A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-term follow-up.

The aim of this study was to compare the long-term results of a modified Burch procedure with a sling procedure for the treatment of stress incontinence with a low-pressure urethra. Thirty-six women with urodynamic stress incontinence, low-pressure urethra, urethral hypermobility and no significant pelvic organ prolapse were randomly assigned to undergo either a modified Burch procedure ( n=19) or a sling placement ( n=17). Cure of the stress incontinence (defined as a negative stress test and negative pad-weight test) was the primary long-term endpoint. Secondary endpoints included subjective cure of stress incontinence (defined as no incontinence episodes on a 1-week voiding diary) and voiding function studies. Comparisons of group means were performed with the Mann-Whitney U-test, pooled variance t-tests and separate variance t-tests. Proportions were compared with Fisher's exact test. A logistic regression analysis was performed to control for covariates that differed in our two groups despite randomization. Long-term follow-up (mean=72.6 months) was available for 82% (28/34) of the original study group. The objective cure rates for the Burch and sling groups were 84.6% and 100%, respectively ( P=0.17). Mean uroflowmetry rates for the Burch and sling groups were 7.38 and 6.8 ml/s, respectively ( P=0.58, 95%CI -2.5, 4.4). Mean postvoid residual volumes for both groups were 35 ml ( P=0.97, 95% CI -23.8, 65.9). Two sling patients (12%) required partial resection of their slings because of erosion. Both patients remained continent. In terms of voiding function and stress incontinence cure, there were no differences between groups undergoing modified Burch or sling procedures for treatment of urodynamic stress incontinence with low-pressure urethra.

RCT Entities:   Population Interventions Outcomes