Postoperative pain and the need for intervention after sacrospinous ligament hysteropexy compared to colpopexy: a retrospective cohort study.

OBJECTIVES: To compare postoperative pain between patients undergoing sacrospinous ligament colpopexy (SSLF) and hysteropexy (SSLH). METHODS: This was a retrospective cohort study of all patients undergoing native tissue SSLF and SSLH between January 2013 and March 2020. The electronic medical record was queried for demographic and perioperative data until the postoperative visit. The primary outcome was a composite incidence of any of the following: telephone calls, urgent office visits, additional analgesic prescriptions and need for intervention for pain in the buttocks, posterior thigh or perirectal area. Secondary outcomes were the incidence of persistent pain at the postoperative visit and perioperative risk factors associated with reported pain. RESULTS: A total of 406 patients met inclusion criteria (308 SSLF, 98 SSLH). The composite pain outcome was seen in 99 patients (24.4%; 95% CI 20.5%-28.8%), and there was no statistical difference between cohorts. Persistent pain was seen in 15.6% and 13.3% of SSLF and SSLH patients at 6 weeks (p = 0.58). Twelve patients (3.0%) underwent interventions for pain, including physical therapy (2), trigger point injections (5) and suture release (5). Compared to SSLF patients, SSLH patients were more likely to need interventions (7 [7.1%] vs. 5 [1.6%], p = 0.005) and office visits (14 [14.3%] vs. 13 [4.2%], p = 0.0005) for pain. CONCLUSIONS: There was no difference in the overall incidence of postoperative pain between patients who underwent SSLF or SSLH. However, patients who underwent hysteropexy were more likely to need intervention and office evaluation for postoperative pain.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

A randomized double-blind placebo-controlled trial on the effect of local analgesia on postoperative gluteal pain in patients undergoing sacrospinous ligament colpopexy.

BACKGROUND: The incidence of temporary gluteal pain after sacrospinous ligament colpopexy ranges from 6.1% to 15.3%. Gluteal pain may occur as a result of injury to S3 to S5 nerve roots that course over the mid-portion of the coccygeus-sacrospinous ligament complex at the time of suspension suture placement. There are no data on the use of injections to prevent postoperative pain from nerve entrapment at the time of suture placement. OBJECTIVE: The purpose of this study was to determine whether intraoperative local analgesia that is administered at the level of the sacrospinous ligament can lessen the gluteal pain felt by patients postoperatively after sacrospinous ligament colpopexy. STUDY DESIGN: In a randomized double-blind placebo-controlled trial, women with vaginal apex prolapse who were undergoing surgical treatment with sacrospinous ligament colpopexy underwent intraoperative injection with either 0.25% bupivacaine or normal saline solution. Subjects completed visual analog pain scales (0-10) and the Activities Assessment Scale and recorded the use of pain medications over a 6-week period. The primary outcome was postoperative gluteal pain. A sample size of 50 subjects (25 in each arm) was planned to test the hypothesis that local analgesia administration will lessen postoperative pain compared with placebo. RESULTS: Between April 2014 and March 2016, 51 women were enrolled in the study, and 46 women underwent sacrospinous ligament colpopexy. On postoperative day 1, 90.2% of all subjects (n=41) reported gluteal pain. At weeks 1 and 2, 63.8% (n=29) and 44.1% (n=20) women reported pain; at weeks 4 and 6, 33.3% (n=15) and 26.9% (n=12) women continued to have some pain. On day 1, the mean score for gluteal pain was 3.7±2.9. By week 1, the score was 1.8±2.6; by week 6, the mean score was 0.1±0.3. There were no differences in pain scores for patients who had undergone injection with 0.25% bupivacaine and those who were injected with normal saline solution. Patients in the placebo group used significantly more nonsteroidal antiinflammatory drugs than the treatment group: adjusted odds ratio, 1.25; 95% confidence interval, 1.04-1.35; P=.01). By 6 weeks, 87.5% of patients had returned to their baseline "light" activity level. There was no difference in time to return to baseline between the groups. CONCLUSION: Intraoperative administration of local analgesia does not reduce patients' perceptions of postoperative gluteal pain after sacrospinous ligament colpopexy; however, it may reduce the need for pain medication after surgery.