HOLLYWOOD, FLA. — More adverse gastrointestinal events and wound complications may be in store for women who undergo stress incontinence surgery and other procedures concomitantly, according to findings reported at the annual meeting of the American Urogynecologic Society.
“While [we would expect] to see more frequent adverse events occurring in patients with concomitant surgeries as compared to those who underwent index surgeries only, we wanted to determine which organ systems were more affected by concomitant surgery,” said Dr. Toby Chai, a professor in the urology department at the University of Maryland, Baltimore.
Other types of surgery included posterior colporrhaphy, sacrospinous ligament suspension, uterosacral ligament suspension, sacrocolpopexy, enterocele repair, and hysterectomy.
Previous results from the Stress Incontinence Surgical Treatment Efficacy (SISTEr) trial found an overall success rate of 47% with the autologous rectus fascial sling procedure versus a 38% rate of success with the Burch colposuspension after 24 months (N. Engl. J. Med. 2007;35:2198–200).
Stress-type symptoms of urinary incontinence improved for 66% of the sling group, compared with 49% for the Burch group, a significant difference. However, women in the sling group reported more urinary tract infections, difficulty with voiding, and urge incontinence.
Dr. Chai and his associates conducted a second study as part of the SISTEr trial to assess these adverse events further. They found that only wound and gastrointestinal complications had statistically higher rates in the concomitant surgical group at 2 years. There were 7 GI complications in the Burch group and 8 in the sling group, all in women who had undergone another procedure; a total of 24 wound complications occurred, 13 in the Burch group, and 11 in the sling group. Of the 24 events, 22 occurred in the concomitant surgery group.
Up to postoperative week 6, there were 91 reports of cystitis among the 326 women who had a sling procedure, compared with 39 reports among the 329 others who had a Burch procedure. This increased infection rate was associated with a higher rate of clean intermittent self-catheterization (CISC) in the sling group.
At 2 years, there were a total of 290 cystitis events in the sling group, compared with 206 in the Burch group. “Interestingly, genitourinary complications, including cystitis, were not statistically different between those with and those without concomitant surgeries,” Dr. Chai said in an interview.
“We were surprised by the number of patients, even in the Burch arm, that had cystitis episodes. We of course do not know the preoperative cystitis rate in our population. It is unlikely that this rate was as high as 8%–10%,” he stated, adding that a relatively high number of these patients are treated with oral antibiotics beyond the typical postoperative period.
“The take-home message is that adverse events after Burch and sling are relatively uncommon, except for symptoms of cystitis,” Dr. Chai said.
Investigators at each study site were required to report complications. Therefore, one possible limitation of the study is that adverse event rates were not based on a chart review. Also, cystitis was defined not by a positive urine culture, but by clinical symptoms suggestive of a urinary tract infection that led to an antibiotic prescription.
Whether prophylactic antibiotics will reduce the prevalence of cystitis remains to be seen, Dr. Chai said. In the future, a randomized trial to assess prophylactic antibiotics among patients who require CISC after the sling procedure might be beneficial. However, “there are insufficient data currently to recommend routine antibiotic prophylaxis in all patients who start self-catheterization,” he said.
“Overall, the surgeries are safe and … patients have to balance the risk of these minor complications against their decreased quality of life from stress urinary incontinence,” Dr. Chai concluded.