title: Safety and efficacy of a patient-controlled bladder management system for treating urinary retention in men.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: Ingenion Medical Limited, London, United Kingdom.
authors: Harvey D
authors: HD
authors: Homan
authors: Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
authors: Roger
authors: R
authors: Dmochowski
authors: Urology Clinics of North Texas, Dallas, Texas.
authors: James S
authors: JS
authors: Cochran
authors: The Urology Center of Colorado, Denver, Colorado.
authors: Lawrence
authors: L
authors: Karsh
authors: Premier Urology Group-Urological Surgery Associates, Edison, New Jersey.
authors: Neil D
authors: ND
authors: Sherman
authors: Department of Urology, Harvard Medical School, VA Boston Healthcare System, Boston, Massachusetts.
authors: Subbarao
authors: S
authors: Yalla
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006801:Humans; D008297:Male; D008875:Middle Aged; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D011446:Prospective Studies; D012648:Self Care; D016896:Treatment Outcome; D014521:Urethra; D001750:Urinary Bladder, Neurogenic / Q000150:complications; D014546:Urinary Catheterization; D062885:Urinary Catheters; D016055:Urinary Retention / Q000209:etiology / Q000628:therapy*
keywords: bladder outlet obstruction; quality of life; urinary bladder control; urinary bladder drainage; urinary catheters; urinary retention; urinary tract infections