Exclusion criteria were known history of neurological disorder, urinary incontinence, Women who had recurrent urinary tract infections or positive urine culture (> [10.sup.5] colony-forming units of an identified single uro-pathogen per millilitre of urine) pre-operatively and women for whom a complicated procedure was encountered during the hysterectomy in which case in-dwelling catheter had to be kept post-operatively at the surgeon's decision.
Night Pouch System[TM] is a patented product that reportedly is easy to use and works with nearly all brands of night bags for urostomy and in-dwelling catheter patients.
In addition, the FDA and international regulators issue specific guidance for high-risk devices like artificial joints, coronary stents, in-dwelling catheters, pacer/defibrillators, and very extensive requirements for inhalers, patient monitors, infant incubators, prosthetic limbs, and wheelchairs.