Safety and efficacy of a patient-controlled bladder management system for treating urinary retention in men

Abstract

Aims: The CymActive™ Bladder Management System (BMS) is a self-retaining, intraurethral catheter with a patient-controlled magnetic valve that allows cyclical bladder filling and emptying, without external appliances. We determined the safety and efficacy of the BMS in men with urinary retention who required catheterization for more than 7 days.

Methods: Men requiring continuous drainage, bladder capacity less than 300 ml, history of prostatic or urethral surgery, or urethral length outside of defined limits, were excluded. Data were collected from patient diaries and weekly visits during catheterization for up to 30 days. The primary composite endpoint assessed four outcomes: placement, post-void residual volume (PVR) of 75 ml or less, adverse device-related events requiring early removal, and removal.

Results: Nine of 23 patients met all four criteria: eight of 18 non-neurogenic (7/11 prior Foley users and 1/7 without Foley experience) and one of five neurogenic spinal cord injury (SCI) patients. Secondary outcomes in non-neurogenic patients included: 17/18 successful insertions; of these, 16/17 average PVR of 75 ml; successful valve openings and closings ≥ 95% of more than 1,400 voids; and minimal leakage. Four of five SCI patients discontinued within 7 days. Cystourethroscopy after removal revealed no marked inflammation or mucosal changes.

Conclusions: This pilot study demonstrated the BMS is potentially useful, convenient, and safe for appropriate patients. A follow-up study will better define the characteristics of patients who benefit from this device and examine whether the use of antimuscarinic agents improves outcomes. Neurourol. Urodynam. 35:630-635, 2016. © 2015 Wiley Periodicals, Inc.

Keywords: bladder outlet obstruction; quality of life; urinary bladder control; urinary bladder drainage; urinary catheters; urinary retention; urinary tract infections.

Figure 1

A. The CymActive™ I.U.C. is a soft, thin walled, silicone intraurethral catheter with a relatively large lumen. Laboratory tests of the I.U.C. (hydrostatic pressure of 40 cm water) measured a flow rate of about 6.4 mL/sec, a rate similar to those measured under identical conditions for commercial intermittent catheters (Mentor Self-Cath 12 Fr = 7.3 mL/sec; Kendall Dover red rubber 16 Fr = 6.31 mL/sec). Figure 1B. The CymActive™ I.U.C. is packaged locked onto an integrated Inserter that mirrors the process for inserting a Foley catheter. When the I.U.C. is in place, the Inserter is disengaged and removed.

Figure 2

A Malecot retains the CymActive I.U.C. in the bladder and a magnetic valve (UroValve™) at the distal end controls urinary flow. The one moveable piece in the valve is a samarium cobalt magnetic sphere that is held to the valve seat by attraction to a ferrous ring. The patient holds the Actuator magnet near the scrotum to open the valve, and moves the actuator magnet away to allow the valve to close. Extraction tethers at the distal end of the catheter may be allowed to extend beyond the tip of the penis for easy removal or may be trimmed to end inside the penile meatus. (Image © 2010 Golgeon Group, Inc.).