NEW ORLEANS, LA USA (UroToday.com) - Despite limited high-grade evidence in the literature, it is not unusual for some patients with urinary incontinence refractory to conservative measures and medical management to undergo transection of the filum terminale despite normal neuroanatomic imaging. Due to the significant controversy this treatment has generated, a group of pediatric urologists in Canada attempted to subject this notion to rigorous study with a randomized, controlled pilot study. The resulting abstract won the SPU clinical research prize.
The study plan was generated in 2004 with enrollment taking place between 2006-2010. The stated hypothesis was that refractory dysfunction elimination would be more responsive to section of the filum terminale plus symptomatic medical management versus medical treatment alone. The group used 3 validated instruments: a previously published standardized urodynamics score (UDS), dysfunctional elimination score (DES), and the PEMQOL (Pediatric Enuresis Module to assess Quality of Life).
Patients between 5-18 years of age with primary or secondary incontinence refractory to medical management for more than 1 year were included in the study. Patients were also required to have an abnormal voiding diary, abnormal UDS and DES scores, a normal spine MRI with normal conus position at L2 and a normal renal and bladder ultrasound with a minimum of one year of follow-up. Patients were excluded if they had other anatomic abnormalities (anorectal malformations, dysraphism), atonic bladder, cognitive impairment, or a neurologic disorder. The study enrolled a total of 21 patients. The authors acknowledged that the full study would require 1 400 patients in order to be adequately powered.
UDS, DES and PEMQOL scores were compared at the start of the study and one year after surgical treatment or medical management. Although there were slight changes in the scores before and after treatment, the differences between and within groups were not statistically significant. Thus, the authors conclude that section of the filum terminale likely adds no additional benefit to the treatment of these children and casts doubt on the existence of occult tethered cord syndrome. They recognize that the study was not adequately powered to truly detect a difference, and thus the results may be the result of chance. However, conducting a full, randomized, controlled trial of that magnitude is simply not feasible.
Presented by Andrew MacNeily at the American Urological Association (AUA) Annual Meeting - May 15 - 19, 2015 - New Orleans, LA USA
Vancouver, BC CANADA
Reported by Michaella M. Prasad, MD (Medical University of South Carolina, Charleston, SC USA), medical writer for UroToday.com