Citations

Abstract Background A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie’s disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial. Aim To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854). Methods A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD. Outcomes The primary outcomes are safety, penile length, penile curvature, Peyronie’s Disease Questionnaire, International Index of Erectile Function, and satisfaction. Results 6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7–2.0 cm) and curvature improvements (18–20%). PTT-to-PTT men also achieved additional length (0.6–0.8 cm) without further curvature improvements. An as-treated analysis of PTT use ≥15 minute/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18–21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie’s Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0–2.2 cm), and 61% had curve improvements (16.8–21.4° [32.8–35.8%]). RestoreX was preferred 3–4:1 over all other PD treatments, and 100% preferred it over other PTT devices. Clinical Implications Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs. Strengths & Limitations Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3–9 hours) treatment arm. Conclusion PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD.

Abstract Aim Up to 10% of patients who undergo nonurological abdominopelvic operations suffer a ureteral injury. While preoperative ureteral stenting to facilitate identification of the ureter is common, it does not reduce the incidence of intraoperative ureteral injury and is not without risk. As we continue to broaden the application of minimally invasive surgical techniques, a new form of ureteral identification and avoidance that does not rely on tactile feedback is needed. We report our initial experience with intraureteral indocyanine green (ICG) for ureteral identification and avoidance during complex robotic‐assisted colorectal surgery. Method Patients undergoing adjunctive ureteral identification during robotic‐assisted colorectal surgery were prospectively identified. Each patient underwent intraureteral ICG administration using rigid cystoscopy (22 Fr). A 5‐Fr open‐ended ureteral catheter was inserted up to 20 cm and used to inject 5 ml of 2.5 mg/ml ICG as the catheter was withdrawn to the ureteral orifice. Intraureteral ICG was then detected using near‐infrared laser fluorescence technology (Firefly®). Results Successful ICG‐enhanced ureteral identification and avoidance was performed in 15 of 16 (94%) patients undergoing robotic‐assisted colorectal surgery. The median ICG instillation time was 11.5 min (range 4–21 min) and the median operative time with ICG visualization was 489 min (8 h 9 min) [range 268–738 min (4 h 28 min–12 h 18 min)]. No patient experienced intraoperative ureteral injury and there were no adverse sequelae or complications associated with intraureteral ICG administration. Conclusion Intraureteral ICG is a safe and effective method of intraoperative ureteral identification and avoidance during complex robotic‐assisted colorectal surgery. Precise and prolonged ureteral visualization was achieved, allowing for long operative times compatible with complex robotic‐assisted operations.

Background In epidemiologic studies, obesity has been associated with reduced natriuretic peptide ( NP ) concentrations. Reduced NP production could impair the ability of obese individuals to respond to salt loads, increasing the risk of hypertension and other disorders. We hypothesized that weight loss enhances NP production before and after salt loading. Methods and Results We enrolled 15 obese individuals (mean BMI 45±5.4 kg/m 2 ) undergoing gastric bypass surgery. Before and 6 months after surgery, subjects were admitted to the clinical research center and administered a large‐volume intravenous saline challenge. Echocardiography and serial blood sampling were performed. From the pre‐operative visit to 6 months after surgery, subjects had a mean BMI decrease of 27%. At the 6‐month visit, N‐terminal pro‐atrial NP (Nt‐pro ANP ) levels were 40% higher before, during, and after the saline infusion, compared with levels measured at the same time points during the pre‐operative visit ( P <0.001). The rise in Nt‐pro‐ ANP induced by the saline infusion (≈50%) was similar both before and after surgery (saline, P <0.001; interaction, P =0.2). Similar results were obtained for BNP and Nt‐pro BNP ; resting concentrations increased by 50% and 31%, respectively, after gastric bypass surgery. The increase in NP concentrations after surgery was accompanied by significant decreases in mean arterial pressure ( P =0.004) and heart rate ( P <0.001), and an increase in mitral annular diastolic velocity ( P =0.02). Conclusion In obese individuals, weight loss is associated with a substantial increase in the “setpoint” of circulating NP concentrations. Higher NP concentrations could contribute to an enhanced ability to handle salt loads after weight loss.