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

Abstract

Importance: Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data.

Objective: To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse.

Design, setting, and participants: This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. 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 and were followed up 5 years after their index surgery from April 2011 through June 2016.

Interventions: Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186).

Main outcomes and measures: The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-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. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300).

Results: The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, 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]). The estimated anatomic failure rate was 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]). 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, 2.4 [95% CI, -13.7 to 18.4]).

Conclusions and relevance: Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, 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 at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved.

Trial registration: clinicaltrials.gov Identifier: NCT01166373.

Figure 1.. Pelvic Organ Prolapse Quantification (POP-Q) Stages

The POP-Q points are used to assess a woman’s stage of pelvic organ prolapse on examination. The locations of these points are shown in panel A. This panel shows normal anatomy, most frequently seen in nulliparous women. In this trial, eligible patients included women planning vaginal surgery for stages 2 through 4 vaginal prolapse, illustrated in panel B. Descent of POP-Q point C with the Valsalva maneuver more than one-third of the total vaginal length and location of POP-Q points Aa, Ba, Ap, or Bp with the Valsalva maneuver beyond the hymen were among the criteria for surgical failure in this trial.

Figure 2.. Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) and Extended OPTIMAL Participant Flow^a

BPMT indicates behavioral therapy and pelvic floor muscle training; POP-Q, Pelvic Organ Prolapse Quantification System; SSLF, sacrospinous ligament fixation; ULS, uterosacral ligament suspension. ^aComplete CONSORT diagram can be found in the study by Barber et al. ^bA total of 77 had anatomic failure at 2 years in OPTIMAL, but only 76 attended the clinic visit; 1 had anatomic failure based on retreatment by 1 year. ^cRepresents a late 2-year visit excluded from original trial analysis but included for the extended trial.

Figure 3.. Kaplan-Meier Survival Curves for Failure of Vaginal Prolapse Surgery by Uterosacral Ligament Suspension or Sacrospinous Ligament Fixation in Treating Pelvic Organ Prolapse Through Year 5

A, The probability of surgical failure was defined as (1) Pelvic Organ Prolapse Quantification System (POP-Q) point C descended more than one-third of total vaginal length; (2) POP-Q points Aa, Ba, Ap, or Bp beyond the hymen; (3) bothersome bulge symptoms reported by the participant; or (4) the participant received retreatment. B, Probability of anatomic failure defined as POP-Q point C descended more than one-third of total vaginal length; POP-Q points Aa, Ba, Ap, or Bp beyond the hymen; or the participant received retreatment during follow-up. POP-Q points Aa and Ap are 3 cm proximal to or above the hymenal ring anteriorly and posteriorly, respectively. Points Ba and Bp are defined as the lowest points of the prolapse between Aa anteriorly or Ap posteriorly and the vaginal apex. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. C, Bothersome bulge symptoms were reported by the participant in response to the questions, “Do you usually have a sensation of bulging or protrusion from the vaginal area?” or “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?” on the Pelvic Floor Disorders Inventory. D, Probability of Retreatment for Pelvic Organ Prolapse. The + symbol represents a censored participant. SSLF indicates sacrospinous ligament fixation; ULS, uterosacral ligament suspension.