Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Sacrospinous Fixation and Vaginal Uterosacral Suspension-Evaluation in Uterine Preservation Surgery.

IMPORTANCE: Vaginal hysteropexy can be performed via the uterosacral or the sacrospinous ligament(s), but little data exist comparing these routes. OBJECTIVE: The aim of the study was to compare prolapse recurrence, retreatment, and symptoms along with the incidence of adverse events between patients undergoing vaginal uterosacral hysteropexy and sacrospinous hysteropexy. STUDY DESIGN: This was a multicenter retrospective cohort study of patients who underwent vaginal uterosacral or sacrospinous hysteropexy (SSHP) between 2015 and 2019. Anatomic failure was the primary outcome, defined as prolapse beyond the hymen. Composite failure was defined as anatomic failure, bulge symptoms, and/or retreatment for prolapse. RESULTS: At 4 geographically diverse referral centers, 147 patients underwent SSHP and 114 underwent uterosacral hysteropexy. The 1-year follow-up rate was 32% (83/261) with no difference between groups. There were 10 (3.8%) anatomic failures: 3 (2%) sacrospinous and 7 (6.1%) uterosacral ( P = 0.109). There was no difference in bulge symptoms (9.9%), composite failure (13%), or median prolapse stage (2).The overall incidence of complications was low (7%; 95% confidence interval, 4.12%-10.43%) with a higher rate of ureteral kinking in the uterosacral group (7% vs 1.4%, P = 0.023). With a median follow-up of 17 months, 4.6% underwent subsequent hysterectomy and 6.5% had treatment for uterine/cervical pathology. CONCLUSIONS: One year after hysteropexy, 1 in 3 patients were available for follow-up, and there were no differences in prolapse recurrence between patients who underwent uterosacral hysteropexy versus SSHP. The incidence of adverse events was low, and less than 5% of patients underwent subsequent hysterectomy for prolapse.

Characterization of Pain Associated With Pelvic Organ Prolapse: Is Surgery the Answer?

IMPORTANCE: Data on the incidence of pelvic organ prolapse (POP)-related pain, risk factors for its development, and treatment effects of surgery remain sparse. OBJECTIVES: The aims of the study were to evaluate the incidence and characteristics of POP-related pain in patients presenting with POP and assess the outcome of pain after surgery. STUDY DESIGN: This was a retrospective study of patients presenting for initial evaluation of POP from May 2019 to May 2020. Using a standardized questionnaire, patients were asked "Do you have pain associated with your prolapse (not pressure or fullness)?" and to indicate pain severity and location(s). Patients who underwent surgery were asked postoperatively if their POP-related pain resolved. Patient and perioperative characteristics were obtained from the medical record and used to evaluate relationships between the presence and resolution of POP-related pain. RESULTS: Of the 795 patients who met inclusion criteria, 106 (13.3%) reported POP-related pain. The mean age of all patients was 59.9 years, 38.1% had stage 3 or greater POP, and 52.1% were sexually active. Women with POP-related pain reported a median severity of 5 of 10. The most common pain locations were the vagina (46.6%), lower abdomen (27.4%), and back (9.6%). Fifty-seven women with pain (53.8%) underwent surgery, and 40 (70.2%) reported postoperative pain resolution. Of those who did not have resolution, pain improved or remained stable in severity. No patients reported worsening pain after surgery. CONCLUSIONS: Pain is a symptom experienced by more than 1 in 8 women presenting with POP, with 70% reporting resolution of their pain postoperatively.

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.

Perioperative Adverse Events in Women Undergoing Vaginal Prolapse Repair With Uterine Preservation Versus Concurrent Hysterectomy: A Matched Cohort Study.

OBJECTIVE: The objective of this study is to compare the incidence of perioperative adverse events (AEs) in women undergoing vaginal prolapse repair with uterine preservation (hysteropexy) versus concurrent hysterectomy. METHODS: This was a retrospective matched cohort study between 2012 and 2019. Patients who received a sacrospinous or uterosacral hysteropexy or colpopexy with hysterectomy were matched by surgeon, surgical year, and age. The electronic medical record was queried for demographic and perioperative data. Strict definitions were used for all clinically relevant AEs. RESULTS: One hundred and thirty hysteropexy (89 sacrospinous, 41 uterosacral) patients were matched to 260 concurrent hysterectomy (6 sacrospinous, 253 uterosacral, 1 both) patients. Mean age and body mass index were 58 years (±13 years) and 27.9 kg/m2 (±6 kg/m2). Compared with hysteropexy, cases with hysterectomy were longer, had higher blood loss, and a longer hospital stay. The overall incidence of AEs was 29.0% for concurrent hysterectomy versus 10.5% in hysteropexy cases (P = 0.02); on logistic regression, concurrent hysterectomy remained a statistically significant predictor of AEs, with an adjusted odds ratio of 4.03 (95% confidence interval, 1.48-11.01). There was no difference in Dindo grade 3 complications between concurrent hysterectomy and hysteropexy procedures (0.8% vs 1.3%, P = 0.12). In a subanalysis examining the 2 hysteropexy types, there were no significant differences in AEs. CONCLUSIONS: The overall incidence of serious AEs is low in women with uterovaginal prolapse undergoing vaginal native tissue repair with or without hysterectomy. Vaginal hysteropexy is associated with lower odds of experiencing AEs, shorter operating times, a shorter length of stay, and less blood loss.

Neurologic Injury After Sacral Neuromodulation.

OBJECTIVE: Neurologic injury after sacral nerve stimulation (SNS) is rare, but the incidence is unknown. Infection is a potential mechanism for neurologic damage. This report illustrates the presentation, pathophysiology, diagnostic considerations, and treatment of epidural infection causing neurologic deficits after SNS. CASE REPORT: We present a case of a woman with severe fecal incontinence due to Crohn's disease who underwent SNS implantation and subsequently developed a wound infection requiring complete device explantation. A few days later, she presented with leg pain and weakness. Urgent evaluation and treatment of epidural infection were performed. She had persistent neurologic deficits 6 months later. CONCLUSIONS: Neurologic sequelae from an infection after SNS are a rare event and should be considered in patients with fevers, leg pain, and neurologic deficits.