Köhler, Tobias

Abstract Background Erectile dysfunction (ED) is a known precursor and sequela of cardiovascular disease (CVD), with ED severity predicting CVD severity. Aim This study aimed to evaluate the utility of ceramide levels in patients with ED. Methods We initiated ceramide testing in all patients with ED. We retrospectively analyzed ceramide levels from electronic records and stratified by severity of symptoms using the erectile function domain of the International Index of Erectile Function (IIEF). Outcomes The study aimed to determine whether abnormal ceramide levels were associated with ED severity and increased cardiovascular risk. Results Three hundred and fifty-four patients were reviewed, of whom 253 (71.5%) had moderate or higher ED. A statistically significant difference in abnormal ceramide values was found in patients with moderate to severe symptoms, and the odds of getting an abnormal ceramide test were increased based on the IIEF scoring alone (odds ratio [OR] 2.3 [1.04-5.12]; P-value = .034). Clinical Implications Serum ceramide testing could be beneficial in identifying cardiovascular risk in men with ED, potentially prompting cardiac referrals and lifestyle modifications. Strengths and Limitations The strengths of this study include a large sample size and the use of a well-established scale, while the limitations include the retrospective nature of the study and the need for further research to validate the findings. Conclusion Patients undergoing management for ED may benefit from serum ceramide testing and subsequent cardiac referral.

Abstract Introduction Vacuum erectile device (VED) is 1 of the main approved therapies for erectile dysfunction (ED). The introduction of phosphodiesterase type 5 inhibitor (PDE5i) for ED significantly changed the roles of VED in contemporary sexual medicine. Objective To provide updated clinical evidence to inform health care providers on best practices with VED. Methods A consensus panel was held with leading sexual medicine experts during the 5th International Consultation on Sexual Medicine (ICSM). Relevant peer-reviewed literature was reviewed with focus on research from the last 10 years, but not limited to the last 10 years. The expert panel generated consensus statements based on the quality of evidence and criteria of Grading of Recommendations Assessment, Development and Evaluation. Results As a primary or combination therapy for ED, VED has been shown to be successful in all populations studied, including difficult to treat cohorts, such as diabetes mellitus, spinal cord injury, and post-radical prostatectomy (RP), but long-term attrition rates are high. Available evidence has shown that VED can preserve or restore penile size for patients after RP, after incision and grafting surgery for Peyronie’s disease, before and after penile prosthesis, and after other post pelvic surgeries. However, it has not demonstrated a more rapid recovery of spontaneous erectile function after RP. VED does not increase penile length for subjective short penis. Studies with female specific VED for female sexual dysfunction are very limited. Conclusions Since the prior 4th ICSM, more evidence is available to support the new roles of VED in contemporary sexual medicine. Research into the penile pathophysiologic changes with VED therapy and clinical outcomes for various conditions are ongoing. We encourage sexual medicine clinicians to follow the 5th ICSM recommendations, but providers should also use their own judgement and adopt shared decision making with their patients/partners when considering VED for a specific disorder.

Abstract Background Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as a dip and irrigation solution at time of inflatable penile prosthesis (IPP) surgery. Aim This study evaluated infection rates before and after implementing CHG protocol while investigating concurrent risk factors contributing to post operative infections. Methods A retrospective, consecutive cohort study was performed that included patients who underwent insertion of a Coloplast Titan IPP including both virgin and revision cases between 2021 and 2024. Cases performed from January 2021 to August 2022 utilized rifampin/gentamicin for dip and vancomycin/gentamicin for irrigation (ABX), whereas those from October 2022 to May 2024 utilized CHG for both dip and irrigation. Perioperative risk factors including dip and irrigation solution used at time of surgery were compared between groups. Outcomes We defined the incidence of postoperative infection and risk factors associated with infection in each group. Results The incidence of infection was significantly higher in the 0.05% CHG group (13/377) compared to the ABX group (0/320) (P < .001). When analyzed separately by subgroup, virgin cases treated with CHG for dip and irrigation demonstrated a significantly higher infection rate (7/315) compared to those in the ABX group (0/280) (P = .012). Similarly, in revision cases, the CHG group also exhibited a significantly higher infection rate (0/40) than the ABX group (6/62) (P = .043). Univariable analysis of the CHG cohort identified three significant risk factors for infection: diabetes mellitus (DM), extended operative time (OP), and revision surgery (P = .003, .001, and < .001, respectively). Multivariable regression analysis revealed that patients with DM had a 5.7-fold increased risk of infection (OR: 5.70, P = .004), while those undergoing revision surgery faced a 5.3-fold higher risk (OR: 5.26, P = .004). Additionally, each minute increase in OP was associated with a 1% higher infection risk (OR: 1.01 per minute, P = .007). These associations remained significant after adjusting for all variables in the model. Clinical Implications Prosthetic surgeons should be cautious about adopting 0.05% CHG for both dip and irrigation in the absence of strong clinical evidence demonstrating its non-inferiority to antibiotic solutions. Strengths and Limitations This is the first clinical study reporting infection rates after IPP surgery using 0.05% CHG for both dip and irrigation. While retrospective and non-randomized, we present a relatively large sample size of patients. Conclusions Our findings identify four risk factors for penile prosthesis infection: usage of the 0.05% CHG solution for dip and irrigation solution of Coloplast hydrophilic-coated devices, DM, revision surgery, and extended OP.

Abstract Introduction Convective water vapor thermal therapy (Rezum) can have varied outcomes based on prostate architecture. Objective We sought to compare the efficacy of traditional Rezum therapy with steam treatment of the median lobe to transurethral resection for the median lobe, and Rezum treatment for the lateral lobes of the prostate (Rezurp). Methods A single-surgeon series between 2019 and 2024 analyzed standard BPH outcomes. The rate of retreatment, complications, and a global assessment: “Knowing what you know now, would you like to repeat the procedure?” were utilized. Significant median lobe was defined as ≥1 cm of intravesical protrusion for Rezurp patients and ≥ 2 median lobe treatments required for standard Rezum. Results Follow-up assessments were performed for 89/105 patients in the Rezurp group and 107/138 patients in the Rezum group. There was no significant difference in baseline characteristics between the two groups, as shown in Table 1. In the Rezum group, the median IPSS before surgery was 25 (20–28), while the median score after surgery was 9 (5–15), and in the Rezurp group, the median IPSS before surgery was 22.5 (19–28), and the median score after surgery was 5 (3–9.7). The changes were statistically significant for both groups (P < 0.001). For the IPSS quality-of-life (QoL) scores, the median in both groups was 4 (mostly not satisfied) before surgery and 2 (mostly satisfied) after surgery. The changes in QoL scores were significant in both (P < 0.001). In the Rezum group, the median Q-max was 7.9 and 13.1 before and after surgery, while in the Rezurp group, it was 8.0 and 17.1, respectively, and the changes were significant for both (P = 0.001). In addition, changes in post-voiding residue were significant in both groups (P = 0.001) (Table 2). In the Rezum group, 62% (67 patients) were on alpha-blockers before surgery, whereas only 15.8% (17 patients) continued after surgery. For the Rezurp group, 71.9% (64 patients) were on alpha-blockers before surgery, compared to 10.1% (9 patients) afterward. The discontinuation of alpha-blockers was significant for both groups (P = 0.001). Furthermore, changes in stopping the use of 5-alpha reductase inhibitors were significant for both groups (P = 0.001). The changes in stopping PDI-5 were not significant in both groups (P = 0.38). Regarding retreatment, 5.6% (5 out of 89) of patients in the Rezurp group required a retreatment procedure, compared to 14.9% (16 out of 107) in the Rezum group. The retreatment rate was significantly higher in the Rezum group (P = 0.03). When asked if they would repeat the procedure, 91% (81 out of 89) in the Rezurp group expressed interest, compared to 72% (77 out of 107) in the Rezum group. The interest in repeating the procedure was significantly higher in the Rezurp group (P = 0.001). Conclusions Although both Rezum therapy and Rezurp resulted in significant improvements in Q-max, PVR, IPSS, and QoL, the Rezurp group had a significantly lower rate of retreatment. Disclosure No.

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.

Abstract Introduction Treatment of patients with obstructive lower urinary tract symptoms has various side effects on their quality of sexual life. Objective This study aimed to compare the effects of Rezum and Rezurp (a combination of Rezum for lateral lobes and TURP for the median lobe) on erections, retrograde ejaculation, and subjective orgasm experience in patients with a significant median lobe. Methods This is a retrospective cohort study that includes patients who underwent Rezum and Rezurp between January 2021 and January 2024. Sexual outcomes were assessed at 3 months and a median follow up phone call was 33 months. Patients were queried: Any changes in erections (yes/no) and changes in ejaculation (yes/no). If yes to changes, patients were asked to further define and characterize their responses including specific effect on orgasm. The effect of surgery on sexual outcomes was explored by chi-square analysis with P ≤ 0.05 considered statistically significant. Results Sexual outcomes were obtained for 78/89 patients in the Rezurp and 97/107 patients in the Rezum group. There was no significant difference in baseline characteristics, including age, prostate volume, and medication regimens, between the two groups, as shown in Table 1. The results indicated that 78% (61/78) and 83% (86/97) of Rezurp and Rezum patients experienced no change in ejaculation. Total ejaculation loss was seen only in two Rezurp patients. Ejaculatory changes between the two groups were not significantly different, with 13.8% and 4.23% worsening for Rezurp and Rezum, respectively (P = 0.08). Changes in erections and orgasm satisfaction were not statistically significant between the two groups (P = 0.76 and 0.54, respectively). Subjective worsening in orgasm quality for Rezurp and Rezum was not different between groups (P = 0.54), with 6.4% and 4.1% worsening, respectively (Table 2). Conclusions Rezurp and Rezum have similar sexual function outcomes. Disclosure No.

Abstract Introduction Concerns exist when inflatable penile prosthesis (IPP) surgery is performed following transcorporal artificial urinary sphincter (TC-AUS) due to risk of damaging the AUS cuff during proximal corporal dilation and device placement. Aside from rare case reports, no data exists on outcomes and complications in patients who undergo IPP surgery with existing TC-AUS in place. Objective We aim to describe perioperative complications, infections, revision rates, and device longevity when IPP surgery is performed with existing TC-AUS in place. Methods A retrospective search was conducted to identify all patients who had undergone TC-AUS placement at a single institution from 2015-2023. Patients who had undergone IPP placement following TC-AUS at the same institution were identified. Operative technique for IPP placement was similar to standard IPP surgery with additional care taken to avoid the AUS device and preferential use of electrocautery over sharp dissection. Operatives notes and all patient encounters were reviewed, and data on demographics, operative details, perioperative complications, infections, revision rates, and device longevity were recorded. Results 727 patients underwent TC-AUS placement from 2015-2023. Of these, 13 patients underwent subsequent IPP placement (fig. 1). All patients had history of prostatectomy, and 6 (46%) patients had prior radiation. The median follow-up after IPP was 31.7 months and the time gap between AUS and IPP averaged 18.3 months (range 2.3 to 56.7 months). Average operative time for IPP was 85 minutes (range 53 to 202 minutes). Reservoirs were all placed contralateral to the AUS reservoir to minimize risk of injury to the AUS device. 8 patients had a 12 Fr catheter left post-operatively for less than 24 hours. Proximal dilation was noted to be difficult in 2 patients (15%), both of which were successfully dilated without perforation or damage to the AUS cuff. No infections or erosions occurred. 3 patients (23%) developed mechanical failure at a mean time of 28.7 months following IPP placement (36.5 months after AUS). Cuff leak was identified in 2 patients and the third has yet to undergo revision surgery to determine etiology. Conclusions IPP placement appears safe and effective in men who have previously undergone TC-AUS without increased risk of infection or device erosion. Care should be taken when dilating proximally, though proximal dilation was uneventful in most patients. Mechanical failure rates may be slightly higher compared to patients who have either device alone, and patients should be counseled accordingly. Disclosure No.