Safety and Efficacy of a Patient-Controlled Bladder Management System for Treating Urinary Retention in Men

The CymActive Bladder Management System (BMS) is a self-retaining catheter placed inside the urethra. It features a patient-controlled magnetic valve, enabling the bladder to fill and empty in cycles without the need for external devices. This study assessed the safety and effectiveness of the BMS in men experiencing urinary retention who required catheterization for more than 7 days. The study found the BMS to be potentially useful, convenient, and safe for appropriate patients with urinary retention. A follow-up study is planned to identify which patients benefit most from the device.

• 1
  Nine of 23 patients met all four criteria for the primary endpoint (successful placement, low post-void residual volume, no device-related adverse events requiring early removal, and successful removal).
• 2
  The I.U.C. was inserted successfully in 17 of 18 non-neurogenic patients and 5 of 5 SCI patients.
• 3
  Median PVR was 17 mL (range, 0 to 178).