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

Area of Science:

• Urology
• Medical Devices
• Minimally Invasive Surgery

Background:

• Stress urinary incontinence (SUI) significantly impacts millions globally, affecting quality of life and healthcare costs.
• Current treatments for severe SUI often involve invasive extraurethral artificial sphincters.

Purpose of the Study:

• To evaluate the efficacy and safety of a novel, minimally invasive endourethral device for SUI treatment.
• To assess improvements in continence and patient quality of life following device implantation.

Main Methods:

• Ten patients with SUI underwent implantation of the endourethral device across three Italian centers.
• Device position was confirmed via ultrasonography; continence and quality of life were assessed using pad-tests, ICI-Q, and custom checklists.
• The device was explanted after 90 days.

Main Results:

• Successful implantation and explantation were achieved in 8 out of 10 patients.
• Significant improvements observed: 82% median improvement in continence and 61% mean reduction in quality of life impact.
• The procedure was well-tolerated, with no major pain or discomfort reported.

Conclusions:

• The endourethral artificial sphincter is effective for treating SUI.
• The device offers a minimally invasive option with a short implantation time and no significant side effects.