A randomized controlled trial comparing a modified Burch procedure and a suburethral sling: long-term follow-up
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 19 participants or records.
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