Apical prolapse, a prolapse of the upper vaginal walls that can lead to urinary incontinence, can be corrected with either of two transvaginal surgical approaches: sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (ULS). The Operations and Pelvic Muscle Training in the Management of Apical Support Loss trial is the first randomized study to compare two-year postprocedural outcomes of each approach and the impact of perioperative behavioral therapy with pelvic floor-muscle training (BPMT) on reported urinary symptoms.
The five-year study involved nine U.S. institutions that were all members of the Pelvic Floor Disorders Network. Women with vaginal or uterine prolapse at stages 2 to 4, 374 subjects in total, were randomized in two ways: according to procedure type (186 undergoing SSLF and 188 undergoing ULS) and by receipt of either perioperative BPMT (186 patients) or usual care (188 patients). The follow-up rate was 84.5% at two years after surgery.
Surgical success was defined as no descent of the vaginal apex more than a third of the way into the vaginal canal, no anterior or posterior vaginal wall drop beyond the hymen, no reported problems with vaginal bulging, and no need for retreatment. On these measures, the success rate with ULS was 59.2%, compared with 60.5% with SSLF. No significant differences in other outcomes, such as length of hospitalization, blood loss, surgical time, and postoperative treatment, were seen. Serious adverse events, most often intraoperative bladder perforation or vaginal-tissue granulation, occurred at nearly the same rate in the two groups (ULS, 16.5%; SSLF, 16.7%). Neurologic pain occurred more frequently with SSLF-12.4%, compared with 6.9% with ULS-and continued in 4.3% of the SSLF patients for at least four to six weeks.
BPMT hadn't delivered any significant improvements in perceived urinary symptoms at either the six-month mark or the two-year mark. These results suggest that pelvic floor-muscle training might not be helpful in this patient population.
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