ABSTRACT
INTRODUCTION AND OBJECTIVE: We performed a shamcontrolled, randomized prospective trial in men with ED using an electrohydraulic shockwave device FDA cleared for connective tissue activation and improved blood flow. METHOD(S): This single-blind study was performed in men with ED naive to acoustic wave and shockwave therapy. Patients were randomized to treatment and assigned to active low intensity shockwave therapy (LiSWT) (4 Hz, 0.12 mJ/mm2) or sham treatment, 2:1. Arm 1 consisted of 3 treatments of 5000 shocks every 3 weeks. Arm 2 consisted of 5000, 3000, and 3000 shocks during weeks 1, 2, and 3, respectively, followed by an identical cycle of treatment 3 weeks later. Doppler ultrasound and grayscale imaging with a 15.4 MHz probe were performed under pharmacologic erection at weeks 20 and 32. Subjects completing sham treatment were unblinded and crossed over to the opposite arm for active treatment. Post-treatment end diastolic velocity (EDV) and peak systolic velocity (PSV) were measured, and visual grading scores were used to assess extent of hypoechoic regions in the corpora cavernosa. Data were analyzed by 2-way repeated measures ANOVA with Geisser-Greenhouse correction. Pairwise comparisons were performed to baseline used Dunnett's multiple comparison test. Missing data were imputed by "last observation carried forward". RESULT(S): Although powered for 60, recruitment was limited due to COVID and 36 subjects (22 active, 14 sham) were randomized. Sham treatments showed no significant changes in outcome measures. The number of subjects with improved visual grading scores in the proximal region was consistently higher in active LiSWT vs sham (Arm 1=88.9% vs. 11.1%;Arm 2=40.0% vs. 20.0%, respectively) with statistical significance in Arm 1 at weeks 20 (p=0.005) and 32 (p=0.001). Sham subjects rolled over to active LiSWT also had improved grayscale ratings (Arm 1=33.3% vs. 11.1%;Arm 2=40.0% vs. 20.0%). After LiSWT, greater numbers of patients had higher PSV, lower EDV, or no worsening of blood flow parameters relative to baseline. Decrease in EDV was statistically significant in active treatment Arm 2 at Week 32 (p=0.003). Mean IIEF-EF scores were nominally higher in subjects in active treatment who had improved visual grading scores vs those with no improvement. Adverse events were transient. CONCLUSION(S): Flaccid penile LiSWT appears to be safe and efficacious for treating ED based on statistically significant changes from baseline between sham and active treatments in primary outcome measures.
ABSTRACT
Purpose : Dry age-related macular degeneration (AMD) is a leading contributor to visual impairment across the globe. No current treatment exists to improve visual function or reduce disease progression outside of vitamin supplementation and lifestyle changes. LIGHTSITE III is evaluating multiwavelength photobiomodulation (PBM) therapy using the LumiThera Valeda® Light Delivery System in dry AMD Methods : LIGHTSITE III (NCT04065490) is a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of PBM in dry AMD. Target enrollment was approximately 96 subjects (144 eyes). Subjects are treated with six series of PBM/Sham treatments (3x per week for 3 weeks) delivered over a 24-month period with a 13-month efficacy analysis of data. PBM therapy consists of low-level light exposure to selected tissues resulting in positive effects on mitochondrial output and improvement in cellular activity. Valeda is used to deliver multiwavelength PBM treatment using 590, 660 and 850 nm of light. Subjects are assessed for clinical and safety outcomes (i.e., best-corrected visual acuity (BCVA), low- luminance BCVA, contrast sensitivity, reading speed, color vision, VFQ-25 and perimetry). Independent OCT, FAF and color fundus imaging outcomes at selected timepoints are analyzed by a masked imaging reading center Results : A total of 148 eyes from 100 subjects with dry AMD have been enrolled and randomized in a 2:1 design (PBM:Sham). The majority of subjects are female (68%) and Caucasian (99%). The average age at enrollment was 75 years and mean time since dry AMD diagnosis is 4.9 years. COVID-19 interference has been minimal and not significantly impacted subject enrollment or retention. Clinical and anatomical outcome data from the interim analysis conducted at Month 13 is presented. Results from the 21-month time point are expected at end of 2022 Conclusions : LIGHTSITE III provides the largest, randomized controlled trial evaluating the effects of PBM in dry AMD subjects. PBM therapy may offer a new treatment strategy with a unique mechanism and modality for patients with dry AMD.
ABSTRACT
Introduction: Obesity is an important risk factor associated with poor cardiovascular outcomes. Lifestyle modification, pharmaceutical, and intragastric balloons weight loss therapy are often unsuccessful, unsustainable, or accompanied by risks. Transcatheter bariatric embolotherapy (TBE) is a promising therapy in which the left gastric artery is embolized to reduce the expression of “hunger” hormones from the gastric fundus. Despite several early clinical trials, long-term safety or efficacy has yet to be studied. We originally studied TBE in a double-blind, sham procedure, first in human RCT of 40 obese patients (pts) (NCT03185949). Complete details regarding the initial RCT were previously published, briefly the study demonstrated up to 9.3% TBWL at 1-year post-TBE. Following completion of the initial study at 1 year followup, we asked subjects to return for long-term evaluation. Methods: Subjects who previously completed the RCT with no major protocol deviations were asked to return for SOC follow-up visits at 2-, 2.5-, and 3-years post-embolization for further evaluation on weight loss, blood pressure, pre-diabetic clinical status, satiety, and Quality of Life (QoL). Given the evolving situation of the COVID-19 pandemic, the study site was unable to complete all planned study visits. Results: Between 2-3 years post-TBE subjects (n=11) demonstrated a mean 9% TBWL and 25% EBWL. This cohort of patients demonstrated a long-term weight loss maintenance, with previously reported weight loss of 8% TBWL at 1-year post-embolization. Overall QoL at 2 years postTBE increased by approximately 22%. The volume to achieve satiety was reduced by 33% in long-term follow-up. Oral Disposition Index increased from 1.89 mM at 6 months post-TBE to 4.41 mM 2 years postTBE. 1-hr Oral Glucose Tolerance Test (OGTT) C-Peptide levels decreased from 3.22 nmol/L at 6 months to 2.53 nmol/L at 2 years post-TBE. 2-hr OGTT C-Peptide levels also showed a decrease from 2.95 nmol/L at 6 months to 1.78 nmol/L at 2 years post-TBE, possibly indicating an improvement in pre-diabetic status. Conclusions: Bariatric embolization is safe and when used along with lifestyle therapy, results in clinically significant and sustained weight loss up to 2-3 years post-TBE.