PURPOSE: We determined the clinicodemographic factors associated with complications of continence procedures, the impact of concomitant surgery on the complication rate and the relationship between the incidence of cystitis and the method of postoperative bladder drainage. MATERIALS AND METHODS: We reviewed serious adverse events and adverse events in the Stress Incontinence Surgical Efficacy Trial, a randomized trial comparing Burch colposuspension to the autologous rectus fascial sling. Clinicodemographic variables were analyzed to determine those associated with adverse events using logistic regression analysis. Complications were stratified based on the presence or absence of concomitant surgery. Differences in complication rates (controlling for concomitant surgery) and cystitis rates (controlling for the bladder emptying method) were compared using Fisher's exact test. RESULTS:Blood loss (p = 0.0002) and operative time (p <0.0001) were significantly associated with an adverse event. Patients who underwent concomitant surgery had a significantly higher serious adverse event rate (14.2% vs 7.3%, p = 0.01) and adverse event rate (60.5% vs 48%, p <0.01) than patients who underwent continence surgery alone. Cystitis rates were higher in the sling vs the Burch group up to 6 weeks postoperatively regardless of concomitant surgery status (p <0.01). Intermittent self-catheterization increased the cystitis rate by 17% and 23% in the Burch and sling groups, respectively. CONCLUSIONS: Concomitant surgery at continence surgery increased the risk of complications. Sling surgery was associated with a higher risk of cystitis within the first 6 weeks postoperatively. Intermittent self-catheterization increased the risk of cystitis in each group. Complications were associated with surgical factors and not with patient related factors.
RCT Entities:
PURPOSE: We determined the clinicodemographic factors associated with complications of continence procedures, the impact of concomitant surgery on the complication rate and the relationship between the incidence of cystitis and the method of postoperative bladder drainage. MATERIALS AND METHODS: We reviewed serious adverse events and adverse events in the Stress Incontinence Surgical Efficacy Trial, a randomized trial comparing Burch colposuspension to the autologous rectus fascial sling. Clinicodemographic variables were analyzed to determine those associated with adverse events using logistic regression analysis. Complications were stratified based on the presence or absence of concomitant surgery. Differences in complication rates (controlling for concomitant surgery) and cystitis rates (controlling for the bladder emptying method) were compared using Fisher's exact test. RESULTS:Blood loss (p = 0.0002) and operative time (p <0.0001) were significantly associated with an adverse event. Patients who underwent concomitant surgery had a significantly higher serious adverse event rate (14.2% vs 7.3%, p = 0.01) and adverse event rate (60.5% vs 48%, p <0.01) than patients who underwent continence surgery alone. Cystitis rates were higher in the sling vs the Burch group up to 6 weeks postoperatively regardless of concomitant surgery status (p <0.01). Intermittent self-catheterization increased the cystitis rate by 17% and 23% in the Burch and sling groups, respectively. CONCLUSIONS: Concomitant surgery at continence surgery increased the risk of complications. Sling surgery was associated with a higher risk of cystitis within the first 6 weeks postoperatively. Intermittent self-catheterization increased the risk of cystitis in each group. Complications were associated with surgical factors and not with patient related factors.
Authors: R G Rogers; U Lebküchner; D N Kammerer-Doak; P K Thompson; M D Walters; I E Nygaard Journal: Am J Obstet Gynecol Date: 2006-10-02 Impact factor: 8.661
Authors: Sara L Jackson; Edward J Boyko; Delia Scholes; Linn Abraham; Kalpana Gupta; Stephan D Fihn Journal: Am J Med Date: 2004-12-15 Impact factor: 4.965
Authors: Michael E Albo; Holly E Richter; Linda Brubaker; Peggy Norton; Stephen R Kraus; Philippe E Zimmern; Toby C Chai; Halina Zyczynski; Ananias C Diokno; Sharon Tennstedt; Charles Nager; L Keith Lloyd; MaryPat FitzGerald; Gary E Lemack; Harry W Johnson; Wendy Leng; Veronica Mallett; Anne M Stoddard; Shawn Menefee; R Edward Varner; Kimberly Kenton; Pam Moalli; Larry Sirls; Kimberly J Dandreo; John W Kusek; Leroy M Nyberg; William Steers Journal: N Engl J Med Date: 2007-05-21 Impact factor: 91.245