Patient perspectives on Peyronie's disease: results of poststudy interviews from a phase 2 trial of collagenase clostridium histolyticum
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 includedÂ heterosexual men with PD who received â‰¥1 injection of study medication and had â‰¥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.
Re: Plication for severe peyronie's deformities has similar long-term outcomes to milder cases [Note]
Efficacy and Safety of SER120 Nasal Spray in Nocturia Patients Pooled Analysis of 2 Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials
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 â‰¥50 years with â‰¥ 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 â‰¥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 â‰¤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 â‰¥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 â‰¤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.
International prostate symptom score assessment following palladium-103 line source for prostate brachytherapy implants [Meeting Abstract]
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
Quality of erections by age group in men with erectile dysfunction
AIMS/OBJECTIVE:The aim of this study was to assess erection quality with sildenafil vs placebo and adverse events (AEs) according to age (â‰¤45, 46-55 and â‰¥56Â years) in 997 men with erectile dysfunction (ED) using pooled data from four randomized, double-blind, placebo-controlled, flexible-dose trials. METHODS:The trials included 6- to 10-week treatment periods. The starting sildenafil dose was 50Â mg, taken ~1Â hour before sexual activity but not more than once daily, with subsequent adjustment to 100 or 25Â mg based on efficacy and safety. Exclusion criteria included blood pressure <90/50 or >170/110Â mmHg, taking nitrate therapy or nitric oxide donors, severe cardiac failure/unstable angina or recent stroke or myocardial infarction. Changes from baseline in Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were analysed. RESULTS:Improvements in QEQ scores with sildenafil vs placebo were significant (P<.0001) for the overall sample (33.7 sildenafil; 8.1 placebo) and each age group (â‰¤45Â years: 38.5 sildenafil, 13.9 placebo; 46-55Â years: 34.9 sildenafil, 5.8 placebo; â‰¥56Â years: 26.9 sildenafil, 4.9 placebo). IIEF Erectile Function domain (P<.0001), question 3 (achieving erection; P<.003), and question 4 (maintaining erection; P<.001) scores also improved significantly for the overall sample and each age group. Treatment satisfaction was significantly greater (P<.0001) with sildenafil vs placebo for the overall sample and each age group. The most common AEs with sildenafil were headache, flushing and nasal congestion in all age groups. CONCLUSIONS:Sildenafil significantly improved erection quality across all age groups of men with ED. Efficacy improvements with sildenafil were consistent with the QEQ, IIEF, and EDITS. AEs were comparable across age groups. ClinicalTrials.gov ID: NCT00159900, NCT00147628, NCT00301262, NCT00343200.
SER120 NASAL SPRAY IS EFFECTIVE FOR THE TREATMENT OF NOCTURIA IN PATIENTS REGARDLESS OF ETIOLOGY: A POOLED ANALYSIS OF TWO RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 TRIALS [Meeting Abstract]
Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial
AIM: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women. METHODS: Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sexual function index and female sexual distress scale-desire/arousal/orgasm. RESULTS: Efficacy data, n = 327. For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180), +3.6 versus +1.9 female sexual function index total score (p = 0.0017), -11.1 versus -6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014). Adverse events: nausea, flushing, headache. CONCLUSION: In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).
SUBCUTANEOUS (SC) TESTOSTERONE ENANTHATE (TE) 50 MG AND 100 MG ADMINISTERED WITH A NOVEL, AUTO-INJECTOR (AI) PROVIDES EFFECTIVE TESTOSTERONE (T) REPLACEMENT [Meeting Abstract]
A green and black tea extract benefits urological health in men with lower urinary tract symptoms
OBJECTIVES/OBJECTIVE:The objective of this study was to examine the effects of a green and black tea extract blend [AssuriTEA Men's Health (AMH)] in men with lower urinary tract symptoms (LUTS). METHODS:In this randomized, double-blind, placebo-controlled study, 46 men aged 30-70 with an American Urologic Association symptom score (AUAss) of at least 8 and up to 24 were randomized to 500 mg AMH, 1000 mg AMH, or placebo daily for 12 weeks. Measurements were taken at baseline (BL), week 6 and week 12 for AUAss, simple uroflowmetry, postvoid residual volume (PVR), C-reactive protein (CRP), Short-Form 36 Health Survey (SF-36), and International Index of Erectile Function (IIEF). RESULTS:A total of 40 subjects completed the study. AUAss decreased 34.5% from BL to week 12 in the 1000 mg AMH group (p = 0.008). At week 12, CRP increased in the 500 mg AMH (p = 0.003) and placebo (p = 0.012) groups from their BL levels but not in the 1000 mg group. Average urine flow (Qmean) increased in the 500 mg (p = 0.033) and 1000 mg AMH (p = 0.002) groups versus placebo. PVR decreased in the 1000 mg AMH group (p = 0.034) from BL at week 6. Treatment group effects were observed for the physical functioning and sexual desire domains of the SF-36 and IIEF (p = 0.051 and p = 0.005 respectively). AMH was well tolerated. CONCLUSIONS:Oral administration of AMH improved LUTS and quality of life in as little as 6 weeks.
Very High Potency Preservation Rates in Young Men (< 60) After Radiation Therapy for Prostate Cancer [Meeting Abstract]