Transurethral Renal Pelvic Denervation: A Feasibility Trial in Patients with Uncontrolled Hypertension

Abstract

Background: Endovascular renal denervation reduces blood pressure (BP). We explored an alternative approach to renal denervation using radiofrequency energy delivered across the renal pelvis utilizing the natural orifice of the urethra and the ureters. Methods: This open-label, single-arm feasibility study enrolled patients with uncontrolled hypertension despite antihypertensive drug therapy. The primary effectiveness endpoint was the change in ambulatory daytime systolic BP (SBP) 2 months following renal pelvic denervation. Results: The 18 patients (mean age 56±12 years) enrolled were taking an average of 2.7 antihypertensive drugs daily. Renal pelvic denervation reduced mean daytime SBP by 19.4 mm Hg (95% CI, -24.9 to -14.0, P<0.001) from its baseline of 148.4±8.7 mm Hg. Mean nighttime (-21.4 mm Hg [95% CI, -29.5 to -13.3]) and 24-hour (-20.3 mm Hg [95% CI, -26.2 to -14.5]) SBP each fell significantly (P<0.001) as did the corresponding diastolic BPs (P<0.001). Office SBP decreased from 156.5±12.3 mm Hg by 22.4 mm Hg (95% CI, -31.5 to -13.3, P<0.001) by 2 months. Office SBP decreased over time (P=0.001 by linear trend test) starting by day 1 with a decrease of 8.3 mm Hg (95% CI, -16.9 to 0.3, P=0.057). There were no serious adverse events. Mild transitory back pain followed the procedure. Serum creatinine decreased by 0.08 mg/dL (P=0.02) and estimated glomerular filtration rate increased by 7.2 mL/min/1.73m2 (P=0.03) 2 months following ablation procedure. Conclusions: Based on these initial findings, a well-powered, sham-controlled trial of renal pelvic denervation to more fully establish its safety and effectiveness is now justified in patients with uncontrolled hypertension despite drug therapy. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05440513.