Urinary Continence Restoration Through an Endourethral Device: A 3-Month Pilot Study on 10 Patients.

Background: Stress urinary incontinence (SUI) is a widespread and frustrating condition that affects millions of people worldwide, with severe consequences on patients' quality of life and health care systems' costs. Currently, the most severe cases of SUI are treated using implanted (and rather invasive) extraurethral artificial sphincters. The authors propose an innovative, minimally invasive endourethral device for the treatment of SUI. Methods: Ten patients with SUI were enrolled in three Italian centers and underwent device implantation. After 10, 30, 60, and 90 days, correct device position was confirmed by ultrasonography. Improvements in continence and quality of life were evaluated through a 24-hour pad-test, an International Consultation on Incontinence Questionnarie-Short Form (ICI-Q) and a custom checklist. The device was explanted after 90 days. Results: The proposed device was successfully implanted and explanted in 8 out of 10 patients. The results of the pad-test, ICI-Q, and custom checklist demonstrated remarkable improvements in continence (median improvement: 82% with respect to the initial condition) and quality of life (mean reduction of the impact of urine losses on the quality of life: 61%). No major pain or discomfort was reported. Conclusions: The results demonstrate the efficacy of the proposed endourethral artificial sphincter in addressing SUI. The proposed device was successfully implanted and explanted in a short time (∼10 minutes) without intrinsic side effects and without triggering pain or discomfort.