Objectives To describe surgical complications in 597 women over a 24 month period following randomization to retropubic or transobturator midurethral slings. Study Designs During the Trial of Midurethral Sling (TOMUS) study, the DSMB regularly reviewed summary reports of all adverse events (AE) using the Dindo Surgical Complication Scale. Logistic regression models were created to explore associations between clinico-demographic factors and surgical complications. Results A total of 383 AEs were observed among 253 of the 597 women (42%). Seventy-eight AEs (20%) were classified as serious (SAE); occurring in 72 women. Intra-operative bladder perforation (15 events) occurred exclusively in the retropubic group. Neurologic adverse events were more common in the transobturator group than in retropubic (31 events versus 18 events, respectively). Twenty-three (4%) women experienced mesh complications, including delayed presentations, in both groups. Conclusions Adverse events vary by procedure, but are common after midurethral sling. Most events resolve without significant sequelae.

No abstract

Purpose Urodynamic studies have been proposed as a means of identifying patients at risk for voiding dysfunction following surgery for stress urinary incontinence We determined if preoperative urodynamic findings predict postoperative voiding dysfunction after pubovaginal sling and Burch colposuspension. Materials and Methods Data were analyzed from preoperative, standardized urodynamic studies performed on participants in the Stress Incontinence Treatment Efficacy Trial, in which women with stress urinary incontinence were randomized to undergo pubovaginal sling surgery or Burch colposuspension. Voiding dysfunction was defined as use of any bladder catheter after 6 weeks or reoperation for takedown of a pubovaginal sling or Burch colposuspension. Urodynamic study parameters studied were post void residual urine, maximum flow during non-invasive flowmetry, , maximum flow during pressure flow study (change in vesical pressure at maximum flow during pressure flow study, change in abdominal pressure at maximum flow during pressure flow study and change in detrusor pressure at maximum flow during pressure flow study. The study excluded women with preoperative post-void residual urine volume of more than > 150ml or maximum flow during noninvasive flowmetry of less than 12 ml per second unless advanced pelvic prolapse was also present. Results Of the 655 women in whom data was analyzed voiding dysfunction developed in 57 including 8 in Burch colposuspension and 49 in the pubovaginal sling groups. There were 9 patients who could not be categorized and , thus, were excluded from the remainder of the analyses (646). A total of 38 women used a catheter beyond week 6, 3 had a surgical takedown and 16 had both. All 19 women who had surgery takedown were in the pubovaginal sling group. The statistical analysis of urodynamic predictors is based on subsets of the entire cohort, including 579 with preoperative uroflowmetry, 378 women with change in vesical pressure, and 377 with change in abdominal and detrusor pressure values.. No pre-operative urodynamic study findings were associated with an increased risk of voiding dysfunction in any group. Mean maximum flow during noninvasive flowmetry values were similar among women with voiding dysfunction compared to those without voiding dysfunction in the entire group (23.4 vs. 25.7 ml per second, p=0.16), in the Burch colposuspension group (25.8 vs. 25.7ml per second, p=.98) and in the pubovaginal sling group (23.1 vs. 25.7ml per second, p=0.17). Voiding pressures and degree of abdominal straining were not associated with postoperative voiding dysfunction. Conclusions In this carefully selected group, preoperative urodynamic studies did not predict postoperative voiding dysfunction or the risk for surgical revision in the pubovaginal sling group. Our findings may be limited by our stringent exclusion criteria and studying a group believed to be at greater risk for voiding dysfunction could alter these findings. Additional analysis using subjective measures to define voiding d...

No abstract

No abstract