Results From the OPTIMAL Trial Five Years Out: Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation for Prolapse?
BACKGROUND AND PURPOSE:
The original Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study provided 2-year outcomes in women undergoing vaginal apical prolapse repair with midurethral sling for stress urinary incontinence
There were no significant differences between surgical intervention with either sacrospinous ligament fixation (SSLF) or uterosacral ligament vaginal vault suspension (ULS)
Jelovsek et al. (JAMA 2018) provide the results from Extended-OPTIMAL study which provides 5-year follow up and assesses the efficacy of
Uterosacral ligament suspension (ULS) vs. sacrospinous ligament fixation (SSLF)
Perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse
Multi-centered randomized clinical trial
5 year follow up of the OPTIMAL trial
Participants: Women going for planned surgery for stage 2 to 4 prolapse, vaginal bulge symptoms, descent of the uterus or vaginal apex at least halfway into the vagina, stress urinary incontinence symptoms, and objective demonstration of stress incontinence by office or urodynamic testing in the previous 12 months
Patients either received
BPMT or usual care
Surgical intervention (USL or SSLF)
Primary surgical outcome was time to surgical failure
Surgical failure was defined as
Apical descent greater than 1/3 of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse
Bothersome bulge symptoms
Primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300)
244 (86%) patients completed the extended trial
BMPT (n = 186); Usual care (n= 188); ULS(n=188); SSLF(n=186)
By year 5, the estimated surgical failure rate was
61.5% in the ULS group and 70.3% in the SSLF group
Adjusted difference was not significant
The estimated anatomic failure rate was
45.6% in the BPMT group and 47.2% in the usual care group
Adjusted difference was not significant
Improvements in Pelvic Organ Prolapse Distress Inventory scores were
~59.4 in the BPMT group and ~61.8 in the usual care group
Adjusted mean difference was not significant
Surgical failure was not different between ULS and SSLF
Anatomic success and symptom scores were not different between usual care and BMPT
Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period; however, prolapse symptoms scores remained improved
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