Faculty Bibliography

PURPOSE/OBJECTIVE:To document the effect of the temporarily implanted nitinol device (iTind, Olympus, Shinjuku City, Tokyo, Japan) on sexual function from a multicenter, randomized, single-blinded, sham-controlled trial. METHODS:Men were randomized 2:1 between iTind and sham procedure arms. The iTind was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 3, and 12 months postoperatively using the Sexual Health Inventory for Men (SHIM) and International Index of Erectile Function (IIEF). Unblinding occurred at 3 months. RESULTS:We studied 185 men with a mean age of 61.1 ± 6.5 years. There was no difference in SHIM or total IIEF between iTind and sham at 3 months or in the iTind arm at 12 months compared to baseline. Men in the iTind arm without erectile dysfunction (ED) at baseline also showed an improvement in total IIEF score of +6.07 ± 21.17 points (p=0.034) at 12 months, in addition to an improvement in ejaculatory function. SHIM scores remained unchanged in all groups, regardless of age, prostate volume, or baseline erectile function. CONCLUSION/CONCLUSIONS:No changes were observed in sexual and ejaculatory function of patients with iTind regardless of a man's age, prostate volume, and baseline sexual function.

IL-15 Superagonist NAI in BCG-Unresponsive NMIBCIn this trial, patients with BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease or BCG-unresponsive high-grade Ta/T1 papillary NMIBC were treated with intravesical NAI, an IL-15 superagonist, plus BCG. Primary end points were CR at 3 or 6 months for patients with CIS disease and DFS rate at 12 months for those with high-grade Ta/T1 disease. CR rate was 71% (58 of 82 patients), and the DFS rate was 55.4%.

BACKGROUND:Long-term data evaluating the efficacy and safety of oral testosterone undecanoate (oral TU; JATENZO) in adult hypogonadal men provides important information for healthcare professionals who prescribe testosterone replacement therapy (TRT). AIM/OBJECTIVE:To determine the efficacy and safety of long-term oral TU therapy, including its impact on total testosterone (T) levels and psychosexual functioning. METHODS:Hypogonadal men, between 18 and 75 years old, (mean age 56.2; 87.2% white) who completed a 12-month, open-label, multicenter, randomized, active-controlled trial were given the opportunity to enroll in a 12-month extension study. Among the 129 eligible TU-treated subjects, 86 chose this option, and 69 completed 24 months of uninterrupted oral TU therapy. OUTCOMES/RESULTS:The efficacy of oral TU was documented by measuring total serum T concentrations; sexual function was measured using the Psychosexual Daily Questionnaire (PDQ). For safety, liver function tests, cardiovascular endpoints, and prostate health were measured. RESULTS:Over 2 years, total serum T concentrations for patients treated with oral TU were in the eugonadal range (300-1,000 ng/dL [10-35 nmol/L]; mean ± SD: 617 ± 427 ng/dL [21 ± 15 nmol/L]) and increased significantly from baseline (P < .0001). For sexual function, mean score changes versus baseline for all PDQ domains at all time points were significantly improved (P < .0011 for all). For the sexual activity and sexual desire components, patient scores were consistently greater than validated thresholds for clinically meaningful change. Typical T-induced safety changes were observed, including a 3-6 mm Hg increase in systolic blood pressure (P < .05); a slight increase in hematocrit (P < .0001) that stayed <48% throughout the study; no clinically significant changes in prostate-specific antigen levels; and decreased high-density lipoprotein cholesterol (-9.8 ± 0.9 mg/dL from baseline; P < .0001). There were no clinically significant changes from baseline in liver function tests. CLINICAL IMPLICATIONS/CONCLUSIONS:Over 2 years of treatment, this novel oral TU formulation maintained total T concentrations in mideugonadal ranges, with improvements in sexual function and no clinically significant changes in liver function or other safety concerns previously associated with oral TRT. STRENGTHS & LIMITATIONS/UNASSIGNED:These are the first long-term data to evaluate the efficacy and safety of a novel formulation of oral TU; the comparative long-term safety of oral TU would be strengthened by confirmatory studies versus other TRT formulations. CONCLUSION/CONCLUSIONS:Oral TU offers a safe and effective long-term treatment option for men with hypogonadism.

Intralesional injection of collagenase clostridium histolyticum (CCH) improves Peyronie's disease (PD) symptoms; however, patient perspectives regarding PD and CCH treatment have not been fully elucidated. This cross-sectional qualitative study included heterosexual men with PD who received ≥1 injection of study medication and had ≥1 posttreatment Peyronie's Disease Questionnaire (PDQ) assessment during a prior phase 2b clinical trial. These patients were "responders" if they reported (as part of the Global Assessment of the PDQ) that overall symptoms and effects of PD had at least "improved in a small but important way" after CCH therapy. Among 45 patients interviewed, penile bending or curvature was the most common and bothersome PD symptom reported (by 97.8% and 48.9% of patients, respectively). Patients indicated that multiple alterations were necessary in their sex lives because of penile symptoms and specified that these changes impacted their emotional health and partner relationship. Treatment with CCH improved PD symptoms (44.4%), frequency of or ability to have vaginal intercourse (22.2%) and partner relationship (22.2%), particularly among responders. Given that physical, psychologic and sexual function are impacted by PD, clinical trials that evaluate treatments for PD should include patient-reported outcome measures (e.g., the PDQ) to assess overall well-being after treatment.

PURPOSE/OBJECTIVE:SER120 is the first FDA-approved pharmacotherapy for nocturia. SER120 efficacy/safety was evaluated in 2 randomized, double-blind, placebo-controlled studies (DB3 and DB4). MATERIALS AND METHODS/METHODS:Patients aged ≥50 years with ≥ 2.16 nocturic voids/night during a 2-week screening period (N=1,333, intent-to-treat) were randomized equally to SER120 (intranasal spray) 1.66 mcg, 0.83 mcg, or placebo for a 12-week treatment. Co-primary endpoints: mean change from baseline in nocturic episodes/night and percentage of patients with ≥50% reduction in mean nocturic episodes/night. Secondary endpoints: validated QoL questionnaire, Impact of Nighttime Urination [INTU]) (DB4), time to first nocturic void, and percentage of nights with ≤1 nocturic voids. RESULTS:Both doses of SER120 (showed statistical significance vs placebo for both co-primary endpoints (mean nocturic episodes/night, -1.4 with 0.83 mcg and -1.5 with 1.66 mcg vs -1.2 with placebo [p < 0.0001 for both]; percentage of patients ≥50% reduction in mean nocturic episodes/night, 37.9% with 0.83 mcg and 48.7% with 1.66 mcg vs 30.3% with placebo [p = 0.0227 and p < 0.0001, respectively]) and all secondary endpoints in the pooled analyses. SER120 1.66 mcg demonstrated significant improvements in INTU score (p = 0.0255). Hyponatremia (serum sodium ≤125 mmol/L regardless of symptoms or <130 mmol/L with symptoms) was 1.1%, 0% and 0.2% in the 1.66 mcg, 0.83 mcg and placebo groups, respectively. Other adverse events were similar across treatment groups. CONCLUSIONS:SER120 demonstrated significant improvements over placebo for co-primary and secondary efficacy endpoints that corresponded with QoL improvements. SER120 at both doses had an acceptable safety profile. TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov Identifiers: NCT01357356; NCT01900704.

Purpose: To assess the International Prostate Symptom Score (IPSS) following the implant of a polymer encapsulated Pd-103 source with a unique linear radioactive distribution intended to provide a useful refinement on prostate brachytherapy. A registry study collects patient reported outcomes following brachytherapy, including the IPSS questionnaire. Materials/Methods: 37 subjects with prostate cancer were implanted with the Pd-103 line source. Prostate specific antigen (PSA) was recorded before implant and in 6 month intervals following implant. Patients were asked to respond to the IPSS questionnaire before implant, one month after implant, and at 6 month intervals following implant. PSA and responses to questionnaires have been collected for up to 24 months for some patients. Patients were not excluded based on pre-implant IPSS. Results: The average PSA prior to implant and at 6 months following implant were 7.7 and 1.2, respectively. A total of 37 patients responded to the questionnaires prior to linear Pd-103 implant. Mild increase in frequency and urgency reported following implant, resolving prior to 6 month follow up. The average baseline IPSS for all patients is 9.1. The pre-implant IPSS is known to impact the post implant results. of 37 patients, 9 patients had baseline IPSS $15 with an average of 19.2. 28 patients had a baseline IPSSS <15 with an average of 5.7. The average post implant IPSS change from baseline was 11.3, 3, 1.9, 3.1 and 0.3 for months 1, 6, 12, 18 and 24, respectively. The IPSS reported for Pd-103 linear sources indicate that return to baseline may occur more rapidly than with traditional seeds. Treatment strategy of monotherapy or combined BT+EBRT did not affect the IPSS resolution time. Conclusions: Preliminary results suggest that the temporary uropathy associated with Pd-103 line source brachytherapy may resolve more rapidly when compared to seeds in the published literature