Adjustable Transobturator Male System after Failed Surgical Devices for Male Stress Urinary Incontinence: A...

Area of Science:

• Urology
• Medical Devices
• Surgical Innovation

Background:

• Male stress urinary incontinence (SUI) significantly impacts quality of life.
• Previous surgical interventions for SUI, such as artificial urinary sphincter (AUS), Advance, and Virtue systems, have variable success rates.
• A need exists for effective and safe treatment options for patients with persistent SUI after initial device implantation.

Purpose of the Study:

• To assess the feasibility, efficacy, and safety of the Adjustable Transobturator Male System (ATOMS) in men with SUI.
• To evaluate ATOMS performance in patients with a history of failed surgical devices for SUI.
• To determine patient satisfaction and complication rates associated with ATOMS implantation.

Main Methods:

• A feasibility study involving 30 male patients previously treated with other surgical devices for SUI.
• Evaluation of SUI severity using pad-test and pad-count pre- and post-ATOMS adjustment.
• Monitoring of operative parameters, patient satisfaction, and complication incidence and severity.

Main Results:

• Significant reduction in median pad-test from 435 mL to 10 mL and pad-count from 4 to 0 post-adjustment.
• High success rate with 76.7% achieving dryness and 83.3% patient satisfaction.
• Low complication rate (13.3%) with no cases of urinary retention, infection, or urethral erosion; one device removed for inefficacy.

Conclusions:

• The ATOMS is a feasible and effective alternative for managing male SUI in patients with prior failed treatments.
• High patient satisfaction and a favorable safety profile, including the absence of erosion and infection, support ATOMS as an attractive option.
• ATOMS demonstrates potential as a valuable treatment for complex SUI cases refractory to other surgical interventions.