Changes In Erectile Function Research Articles

(138) EFFICACY OF A NOVEL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM PROTOCOL FOR PEYRONIE’S DISEASE AMONG PRIOR NON-RESPONDERS: A RANDOMIZED, CONTROLLED, SINGLE-BLINDED STUDY

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We sought to evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Objective To evaluate whether additional rounds of CCH using a novel protocol in men previously unresponsive results in greater curve improvements. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 38/40 men have been randomized to date, with 22 having fully completed treatment. Mean age was 57 years, with a median PD duration of 22 months. Median composite baseline curvature was 65 degrees, with 40% having hourglass or indentation deformities, 8% calcification, median baseline IIEF-EFD 20, and 58% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 18.8), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (58% vs 35% satisfied, 8% neutral). Of the 22 men who had completed the study protocol, 50% required 1 series, 14% 2 series, 29% 3 series, and 7% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (median 60 degrees vs 0, p = 0.01). IIEF-EFD was non-statistically higher in treated men (0 vs -5, p = 0.17). 92% of men reported a subjective major improvement in curvature, with the median subjectively estimated improvement 90%. 42% reported improved sensitivity (58% no change), while 63% reported improved or no change in erectile function, with 9% unsure, and 27% worse. Post-treatment, 92% of men were very satisfied with CCH as a treatment and 8% neutral. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.

The Role of Pelvic Floor Muscle Exercise in Erectile Dysfunction

PURPOSE: This study aimed to determine the role or applicability of pelvic floor muscle exercise for erectile dysfunction.METHODS: This narrative review was conducted by searching terms such as “erectile dysfunction”, “erection dysfunction”, “sexual dysfunction”, and “pelvic floor muscle training”, “pelvic floor muscle exercise”, “pelvic floor exercise”, “randomized controlled trials”, “randomized clinical trials” in PubMed, Google Scholar, Scopus, and Web of Science.RESULTS: Seven articles met the inclusion criteria. Six studies applied pelvic floor muscle exercise, electrical stimulation, and biofeedback treatment to patients with erectile dysfunction after radical prostatectomy. Only three studies showed that treatment in the intervention group had a significant effect on erectile function. Considering these results, the study subjects who applied the three treatment methods presented above were mainly patients with erectile dysfunction caused by prostate cancer surgery.CONCLUSIONS: Seven randomized controlled trials showed no significant effect of pelvic floor muscle exercise on erectile dysfunction. However, they are thought to have applicability as a method for treating erectile dysfunction. In studies of erectile dysfunction caused by radical prostatectomy, homogeneity in the age, duration of erectile dysfunction, and nerve-sparing surgery should be ensured between the intervention and control groups. First, future clinical research is required to determine whether existing methods and concurrent treatment with drugs, such as sildenafil (Viagra) and tadalafil (Cialis) can shorten the recovery period of erectile function. Second, clinical research is needed to analyze the differences in changes in erectile function between those performing aerobic exercise and pelvic floor muscle exercise combined and those performing only pelvic floor muscle exercise.

(193) EPIDEMIOLOGICAL CHARACTERISTICS OF ERECTILE DYSFUNCTION IN THE BRAZILIAN POPULATION: A CROSS-SECTIONAL STUDY

Abstract Introduction Erectile dysfunction (ED) is a common symptom among men with cardiovascular diseases and various disorders, including hypogonadism, Peyronie’s disease, priapism, neuralgic disorders, and depression, as reported by the American Institute of Health. The presence of these conditions serves as risk factors for the development of ED, prompting men to seek medical attention when they detect changes in erectile function, thereby signaling potential underlying health issues. Understanding the link between these conditions and ED is crucial for effective management and intervention. Objective This study aims to investigate the epidemiological profile of men diagnosed with erectile dysfunction. Methods A retrospective cross-sectional analysis was conducted on patients with erectile dysfunction attending the andrology outpatient clinic at a university hospital. Sociodemographic information, comorbidity profiles, lifestyle habits, addictive behaviors, and other sexual concerns were assessed through a structured questionnaire. The association between sociodemographic variables and comorbidities was evaluated using Fisher’s exact test, with statistical significance set at p < 0.05, and analyzed using the Stata® software. Results A total of 654 patients were included in the study, with a mean age of 61.46 ± 12.01 years, and 63.5% of participants aged ≥60 years. The racial distribution showed that 54.6% were white (357/654) and 32.2% were brown (211/654) individuals. Among them, 68.3% (447/654) were married, and 50.9% (333/654) had not completed elementary education. The most prevalent comorbidities were Systemic Arterial Hypertension (51%, 333/654) and Diabetes Mellitus (32.7%, 214/654). Regarding lifestyle habits, 77.1% (504/654) did not use any drugs, while 16.7% (109/654) were smokers. Additionally, 80 patients reported concurrent sexual dysfunctions, with premature ejaculation (33%, 26/80) and Peyronie’s disease (25%, 20/80) being the most common. Smoking was found to have a significant association with ED (p-value = 0.03), whereas no other statistically significant associations were observed in the analyzed variables. Conclusions This study highlights that individuals with ED in this population tend to be predominantly white or brown, married, and with lower educational attainment. Systemic Arterial Hypertension and Diabetes Mellitus were the leading comorbidities, and smoking showed a significant association with ED. These findings underscore the importance of comprehensive assessment and management strategies for ED patients, taking into account their sociodemographic and lifestyle factors. Disclosure No.

The neurological decline and psychological factors caused by coronavirus disease 2019 may be predictors of erectile dysfunction.

Since the outbreak of coronavirus disease 2019, it has had a serious impact on people's physical and mental health. However, in our clinical work, we have found that the erectile function of coronavirus disease 2019 patients with neurological decline was often seriously affected. To further explore the relationship between erectile dysfunction and neurological dysfunction caused by coronavirus disease 2019. We conducted a survey from August 2022 to February 2023 at the First Affiliated Hospital of Anhui Medical University and the Third People's Hospital of Linyi City. A total of 251 subjects with a history of coronavirus disease 2019 infection were included. Symptoms and changes in erectile function after the coronavirus disease 2019 infection were collected and assessed using the International Index of Erectile Function-5 scale and several targeted questions. In this study, we found that in patients infected with novel coronavirus, the proportion of erectile dysfunction was higher in those with neurological manifestations such as olfactory and taste impairment or psychological symptoms such as anxiety. We found that neurological decline and psychological factors were independent and significant risk factors for erectile dysfunction caused by coronavirus disease 2019. Patients with neurological damage or psychiatric symptoms are more likely to have erectile dysfunction, suggesting that the 2019 novel coronavirus may affect erectile function by damaging nerves. This provides a new insight into the mechanism of erectile dysfunction.

(155) The Erectile Restoration Registry: It MATTERS

Abstract Introduction Treatment methodology for erectile dysfunction can vary from surgeon to surgeon. The It MATTERS registry has been developed to align prospective, long-term, real-world outcomes with current clinical practice. It MATTERS is an immediate avenue (following market approval of a product) to collect and monitor real-world data on existing and future innovation, with respect to Boston Scientific’s penile prostheses (2- and 3-piece inflatable, and malleable), Rear Tip Extenders, surgical tools (sterile and non-sterile), accessories, kits, and all included components. This includes, but is not limited to, the Furlow Insertion Tool, Disposable Dilators, Sizers, Insertion Package (tubing passers), Proximal Tool, Quick Connect Assembly Tool, AMS Closing Tool, and the Deactivation Package. Objective Description of a real-world registry that evaluates erectile function, post-penile prosthesis implantation, over time. Methods It MATTERS is a single-arm, prospective, multi-center registry with follow-up occurring post-surgery and at 6 months, 12 months, and annually, thereafter. Subjects will serve as their own control; follow-up assessments will be compared to values collected at baseline. The registry is designed to capture the wide array of immediate, post-surgery follow-up schedules without dictating a specific visit cadence. Following signature of an informed consent, eligible subjects are treated with a Boston Scientific penile prosthesis. The registry will enroll over the lifetime of each device, allowing for up to 150 active subjects in follow-up, per device. Results Registry endpoints include measuring change in erectile function from baseline using the Erectile Function domain of the International Index of Erectile Function (IIEF-EF), change in depressive symptoms using the Patient Health Questionnaire (PHQ)-9, overall sexual function using the IIEF Total Score, and change in work productivity using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). Additional measures, amongst many, include patient-reported device satisfaction using a 5-point Likert scale and adverse events. For each penile prothesis group in the registry, a two-sided 95% confidence interval may be constructed for interpreting the change in IIEF-EF score over time compared to baseline. Descriptive statistics will summarize continuous and categorical variables. Currently, 51 penile prosthesis implants have been completed: Tactra™ Malleable Penile Prosthesis (n = 34), Spectra™ Concealable Penile Prosthesis (n = 9), and AMS Ambicor™ Inflatable Penile Prosthesis (2-piece; n = 8). Conclusions The It MATTERS registry builds on over 50 years of erectile dysfunction patient care and data. It will allow for the comparison of outcomes and clinical practice on legacy and new market-approved products, which will pave the way for future innovation and advancing patient care. Disclosure Yes, this is sponsored by industry/sponsor: Industry initiated, executed, and funded registry. All authors act as consultants, employees, or shareholders of Boston Scientific Corporation. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific Corporation.

(371) Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie’s Disease: A Randomized Trial – 1 Year Outcomes

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We have previously published results comparing the two therapies at 3-months post-treatment. Objective To compare various objective and subjective outcome measures at 12-months post-treatment between men undergoing CCH or surgery for PD. Methods A randomized, controlled trial (NCT04786106) is ongoing. Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments were obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature was measured in two planes and summed to provide a composite curvature. Penile length was measured from pubic symphysis to corona. All adjunctive therapies were stopped at 3-months post treatment completion (i.e., traction and sildenafil). Results A total of 40 men were randomized, with 38 completing treatment and 12-month data available on 28 men (CCH=12, surgery=16). Mean age at enrollment was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding primary outcomes, at 12-months post-treatment, CCH men reported being very satisfied 36%, satisfied 27%, and neutral 36% with none dissatisfied. Men in the Surgery cohort reported 14% very satisfied, 64% satisfied, 0% neutral, and 21% dissatisfied (p<0.01). For secondary outcomes, the median differences between CCH and Surgery were: IIEF-EFD (+2.0 vs +2.0, p=0.82), PDQ-physical (-5 vs -5, p=0.77, note, lower is better for PDQ scales), PDQ-pain (-1 vs 0, p=0.92), PDQ-bother (-7 vs -3, p=0.12), length change (+1.0 vs -0.13 cm, p<0.05), curvature absolute change (-37.5 vs -53.8 degrees, p=0.17), and curvature % improvement (55% vs 82%, p=0.15). Compared to 3-month data, Surgery men experienced greater curve recurrence (objective: Surgery +5 degrees vs -5 degrees CCH, p<0.05), decreased subjective penile length 62% vs 9% CCH (p<0.01) and decreased sensitivity (54% vs 27% CCH, p<0.05). Both groups reported similar rates of improved sexual function (CCH 82% vs 64%, p=0.30) and change in erectile function (CCH 55% improved, 9% worsened; Surgery 62% improved, 8% worsened, p=0.53). Both groups were also equally satisfied with their curvature (CCH 55% vs Surgery 54%, p=0.97), despite greater overall curve improvements in the Surgery arm. 75% of CCH men reported improved indentation/hourglass vs 56% Surgery, p<0.05. Both groups reported similar rates of being willing to do their treatment again (CCH 73% vs 77%, p=0.64), while 91% of CCH men would recommend it to a friend vs 77% Surgery (p=0.35). Conclusions Preliminary data suggests that when compared to surgery at 12-months, CCH men were more likely to be very satisfied, experience penile length increases, and less likely to experience dissatisfaction, curvature recurrence, and decreased penile sensation. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.

(210) Four-Year Surgical and Sexual Function Outcomes of Rezum Therapy Across a Broad Range of Prostate Volumes

Abstract Introduction Benign prostatic hyperplasia (BPH) often leads to the development of lower urinary tract symptoms (LUTS), which can result in significant deterioration in quality of life (QoL). Rezum therapy has demonstrated efficacy in alleviating LUTS secondary to BPH across a broad range of prostate volumes (PVs). However, there is a scarcity of long-term real-world data on Rezum outcomes across a wide range of PVs. Objective To evaluate surgical and sexual function Rezum outcomes over a 4-year period in patients with PVs <30cc, 30-80cc, or >80cc. Methods A retrospective study was conducted on patients from a multiethnic population treated with Rezum between 2017 and 2019. Patients were stratified into three cohorts based on PV: <30cc, 30-80cc, or >80cc. Outcome measures, including International Prostate Symptom Score (IPSS), QoL, International Index of Erectile Function (IIEF)-Erectile and Orgasmic function, maximum urinary flow rate (Qmax), BPH medication usage, adverse events (AEs), and decisional regret scores were collected and compared at baseline and 1-, 3-, 6-, 12-, and/or 48-months follow-up. Results A total of 252 patients were analyzed, with 35 (13.9%), 196 (77.8%), and 21 (8.3%) patients in the 30cc, 30-80cc, and >80cc cohorts, respectively. The >80cc cohort was significantly older (66.9 years [8.1]) than the <30cc cohort (63.4 years [8.5], p = 0.02). The <30cc cohort had a significantly higher baseline IPSS (21 [15-28]) and QoL (5 [4-6]) than the 30-80cc (IPSS 17 [10-23], p = 0.003; QoL 4 [3-5], p=0.02) and >80cc (IPSS 16 [6.5-22.5], p = 0.01; QoL 4 [3-5], p = 0.006) cohorts. The number of injections utilized per lateral prostatic lobe significantly increased with PV (<30cc: 1 injection [0-1] vs 30-80cc: 2 injections [1-2] vs >80cc: 3 injections [2-3.5], p < 0.001). When compared to baseline, the combined cohort saw significant percent changes at 48-months in IPSS (-70.6%, p < .001), QoL (-80%, p < .001), and Qmax (52%, p = 0.003). Within each PV cohort, significant improvements in IPSS and QoL were found at all follow-ups when compared to baseline. Qmax improvements were significant only in the 30-80cc cohort at all follow-ups. There were no significant differences in percent changes in IPSS, QoL, or Qmax between cohorts at 3-, 6-, 12-, or 48-months when compared to baseline. The <30cc and 30-80cc cohorts had significant decreases in BPH medication usage as early as 3-months that remained durable through 48-months (all p < 0.05). The >80cc cohort experienced a significant decrease in BPH medication usage at 3-months but it did not remain durable to 12- or 48-months. No significant differences in postoperative AEs or decision regret scores were observed between cohorts. There were no significant changes in erectile function and orgasmic function at 12-months within cohorts. No significant differences were found in 48-months reoperation rates between the <30cc, 30-80cc, and >80cc cohorts (0% vs 4.9% vs 5%, p = 0.49). Conclusions Rezum effectively improved LUTS secondary to BPH irrespective of PV, with improvements being durable over 4 years. However, patients with PVs >80cc should be counseled on the possibility of continuing their BPH medications following treatment. Disclosure No.

(134) Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie’s Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We have previously published outcomes of men undergoing a novel protocol for CCH injections and which demonstrated significant improvements compared to original IMPRESS I and II techniques. We therefore sought to evaluate results of men who had previously failed CCH injections to determine if they would respond to a repeat course using a more aggressive protocol. Objective To evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants had previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 22/40 men have been randomized to date, with 11 having fully completed treatment. Mean age was 64 years, with a median PD duration of 24 months. Mean composite baseline curvature was 80 degrees, with 55% having hourglass or indentation deformities, 10% calcification, median baseline IIEF-EFD 15, and 60% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 19.4), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (60% vs 30% satisfied, 10% neutral). Of the 11 men who had completed the study protocol, 64% required 1 series, 9% 2 series, 18% 3 series, and 9% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (mean 78 degree vs 15, p=0.01). IIEF-EFD was also improved more in treated men (+4.3 vs -5.7, p<0.05). 100% of men reported a subjective major improvement in curvature, with the average subjectively estimated improvement 91%. 67% reported improved sensitivity (33% no change), while 60% reported improved or no change in erectile function, with 20% unsure, and 20% somewhat worse. Post-treatment, 83% of men were very satisfied with CCH as a treatment and 17% somewhat satisfied. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Matthew Ziegelmann - Endo Pharmaceuticals.

(313) Low-Intensity Extracorporeal Shockwave Therapy May Result in Improvements in Flaccid Cavernosal Artery Peak Systolic Velocity

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) is thought to treat erectile dysfunction (ED) by stimulating neovascularization and nerve regeneration. Studies suggest subjective improvements following treatment, but objective measures are sparse. Objective We aimed to objectively assess the efficacy of LiESWT in the treatment of ED using penile Doppler in men with ED following LiESWT therapy. We hypothesized that LiESWT results in demonstrable increases in penile blood flow. Methods Patients were prospectively enrolled in a clinical trial examining objective and subjective changes in erectile function following LiESWT. Patients underwent baseline examination with penile Duplex ultrasound in both the flaccid and rigid states following intracavernosal injection of alprostadil. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment, with follow up Duplex at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Highest peak systolic velocity (PSV) and lowest end diastolic velocity (EDV) were reported. Results Twenty-five patients completed all five study visits. The mean highest PSV in the flaccid state prior to treatment was 7.86 cm/s (± 1.47), which significantly increased to 11.31 cm/s (± 1.81, p < 0.05) immediately following completion of treatments. This increase was sustained at 4-6 weeks with a mean PSV of 12.74 cm/s (± 1.80, p < 0.05), followed by 10.74 cm/s (± 1.43, p < 0.05) at 3 months, and 9.87 cm/s (± 1.14, p=0.11) at 6 months (Figure 1). No significant improvements were noted in flaccid lowest EDV or rigid peak PSV/lowest EDV. Conclusions Our results suggest that LiESWT may improve baseline penile vascularity. Overall, the clinical significance of the noted improvement in flaccid PSV after LiESWT remains to be determined and more work needs to be done to define the mechanism of action of LiESWT at a tissue level in human subjects. Disclosure No.

(231) Low-Intensity Extracorporeal Shockwave Therapy Twice Per Week for Six Weeks May Result in Transient Subjective Improvements in Erectile Function

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) has been reported to result in subjective improvements in erectile function, but the ideal patient population and treatment protocol have not yet been established. Objective We aimed to assess improvements in International Index of Erectile Function – Erectile Function domain (IIEF-EF) scores following treatment with LiESWT of 1500 shocks of 0.2mJ/mm2 per treatment, twice a week for six weeks. We hypothesized that LiESWT results in subjective improvements of erectile function. Methods Patients were prospectively enrolled in a clinical trial examining changes in erectile function following LiESWT. The study was powered to detect a change in IIEF-EF scores of 5 points. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment using the Storz Duolith T-Top Ultra shockwave device. Patients completed IIEF-EF, Sexual Encounter Profile (SEP) questions two and three, Global Assessment Questions (GAQ), and Erection Hardness Score (EHS) questionnaires prior to initiation of treatments and following completion of treatments at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Changes in questionnaire responses were compared to baseline responses. Data were analyzed using single variant one-tailed T-tests and one-tailed Fisher’s exact test. Values are reported as means ± standard error. Results Twenty-five patients completed all five study visits. Mean pre-treatment IIEF-EF score was 14.24 ± 1.21. Mean IIEF-EF scores increased to 15.80 ± 1.46 1-2 weeks following treatment (Study Time #2), 16.12 ± 1.46 4-6 weeks following treatment (Study Time #3), 18.12 ± 1.57 3 months following treatment (Study Time #4), and 16.36 ± 1.86 6 months following treatment (Study Time #5), though results only reached significance at Study Time #4 (p=0.016) and results were not sustained. Changes in IIEF-EF scores following treatment were evaluated by baseline ED severity (normal IIEF-EF 26-30, N=1; mild IIEF-EF 22-25, N=2; mild-moderate IIEF-EF 17-21, N=7; moderate IIEF-EF 11-16, N=10; severe IIEF-EF 6-10, N=5. Patients with IIEF-EF scores 11-21 reported significant improvements in IIEF-EF scores at all time points (Figure 1). Mean pre-treatment EHS score was 2.1±0.14. There was no significant improvement in EHS score following treatment at any time point, and no differences when analyzed based on pre-treatment ED severity. Similarly, no changes in SEP or GAQ positive response rates were noted following treatment. Conclusions Our results suggest that LiESWT using 1500 shocks per treatment with energy of 0.2mJ/mm2 twice per week for 6 weeks may transiently improve subjective erectile function as measured using IIEF-EF questionnaires, particularly for patients with mild-moderate to moderately severe ED, consistent with other studies. However, improvements may not be sustained 6 months following treatment. Disclosure No.

Irreversible Electroporation for the Focal Treatment of Prostate Cancer: A Systematic Review.

Irreversible electroporation (IRE) is a promising alternative treatment for low-intermediate-risk localized prostate cancer. In this systematic review we aim to evaluate the safety profile and functional and oncological outcomes of this new technique. A systematic review of the literature was performed on PubMed, EMBASE, and Scopus up to 24 August 2023. Nineteen studies were analyzed, including 12 prospective studies and 7 retrospective studies. A total of 1,452 patients underwent IRE as the sole primary treatment modality. The in-field clinically significant prostate cancer rate was reported between 0%-15.6% in the repeat biopsy. The retreatment rate was reported from 8% to 36.6%. The 3 years failure-free survival was presented between 90%-96.8%. The post-operative pad-free rate ranged between 96.7%-100%. Greater heterogeneity exists considering the change in erectile function. The most common reported complications were urinary tract infection and hematuria. Major complications were rare. These results underline that IRE achieves favorable oncological control with an excellent safety profile, in the meantime preserving patients' urinary and erectile function.

Erectile Dysfunction after Transuretheral Resection of the Prostate in Patients with Benign Prostatic Hyperplasia

Background: Benign prostatic hyperplasia (BPH) is commonly associated with lower urinary tract symptoms (LUTS) in aging men, which can significantly impact their quality of life. Transurethral resection of the prostate (TURP) is a standard treatment for BPH, yet its effects on erectile function remain controversial. Objective: To assess the impact of TURP on erectile function in patients with BPH and to evaluate the potential relationship between the relief of obstructive urinary symptoms and changes in erectile function postoperatively. Methods: This single-center, non-randomized study enrolled 177 male patients aged 50 to 80 years with a clinical diagnosis of BPH and an International Prostate Symptom Score (IPSS) greater than 8. Participants underwent monopolar TURP and were evaluated using the International Index of Erectile Function (IIEF-5) questionnaire one month post-surgery. Data were analyzed using SPSS version 21 with Chi-square tests applied to examine the influence of age and IPSS scores on erectile function, considering a p-value ≤0.05 as significant. Results: The mean age of participants was 57.53 ± 6.96 years, and the mean resected prostate tissue weight was 122.82 ± 12.05 grams. Post-TURP, 44.6% of patients were found to have some degree of erectile dysfunction. However, no significant changes in erectile function were observed one month following TURP (p=0.602 for age, p=0.878 for IPSS score). Conclusion: TURP did not significantly affect erectile function one month postoperatively in BPH patients with severe urinary symptoms. While some improvement in erectile function was noted, the results suggest that the benefits of TURP on erectile function may not be immediate. Further longitudinal studies with larger sample sizes are required to provide more definitive conclusions.

Changes in Sexuality and Sexual Dysfunction over Time in the First Two Years after Treatment of Head and Neck Cancer.

The aim of this study was to investigate changes in sexuality and sexual dysfunction in head and neck cancer (HNC) patients in the first two years after treatment, in relation to the type of treatment. Data were used of 588 HNC patients participating in the prospective NETherlands Quality of life and Biomedical Cohort Study (NET-QUBIC) from diagnosis to 3, 6, 12 and 24 months after treatment. Primary outcome measures were the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). The total scores of the IIEF and FSFI were dichotomized into sexual (dys)function. In men, type of treatment was significantly associated with change in erectile function, orgasm, satisfaction with intercourse, and overall satisfaction. In women, type of treatment was significantly associated with change in desire, arousal, and orgasm. There were significant differences between treatment groups in change in dysfunctional sexuality. A deterioration in sexuality and sexual dysfunction from baseline to 3 months after treatment was observed especially in patients treated with chemoradiation. Changes in sexuality and sexual dysfunction in HNC patients were related to treatment, with an acute negative effect of chemoradiation. This effect on the various domains of sexuality seems to differ between men and women.

Functional outcomes and safety of focal therapy for prostate cancer: a systematic review on results and patient-reported outcome measures (PROMs).

Focal therapy (FT) is a promising alternative with curative intent for Low- to Intermediate-risk localized Prostate Cancer (PCa), claiming better functional outcomes and safety profile than standard whole-gland treatments. Ten different FT modalities have been described in the literature. The objective of our narrative review is to evaluate the safety profile and functional outcomes of these different modalities and the currentmost used tools of assessment for those outcomes. Literature search was performed on 21stFebruary 2023 using PubMed, EMBASE, and Scopus, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA). Articles reporting whole-gland treatments were excluded. All articles reporting functional outcomes were included. One-hundred-seven studies, reporting data on 6933 patients, were included (26 on High Intensity Focal Ultrasound, 22 on Focal Cryotherapy, 14 on Irreversible Electroporation, 11 on Focal brachytherapy, 10 on Focal Laser Ablation, 8 on Photodynamic Therapy, 3 on Microwave ablation, 3 on Robotic Partial Prostatectomy, 2 on bipolar Radio Frequency Ablation, 1 on Prostatic Artery Embolization, and 7 studies comparing different FTs). Post-operative pad-free rate ranged between 92.3-100%. Greater heterogeneity exists considering the Change in Erectile Function, with Changing in Erectile function- rates ranging between 0-94.4% (Cryotherapy). The most used Patient-Reported Outcome Measures (PROMs) were the International Prostate Symptom Score and the International Index of Erectile Function for incontinence/urinary function and potency, respectively. The most common reportedcomplications were hematuria, infections, and urethral strictures, with rates widely ranging among different treatments. The Clavien-Dindo Classification was the most used (40/88 papers) to describe adverse events. FT is a promising treatment for localized PCa, achieving excellent results in terms of safety and functional outcomes. There is a wide heterogeneity in the definition of PROMS and time of collection between studies. High quality comparative studies with standard treatments are needed to reinforce these findings.

Mucomucosal anastomotic non-transecting augmentation (MANTA) urethroplasty: a ventral modification for obliterative strictures.

To present a surgical modification for the repair of bulbar urethral strictures containing short, highly obliterative segments and report on long-term objective and patient-reported outcomes. We considered patients undergoing bulbar buccal mucosal graft urethroplasty (BMGU) between July 2016 and December 2019. Eligibility criteria for mucomucosal anastomotic non-transecting augmentation (MANTA) urethroplasty were strictures of ≥2 cm with an obliterative segment of ≤1.5 cm. The stricture is approached ventrally to avoid extensive dissection and mobilisation. Dorsally, the scar is superficially excised and the spongiosum is left intact. Dorsal mucomucosal anastomosis is complemented by ventral onlay graft. Perioperative characteristics were prospectively collected including uroflowmetry data and validated patient-reported outcome measures on voiding, erectile, and continence function. We evaluated functional follow-up, incorporating patient-reported (lower urinary tract symptoms [LUTS] score) and functional success. Recurrence was defined as need of re-treatment. Of 641 men treated with anterior BMGU, 54 (8.4%) underwent MANTA urethroplasty. Overall, 26 (48%) and 45 (83%) had a history of dilatation and urethrotomy, respectively, and 14 (26%) were redo cases. Location was bulbar in 38 (70%) and penobulbar in 16 patients (30%), and the mean (SD) graft length was 4.5 (1.4) cm. At a median (interquartile range) follow-up of 41 (27-53) months, the functional success rate was 93%. Whereas the median LUTS score significantly improved from baseline to postoperatively (13 vs 3.5; P < 0.001), there was no change in erectile function (median International Index of Erectile Function - erectile function domain score 27 vs 24) or urinary continence (median International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form sum score 0 vs 0; all P ≥ 0.4). All patients were 'satisfied' (27%) or 'very satisfied' (73%) with the outcome of their operation. With excellent long-term objective and patient-reported outcomes, MANTA urethroplasty adds to the armamentarium for long bulbar strictures with a short obliterative segment.

Sexual satisfaction in prostate cancer: a multi-group comparison study of treated patients, patients under active surveillance, patients with negative biopsy, and controls.

Erectile function changes after prostate cancer (PCa) treatment are well documented, but less understood is the relative impact of prostate biopsy and active surveillance on sexual well-being. It is unknown whether potential negative impacts are exclusive to patients who have been treated for PCa, or whether the diagnosis itself or the experience of biopsy may also impact sexual well-being. Sexual satisfaction is an important yet understudied indicator of sexual well-being in this population. This study examines sexual satisfaction and its predictors across several comparison groups to explore relative impact. At baseline and 12months, questionnaire data was collected in four samples: (1) following PCa treatment, (2) active surveillance, (3) negative prostate biopsy result, and (4) controls receiving no biopsy or treatment. Predictors assessed included group, erectile function, communication style, and partner involvement. Sexual satisfaction declined in the active treatment group, no changes were observed in active surveillance or non-PCa control, and improvements were observed in the biopsy group. Predictors of sexual satisfaction over and above erectile function included restrictive communication (i.e. protective buffering) and perceived partner involvement. For higher levels of erectile function, a higher perceived degree of partner involvement was protective of sexual satisfaction. Sexual satisfaction is an important indicator of sexual well-being and is negatively impacted following PCa treatment, but not active surveillance or prostate biopsy. Communication and partner involvement are potentially modifiable factors to be considered for intervention and may promote sexual satisfaction following PCa treatment. Patients experiencing negative biopsy, who note lower sexual satisfaction may experience improved satisfaction with time, and those under active surveillance who worry about sexual satisfaction may find reassurance from these results.

The Change of Erectile Function Post Recovery from COVID-19 Infection

Introduction: We assess the correlation between COVID-19 infection and erection and evaluate the effect of aging and comorbidities on the male sexuality of patients with COVID-19 infection. Methods: 100 patients were enrolled and diagnosed with COVID-19 based on reverse transcription-polymerase chain reaction tests of oropharyngeal and nasopharyngeal swabs according to the WHO guidelines. The International Index of Erectile Function (IIEF-5) questionnaire was used to evaluate sexual function. Results: Patients were divided into two groups: the first group of 42 patients <50 years of age with a mean age (±SD) of 35.83 ± 7.8 and the second group of 58 patients ≥50 years of age with a mean age of 58.64 ± 7.7. The mean (±SD) IIEF in the first group pre-COVID-19 infection was 14.2 ± 2.37 while post-COVID-19 was 8.7 ± 2.77, 11.3 ± 2.9, 12.1 ± 3.02 at 1, 3, 6 months, respectively (p < 0.001), while in the second group, the mean (±SD) IIEF pre-COVID-19 infection was 10.04 ± 4.62 while post-COVID was 5.0 ± 2.1, 6.56 ± 2.6, 8.18 ± 2.04 at 1, 3, 6 months, respectively (p < 0.001). On multivariate analysis, old patients infected with COVID-19 and associated with comorbidities such as diabetes mellitus (OR = 8.53, CI = 0.00–2.01), hypertension (OR = 3.908, CI = 0.000–3.07), ischemic heart disease (OR = 2.863, CI = 0.000–2.68), and liver disease (OR = 0.670, CI = 0.000–1.670) were significantly correlated to erectile dysfunction (p < 0.001). Conclusion: COVID-19 significantly affects erection mostly in older patients with comorbidities, leading to subsequent use of oral and intracavernosal injection therapy for erectile dysfunction.

(020) Implementing a Virtual Mindfulness-based Group Therapy to Improve Male Sexual Dysfunction

Abstract Introduction Erectile dysfunction (ED) is almost always multi-factorial. Simultaneous performance anxiety and psychogenic inhibition can impair erectile function even when underlying organic aetiologies are present. Sex therapy should be considered first-line treatment for ED. Mindfulness is a technique to focus on being aware of what you're sensing and feeling in the moment, without interpretation or judgment. Mindfulness-based therapy programs have been successful at improving female sexual dysfunction and prostate cancer survivors quality of life (QOL). Objective To design and evaluate the feasibility of a virtual, mindfulness-based group therapy (vMBGT) program for patients experiencing mild-to-moderate ED. We secondarily assess relationship satisfaction, QOL, and changes in erectile function after intervention. Methods A mixed-methods approach was taken for this feasibility pilot study. A total of 18 participants (mean age: 42; range 22-69 years) with ED were recruited to participate in a 4-week virtual mindfulness-based group therapy program. Three groups were led by trained facilitators on a weekly basis via Webex platform and ran 1.5-2 hours in length, followed by daily home-practice and sex education between sessions. Participants completed questionnaires (International Index of Erectile Functioning, Erection hardness scale, Relationship Assessment Scale, Five Facets of Mindfulness Questionnaire) as a baseline and 3 months after treatment. Qualitative exit interviews and program feedback was requested from all participants. Results The dropout rate for this study was 11%. Two of the eighteen men missed 2 of the 4 sessions; one participant dropped out and one had unanticipated work commitments. There was a statistically significant improvement in the mean IIEF scores from baseline 41 to 49 after vMBGT intervention (p &amp;lt; 0.05). There was a clinically significant improvement in SHIM score by 4 points. There was an improvement in EHS at 3 months compared to baseline (p=0.08) Overall, feedback was positive, and all participants responded that they would recommend this program to others. Some participants felt that the material could be lengthened to 6 weeks and/or that an in-person setting would have been more interactive, whereas others appreciate the convenience and comfort of the virtual platform. Conclusions This is the first published vMGBT program for patients experiencing mild to moderate ED. This program is feasible, the content was well received, and patients had improvement in their erectile function and QOL. Our pilot study has provoked a change to the treatments we can offer patients with ED and we have modified the program based on feedback. Further studies are needed to compare this to medical management and other psychotherapy interventions. Disclosure No

Analysis of Repair Type and Hypogastric Artery Antegrade Perfusion and Erectile Function following Repair of Abdominal Aortic Aneurysms

Published reports suggest that exclusion of antegrade hypogastric artery flow may have deleterious effects on erectile function after abdominal aortic aneurysm (AAA) repair. Off-label and open surgical hybrid procedures and, more recently, purpose-built branched devices have been developed to maintain antegrade pelvic perfusion in patients undergoing endovascular repair. Maintaining antegrade perfusion may reduce a spectrum of risks, including buttock claudication, colorectal ischemia, and spinal cord ischemia when patients undergo subsequent thoracic aortic procedures, as well as erectile dysfunction (ED). This project specifically focuses on erectile function, and analyzes baseline associations and relationships of hypogastric artery exclusion on changes in erectile function following aneurysm repair. Male patients in the Veterans Affairs Open Versus Endovascular Repair (CSP#498; OVER) Trial had erectile function assessed preoperatively and postoperatively by administration of the International Index of Erectile Function-5 questionnaire. Bayesian mixed-effects regression models were created with the outcome variable (erectile function) treated as a latent variable. Primary effects of differences in erectile function between groups with and without preservation of bilateral antegrade hypogastric flow were compared. 876 men (442 randomized to endovascular repair) were enrolled in the trial and included in the analysis comparing treatment assignment. There is significant ED in elderly men with aortic aneurysm at baseline. Over 5years of follow-up, there is modest decrease in erectile function and the endovascular group has improved function compared to open repair (0.082; 95% credible interval (CI) 0.008 and 0.155). A fifth of patients did not have bilateral preservation of antegrade hypogastric artery perfusion, with no difference in erectile function by univariate analysis. A more detailed regression analysis was applied--and after adjustment for baseline score, age, beta blocker use, diabetes, activity level, ejection fraction, preoperative ankle-brachial indices and time--preservation of both antegrade hypogastric arteries' perfusion showed transient improvement in survey scores compared to occlusion of at least 1 hypogastric artery at 6months and 12months after treatment, although this was not sustained at 60months (score change: 0.046; 95% CI: -0.123, 0.215). Retesting this model in the cohort with complete data as a sensitivity analysis did not meaningfully change the conclusions. In this large prospective aneurysm treatment trial with systematic measurement of erectile function with a validated instrument, endovascular repair is associated with improved erectile function. Preservation of antegrade hypogastric flow with any repair is associated with early improved erectile function; however, it is not a sustained benefit. There is limited benefit of maintaining bilateral hypogastric artery perfusion for this specific indication in unselected men undergoing AAA repair.

PD11-09 PROSPECTIVE RANDOMIZED TREATMENT OF ERECTILE DYSFUNCTION AFTER RADICAL PROSTATECTOMY WITH AUTOLOGOUS ADIPOSE-DERIVED REGENERATIVE CELLS

You have accessJournal of UrologyCME1 Apr 2023PD11-09 PROSPECTIVE RANDOMIZED TREATMENT OF ERECTILE DYSFUNCTION AFTER RADICAL PROSTATECTOMY WITH AUTOLOGOUS ADIPOSE-DERIVED REGENERATIVE CELLS Sabrina Toft Hansen, Sabrina Hansen, Charlotte Harken Jensen, Ditte Caroline Andersen, Per Damkier, Jens Ahm Sørensen, and Lars Lund Sabrina Toft HansenSabrina Toft Hansen More articles by this author , Sabrina HansenSabrina Hansen More articles by this author , Charlotte Harken JensenCharlotte Harken Jensen More articles by this author , Ditte Caroline AndersenDitte Caroline Andersen More articles by this author , Per DamkierPer Damkier More articles by this author , Jens Ahm SørensenJens Ahm Sørensen More articles by this author , and Lars LundLars Lund More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003251.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We have previously reported safety and preliminary efficacy outcomes from a phase 1 clinical trial using autologous adipose-derived regenerative cells (ADRCs) to treat erectile dysfunction (ED) in 21 men after radical prostatectomy (RP). To further evaluate the effectiveness of the stem cell intervention, we here performed a randomized double-blind placebo-controlled phase 2 trial. METHODS: The trial was approved by The Danish National Committee on Health Research Ethics (60915) and included 70 men (58-67 years) with normal erectile function (EF) before robotic-assisted RP, and undetectable PSA levels at inclusion. Patients were randomized (35:35) to placebo or ADRC treatment using REDCap. The trial's primary endpoint was changes in EF using the International Index of Erectile Function 5 (IIEF-5) and Erection Hardness Score (EHS) questionnaires as an online survey at baseline, 1, 3, 6, and 12 months after treatment. The secondary endpoint was an objective measure of nocturnal erection at baseline and 6 months after treatment using RigiScan® that besides the frequency-, registers tumescence- (TAU) and rigidity (RAU) of erections at the base and tip of the penis during sleep. As a normal reference, RigiScan® -values from men of similar age and no ED were used. All 70 participants underwent liposuction of 200-360 ml from the abdominal subcutis and ADRCs were isolated using a Cytori Celution® System. Immediately after isolation, the patient received an injection into each corpus cavernosum of 2 ml with either Ringer`s lactate or ADRCs. RESULTS: The two groups were similar regarding age and comorbidity. Patient-reported outcome measures showed no statistical difference between groups in either the IIEF-5 or EHS scores at baseline, 1, 3, 6, or 12 months. RigiScan® evaluation following method validation and reference setting, showed that for each of the four RAU/TAU parameters, more patients in the treatment group had a response beneficial effect compared to the placebo group with tip TAU being significantly higher (46% vs 11%; p=0.0097). We observed that the probability for improvement in EF remained higher in the treatment group independent of the time between surgery and treatment. No severe adverse events related to the treatment were reported during the follow-up period. CONCLUSIONS: In conclusion, ADRCs had no measurable effect on IIEF-5 and EHS scores in this study. ADRCs injected into the corpora cavernosum had some effect as evaluated by Rigiscan®, which suggest a potential for ADRC in subgroups of patients despite negative clinical findings in this study. Source of Funding: Innovation Found Denmark © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e335 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sabrina Toft Hansen More articles by this author Sabrina Hansen More articles by this author Charlotte Harken Jensen More articles by this author Ditte Caroline Andersen More articles by this author Per Damkier More articles by this author Jens Ahm Sørensen More articles by this author Lars Lund More articles by this author Expand All Advertisement PDF downloadLoading ...