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

METHODS:

• 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)

RESULTS:

• 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

CONCLUSION:

• 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

Learn More – Primary Sources:

Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial

Related ObG Topics:

Mesh and Pelvic Organ Prolapse: ACOG Practice Advisory & ACOG/AUGS Recommendations 

Robotic vs Vaginal vs Open Surgery for Vaginal Prolapse – How Do They Compare?

What is the Best Approach to Repair Vaginal Vault Prolapse following Hysterectomy?

Is Pelvic Muscle Strengthening Effective Following Pelvic Surgery for Prolapse and Incontinence?