Our study is the first to show that GAHT reduces SHIM scores, but the greatest reduction is in TW who do not use their penis for sexual activity. While GABO significantly reduces spontaneous erections vs. GAHT alone, neither appears to have much effect on erections with sexual arousal or sexual activity. The majority of women reported significant dislike &amp; dysphoria from their erections, and would choose to undergo any reasonable procedure that completely eliminated, or at least reduced, their erections. Further study with larger numbers is warranted. Disclosure No.

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.

Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial.

Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their postoperative outcomes in a randomized setting. In a single center, 354 men with newly diagnosed prostate cancer were assessed for eligibility; 342 were randomized (1:1). The primary outcome was 90-day complication rates. Functional outcomes and quality of life were assessed over 18 months, and oncological outcomes, biochemical recurrence-free survival, and additional treatment over 36 months. From 2014 to 18, 327 patients underwent surgery (retropubic radical prostatectomy = 156, RALP = 171). Complications occurred in 27 (17.3%) vs 19 (11.1%; P = .107). Patients undergoing RALP experienced lower median bleeding (250.0 vs 719.5 mL; P < .001) and shorter hospitalization time. Urinary EPIC (Expanded Prostate Cancer Index Composite) median scores were better for RALP over 18 months, with higher continence rate at 3 months (80.5% vs 64.7%; P = .002), 6 months (90.1% vs 81.6%; P = .036) and 18 months (95.4% vs 78.8%; P < .001). Sexual EPIC and Sexual Health Inventory for Men median scores were higher with RALP up to 12 months, while the potency rate was superior at 3 months (23.9% vs 5.3%; P = .001) and 6 months (30.6% vs 6.9%; P < .001). Quality of life over the 18 months and oncological outcomes over 36 months were not significantly different between arms. Complications at 90 days were similar. RALP showed superior sexual outcomes at 1 year, improved urinary outcomes at 18 months, and comparable oncological outcomes at 36 months. Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.

Association Between Socioeconomic Status and Erectile Dysfunction in Japanese Patients With Ulcerative Colitis: A Cross-Sectional Study.

Socioeconomic status is a risk factor for poor disease prognosis. No studies of patients with ulcerative colitis (UC) have investigated the association between socioeconomic status and erectile dysfunction (ED), although UC is independently positively associated with ED. Therefore, the purpose of this survey to evaluate this issue in Japanese patients with UC. The study enrolled 165 patients with UC. Education status (low, middle, high) and household income (low, middle, high) were classified in three groups using self-administered surveys. The information regarding the Sexual Health Inventory for Men (SHIM) was obtained using self-administered questionnaires. The definition of mild to moderate or severe ED and severe ED was SHIM score <17 and SHIM score <8, respectively. The prevalence of mild to moderate or severe ED and severe ED was 64.9% and 47.9%, respectively. In crude analysis, household income was inversely associated with mild to moderate or severe ED and severe ED. After adjustment for age, current drinking, current smoking, exercise habit, body mass index, mucosal healing, and duration of UC, high household income was independently and inversely associated with mild to moderate or severe ED (adjusted odds ratio [OR] 0.23, 95% confidence interval [CI] [0.05, 0.93], p for trend = .038) and severe ED (adjusted OR 0.26, 95% CI [0.07, 0.85], p for trend = .024). In contrast, no association between education status and ED was found. In conclusion, household income was independently and inversely associated with ED in Japanese UC patients.

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.

Association between bowel movement frequency and erectile dysfunction in patients with ulcerative colitis: a cross-sectional study.

The association between ulcerative colitis (UC) and erectile dysfunction (ED) has been previously reported. Numerous previous studies have also reported an association between gastrointestinal symptoms and ED. Constipation and diarrhea are common in patients with UC. However, the specific association between bowel movement frequency and ED remains unclear. The aim of this study is to investigate the association between bowel movement frequency and ED in 164 patients with UC. The definition of ED, moderate to severe ED, and severe ED was the Sexual Health Inventory for Men score <22, <12, and <8, respectively. Bowel movement frequency was divided into three categories: (1) high (More than once a day), (2) normal (once a day, reference), and low (less than one time/day). The definition of constipation was based on the Rome I criteria and/or medication for constipation. The prevalence of constipation and ED was 10.4% and 86.0%, respectively. The rate of high, normal, and low bowel movement frequency was 56.1%, 25.0%, and 18.9%, respectively. High bowel movement frequency was independently and positively associated with ED and moderate to severe ED (ED: adjusted odds ratio [OR] 4.42, 95% confidence interval [CI] 1.35-15.98; moderate to severe: adjusted OR 2.98, 95% CI 1.22-7.61). Low bowel movement frequency was independently and positively associated with moderate to severe ED and severe ED (moderate to severe: adjusted OR 3.96, 95% CI 1.27-13.08; severe: adjusted OR 3.20, 95% CI 1.08-9.86). No association between constipation and ED was found. In conclusion, in Japanese patients with UC, both high and low bowel movement frequency were independently and positively associated with ED.

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.

(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.

(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.