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

Neurourology and urodynamics

PubMedID: 25856157

Homan HD, Dmochowski R, Cochran JS, Karsh L, Sherman ND, Yalla S. Safety and efficacy of a patient-controlled bladder management system for treating urinary retention in men. Neurourol Urodyn. 2015;.
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. © 2015 Wiley Periodicals, Inc.