Jelovsek JE, et al. - Experts compared outcomes in women randomized to uterosacral ligament suspension (ULS) or sacrospinous ligament fixation (SSLF) and usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse. At 5 years, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores, in women who underwent vaginal surgery for apical pelvic organ vaginal prolapse was noted. Nonetheless, prolapse symptom scores remained improved, rates of surgical failure increased during the follow-up period compared with outcomes at 2 years.

Methods

• Authors conducted this 2 × 2 factorial randomized clinical trial at 9 US medical centres.
• They followed up the eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 for 5 years after their index surgery from April 2011 through June 2016.
• The interventions included 2 randomizations: BPMT (n = 186) or usual care (n = 188) and surgical intervention (ULS: n = 188 or SSLF: n = 186).
• Time to surgical failure was the primary surgical outcome.
• Researchers defined the surgical failure as (1) apical descent greater than 1-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms.
• Time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300) were the primary behavioral outcomes.

Results

• Findings suggested that the original study randomized 374 patients, of whom 309 were eligible for this extended trial.
• As per data, for this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial.
• The estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]) by year 5.
• Results demonstrated the estimated anatomic failure rate to be 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]).
• Researchers noted that the improvements in Pelvic Organ Prolapse Distress Inventory scores in the BPMT were -59.4 group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]).