Cost-Utility Analysis of Midurethral Sling Timing Among Women Undergoing Prolapse Surgery.

IMPORTANCE: There are no guidelines regarding the ideal timing of midurethral sling (MUS) placement following prolapse repair. OBJECTIVE: The objective of this study was to estimate the cost-utility of concomitant MUS versus staged MUS among women undergoing apical suspension surgery for pelvic organ prolapse. STUDY DESIGN: Cost-utility modeling using a decision analysis tree compared concomitant MUS with staged MUS over a 1-year time horizon. The primary outcome was the incremental cost-effectiveness ratio (ICER). Six scenarios were modeled to estimate cost-utilities for women with preoperative overt, occult, or no stress urinary incontinence (SUI) who underwent either minimally invasive sacrocolpopexy or vaginal native tissue apical suspension. Possible complications of de novo overactive bladder, urinary retention requiring sling lysis, mesh exposure, and persistent SUI were included. Costs from a third-party payer perspective were derived from Medicare 2022 reimbursements. One-way sensitivity analyses were performed. RESULTS: Among women without preoperative SUI, staged MUS was the dominant strategy for both surgical routes with higher utility and lower costs. For women with either occult or overt SUI undergoing sacrocolpopexy or vaginal repair, concomitant MUS was cost-effective (ICER = $21,114-$96,536 per quality-adjusted life-year). Therefore, concomitant MUS is preferred for patients with preoperative SUI as higher costs were offset by higher effectiveness. One-way sensitivity analyses demonstrated that ICERs were most affected by probability of cure following MUS. CONCLUSIONS: A staged MUS procedure is the dominant strategy for women undergoing apical prolapse repair without preoperative SUI. In women with either overt or occult SUI, the ICER was below the willingness-to-pay threshold of $100,000 per quality-adjusted life-year, suggesting that concomitant MUS surgery is cost-effective.

Comparing Minimally Invasive Sacrocolpopexy With Vaginal Uterosacral Ligament Suspension: A Multicenter Retrospective Cohort Study Through the Fellows' Pelvic Research Network.

IMPORTANCE: Comparing one-year surgical outcomes of two widely used surgical procedures for apical suspension. OBJECTIVES: The objective of this study is to compare anatomic outcomes after minimally invasive sacrocolpopexy (MISC) and vaginal uterosacral ligament suspension (vUSLS). STUDY DESIGN: This was a multicenter, retrospective cohort study through the Fellows' Pelvic Research Network. Patients with ≥ stage II pelvic organ prolapse (POP) who underwent MISC or vUSLS from January 2013 to January 2016, identified through the Current Procedural Terminology codes, with 1 year or longer postoperative data were included. Patients with prior POP surgery or history of connective tissue disorders were excluded. Anatomic success was defined as Pelvic Organ Prolapse Quantification System measurements: Ba/Bp ≤ 0 or C ≤ -TVL/2. Data were compared using χ 2 or Fisher exact tests. Continuous data were compared using Wilcoxon rank sum test. RESULTS: Three hundred thirty-seven patients underwent MISC (171 laparoscopic, 166 robotic) and 165 underwent vUSLS. The MISC group had longer operative time (205.9 minutes vs 187.5 minutes, P = 0.006) and lower blood loss (77.8 mL vs 187.4 mL; P < 0.001). Two patients (0.6%) in the MISC group had mesh exposure requiring surgical excision. Permanent suture exposure was higher after vUSLS (6.1%). At 1 year, anatomic success was comparable in the apical (322 [97%] MISC vs 160 [97%] vUSLS, P = 0.99) and posterior compartments (326 [97.6%] MISC vs 164 [99.4%] vUSLS; P = 0.28). Anterior compartment success was higher in the MISC group (328 [97.9%] vs 156 [94.9%], P = 0.04) along with longer total vaginal length (9.2 ± 1.8 vs 8.4 ± 1.5, P < 0.001). CONCLUSION: At 1 year, patients who underwent MISC or vUSLS had similar apical support. Low rates of mesh and suture exposures, less anterior recurrence, and longer TVL were noted after MISC.

Total Vaginal Hysterectomy With Uterosacral Ligament Suspension Compared With Supracervical Hysterectomy With Sacrocervicopexy for Uterovaginal Prolapse.

OBJECTIVE: To compare prolapse recurrence after total vaginal hysterectomy with uterosacral ligament suspension to recurrence after supracervical hysterectomy with mesh sacrocervicopexy for the primary management of uterovaginal prolapse. METHODS: We conducted a retrospective cohort study of women undergoing uterovaginal prolapse repair at an academic center from 2009 to 2019. Women who underwent vaginal hysterectomy with uterosacral ligament suspension or laparoscopic supracervical hysterectomy with mesh sacrocervicopexy were included. The primary outcome was composite prolapse recurrence (prolapse beyond the hymen or retreatment with pessary or surgery). Secondary outcomes included mesh complications, time to recurrence, and overall reoperation for either prolapse recurrence or mesh complication. We used propensity scoring with a 2:1 ratio of sacrocervicopexy to uterosacral suspension. RESULTS: The cohort consisted of 654 patients, of whom 228 (34.9%) underwent uterosacral suspension and 426 (65.1%) underwent sacrocervicopexy. The median follow-up was longer for the sacrocervicopexy group (230 vs 126 days, P<.001) and less than 1 year for both groups. The uterosacral group had a greater proportion of composite prolapse recurrence (14.9% [34/228] vs 8.7% [37/426], P=.02) and retreatment for recurrent prolapse (7.5% [17/228] vs 2.8% [12/426], P=.02). The uterosacral group demonstrated a shorter time to prolapse recurrence on multivariable Cox regression (hazard ratio 3.14, 95% CI 1.90-5.16). There were 14 (3.3%) mesh complications in the sacrocervicopexy group. Overall reoperation was similar between groups (4.8% [11/228] vs 3.8% [16/426], P=.51). CONCLUSION: Total vaginal hysterectomy with uterosacral ligament suspension was associated with higher rate of, and shorter time-to-prolapse recurrence compared with supracervical hysterectomy with mesh sacrocervicopexy.

Antibiotic Prophylaxis During Catheter-Managed Postoperative Urinary Retention After Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate whether nitrofurantoin prophylaxis decreases the incidence of culture-documented urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery. METHODS: This double-blind, placebo-controlled, randomized trial was conducted at five academic institutions. Women with urinary retention after surgery for prolapse or incontinence were randomized to oral nitrofurantoin 100 mg daily during indwelling or clean intermittent self-catheterization. The primary outcome was the incidence of symptomatic urinary tract infection within 6 weeks of surgery, confirmed by culture demonstrating more than 1,000 colony forming units per milliliter of uropathogenic bacteria. Secondary outcomes were adverse symptoms possibly attributable to nitrofurantoin and bacterial resistance to nitrofurantoin. A sample size of 154 would detect a decrease in urinary tract infection incidence from 33% to 13%, with 80% power, two-sided alpha of 0.05, and allow 10% dropout. RESULTS: Of 154 participants randomized from September 2016 to May 2018, 151 were eligible for analysis: 75 received nitrofurantoin, and 76 received placebo. Demographics were similar between groups. The indication for surgery was prolapse (46%), incontinence (20%), or a combination (34%). Participants were discharged with an indwelling catheter (58%) or performing self-catheterization (42%). Median duration of catheter use was 4 days (interquartile range 3-7). Thirteen women in the nitrofurantoin group and 13 women in the placebo group experienced urinary tract infection (17.3% vs 17.1%, P=.97, relative risk [RR] [95% CI] 1.01 [0.50-2.04]). Adverse symptoms possibly attributable to nitrofurantoin were common in both groups (68% vs 61%, P=.34, RR [95% CI] 1.12 [0.88-1.43]). Resistance to nitrofurantoin was identified in seven urine cultures, four among nitrofurantoin and three among placebo recipients. In total, 52 urine cultures were obtained to evaluate symptoms of urinary tract infection, and only 27 of 52 grew at least 1,000 cfu/mL of uropathogenic bacteria. CONCLUSION: Daily nitrofurantoin did not reduce the incidence of culture-proven urinary tract infection among women with catheter-managed urinary retention after pelvic reconstructive surgery. Culture confirmed urinary tract infection in only half of symptomatic episodes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02727322.

Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures.

OBJECTIVE: The aim of the study was to evaluate postoperative genital hiatus after apical suspension procedures without a level 3 support procedure (L3SP), posterior repair, and perineorrhaphy, compared with normative-value genital hiatus of 3.4 cm. METHODS: This an analysis of a pre-existing retrospectively collected database that included all minimally invasive sacrocolpopexies and uterosacral ligament suspensions performed at a tertiary medical center from January 2009 to August 2015. RESULTS: We identified 1006 surgical cases: 160 (15.9%) apical suspensions with L3SPs and 846 (84.1%) without. Mean (SD) age was 59 (9) years and body mass index was 27.6 (4.7) kg/m. Women were mainly white (97.4%) with stage III prolapse (67.8%). Those who underwent L3SPs were more likely to be premenopausal and undergo hysterectomy and USLS.Baseline genital hiatus was similar with and without L3SPs (4.8 [1.2] cm vs 4.6 [1.1] cm, P = 0.096). Postoperative genital hiatus was reduced beyond normative (3.4 cm) after apical suspension without (3.0 [0.7] cm, P < 0.001) and with (2.8 [0.9] cm, P < 0.001) L3SPs. Postoperative genital hiatus after L3SPs was similar to those without (2.8 [0.9] cm vs 3.0 [0.7] cm, P = 0.06). We found that change in genital hiatus was greater, by 0.7 cm, when L3SP was performed versus not performed (2.3 [1.2] cm vs 1.6 [1.1] cm, P < 0.001). CONCLUSIONS: Level 3 support procedures may be unnecessary to restore genital hiatus to normal at time of apical suspension procedures and should be reserved for select patients.

Prolapse recurrence following sacrocolpopexy vs uterosacral ligament suspension: a comparison stratified by Pelvic Organ Prolapse Quantification stage.

BACKGROUND: Insufficient evidence evaluates which pelvic organ prolapse surgery is best suited to an individual woman based on the stage of her prolapse. OBJECTIVE: We sought to compare prolapse recurrence rates following sacrocolpopexy and uterosacral ligament suspension after stratifying by preoperative Pelvic Organ Prolapse Quantification stage. STUDY DESIGN: We compared all women who underwent minimally invasive sacrocolpopexy or vaginal or minimally invasive uterosacral ligament suspension from 2009 through 2015 at a large academic center. All women with preoperative and postoperative Pelvic Organ Prolapse Quantification data were included. Patients were grouped by preoperative Pelvic Organ Prolapse Quantification stage for analysis. Recurrence rates following sacrocolpopexy and uterosacral ligament suspension were compared for patients presenting with stage II, III, and IV prolapse, adjusting for potential confounders in regression models. Prolapse recurrence was defined as any retreatment for prolapse or any Pelvic Organ Prolapse Quantification point beyond the hymen. RESULTS: Of 756 women, 633 underwent sacrocolpopexy (83.7%) and 123 (16.3%) underwent uterosacral ligament suspension. In all, 189 (25%) had preoperative Pelvic Organ Prolapse Quantification stage II prolapse, 527 (69.7%) stage III, and 40 (5.3%) stage IV. Patients were predominantly Caucasian (97.3%) with mean age 59.8 ± 9.5 years. Compared to uterosacral ligament suspension patients, more sacrocolpopexy patients had undergone prior prolapse repair (20.9% vs 5.7%, P < .001) and fewer had known diabetes mellitus (7.9% vs 13.8%, P = .034). Characteristics of the groups were otherwise similar. Median follow-up was 41.0 (interquartile range 13.0-88.8) weeks. Stage II prolapse patients had similar recurrence rates following sacrocolpopexy or uterosacral ligament suspension (6.0% vs 5.0, P = 1.00). However, stage III prolapse patients were more likely to experience recurrence following uterosacral ligament suspension (25.7% vs 7.8%, P < .001). This difference persisted after controlling for age, body mass index, smoking, diabetes, and prior prolapse repair (odds ratio, 4.3; 95% confidence interval, 2.2-8.2). There was no discernable difference in recurrence rates for women with stage IV prolapse, although sample size was limited. CONCLUSION: Sacrocolpopexy resulted in a lower prolapse recurrence rate than uterosacral ligament suspension for stage III prolapse. However, there was no difference in recurrence rate among women with preoperative stage II prolapse, suggesting mesh augmentation may not be indicated for these patients. Larger prospective trials are necessary for confirmation.

Clinical Utility of Hemoglobin Testing After Minimally Invasive Sacrocolpopexy.

OBJECTIVE: To determine the clinical utility of routine postoperative hemoglobin screening after minimally invasive sacrocolpopexy. METHODS: This is a retrospective chart review of women undergoing minimally invasive sacrocolpopexy between 2009 and 2015 at a large academic center where postoperative hemoglobin assessment is performed as routine practice. Demographic and perioperative data, pre- and postoperative hemoglobin values, and clinical signs and symptoms of potential postoperative anemia were extracted. Hemoglobin parameters were compared between women with and without clinical evidence of potential postoperative anemia. Linear and logistic regression analyses were used to identify predictors of postoperative anemia and magnitude of hemoglobin decrease. RESULTS: Among 800 women, postoperative hemoglobin was obtained for 99.6% and prompted further testing among 23.8%. Mean postoperative hemoglobin was 11.78 ± 1.11 g/dL, and mean decrease was 1.76 ± 0.95 g/dL. More than half (56.9%) had clinical evidence of potential anemia, but few (5%) had postoperative hemoglobin of 10 g/dL or less and none required transfusion. Women with clinical evidence of potential anemia had lower postoperative hemoglobin (11.57 vs 12.19; P < 0.001) and larger mean hemoglobin decrease (1.91 vs 1.49; P < 0.001). On regression analyses, only lower body mass index was associated with larger hemoglobin decrease (ß = -0.030, P < 0.001) and no factor significantly predicted postoperative hemoglobin of 10 g/dL or less. CONCLUSIONS: Routine hemoglobin testing rarely benefited clinical care but lead to further testing for nearly 1 in 4 patients. Although many women demonstrated clinical evidence potentially suggestive of anemia, significant anemia was rare and no women required transfusion. Neither estimated blood loss nor other risk factors consistently predicted presence of postoperative anemia or significant postoperative decrease in hemoglobin.

Evaluating the Impact of Intraoperative Surgical Team Handoffs on Patient Outcomes.

OBJECTIVE: The aim of the study was to assess the impact of intraoperative personnel handoffs on clinical outcomes in patients undergoing minimally invasive sacrocolpopexy (SCP). METHODS: We retrospectively reviewed SCPs performed at an academic center between 2009 and 2014. We analyzed the number of staff handoffs, defined as any instance a scrub technician (tech) or circulating nurse handed off responsibility for a break or shift change. Outcomes included operative (OR) time and composite variables for major complications (conversion to an open procedure, bladder injury, bowel injury, blood transfusion, infection, ileus, bowel obstruction, readmission, or mesh complication) and prolapse recurrence (prolapse at or beyond the hymen or retreatment). Postoperative complications were defined as being within 6 weeks of surgery. Mesh complications and prolapse recurrence were recorded for the entire 68-month study period. RESULTS: Of 814 patients, 97.4% were white, 85.3% postmenopausal, mean (SD) age 59.7 (8.8) years, and mean (SD) body mass index 27.5 (4.5) kg/m. Most had stage 3 prolapse (n = 563, 69.9%). There were 478 (58.7%) laparoscopic and 336 (41.3%) robotic SCPs. The median scrub tech and nurse handoff per case was 1.0 (interquartile range [IQR], 0.0-1.0) and 1.0 (IQR, 1.0-2.0), respectively. Mean (SD) OR time was 204.8 (69.0) minutes. One hundred twenty-nine patients (15.8%) had a major complication and 45 (7.5%) experienced prolapse recurrence over a median follow-up interval of 41.0 weeks (IQR, 12.0-101.0). On multivariable linear regression, each tech and nurse handoff was associated with an increased OR time of 13.6 (P < 0.001) and 9.4 minutes (P < 0.001), respectively. Thus, the median of 1 tech and 1 nurse handoff per case will increase OR time by 23.0 minutes (11.2%). On multivariable logistic regression, staff handoffs were not associated with major complications or prolapse recurrence. CONCLUSIONS: Intraoperative scrub technician and circulating nurse handoffs increased OR time for minimally invasive SCP procedures.

Impact of Case Order on Laparoscopic Sacrocolpopexy: Do Surgeons Need a Warm-Up?

OBJECTIVES: Warm-up is defined as a preparatory activity or procedure. Using case order as a surrogate for surgeon warm-up, first cases were compared with second or later cases for intraoperative complications, operative time, and length of stay (LOS) among women undergoing laparoscopic sacrocolpopexy. METHODS: This is a retrospective study of laparoscopic sacrocolpopexies performed from 2009 through 2014 at a large academic center. Any surgery preceding laparoscopic sacrocolpopexy was considered a surrogate for surgeon warm-up. Logistic and linear regression analyses were used to identify predictors of complications, operative time, and LOS. RESULTS: Of 480 procedures, 192 (40%) were first cases and 288 (60%) were second or later. Baseline characteristics were similar between groups. Intraoperative complication rate was not different between groups (6.3% vs 3.1%, P = 0.50) even after controlling for risk factors. Operative times were comparable on initial analysis (231.2 ± 55.2 vs 225.9 ± 51.2 minutes, P = 0.28l), but a small difference was detected after adjusting for confounding factors (body mass index, menopausal status, surgeon experience, intraoperative complications, and concomitant hysterectomy or midurethral sling; adjusted ß = 8.44 minutes, P = 0.037). Length of stay was longer for first case patients (1.44 ± 0.67 vs 1.24 ± 0.50 days, P < 0.001) even after adjusting for age, medical comorbidities, operative time, conversion to laparotomy, ileus/bowel obstruction, and postoperative urinary retention (adjusted ß = 0.183 days, P = 0.001) as well as after accounting for delayed start time of second or later cases. CONCLUSIONS: Laparoscopic sacrocolpopexy performed first case of the day without preoperative surgeon warm-up conferred no significant increase in intraoperative complications. Second or later cases were associated with small decreases in operative time and in LOS.

The Impact of Obesity on Intraoperative Complications and Prolapse Recurrence After Minimally Invasive Sacrocolpopexy.

OBJECTIVE: Our objective was to compare the risk of intraoperative complications and prolapse recurrence among normal-weight, overweight, and obese women after minimally invasive sacrocolpopexy. METHODS: This is a retrospective study of all laparoscopic and robotic sacrocolpopexies performed at a large academic center from 2009 to 2014. Patient demographics and clinical and surgical data were compared between normal-weight, overweight, and obese women using χ test, analysis of variance (ANOVA), and logistic regression. RESULTS: Of the 556 subjects, 187 (33.6%) were normal weight, 248 (44.6%) were overweight, and 121 (21.8%) were obese. Compared with normal-weight and overweight women, obese women had more medical comorbidities (56.2% vs 29.4% and 39.5%, P < 0.001) and were more likely to undergo robotic surgery (odds ratio, 1.40; 95% confidence interval, 1.01-1.94). Obese women experienced greater blood loss compared with overweight women (82.4 [76.1] vs 63.8 [51.6] mL, P = 0.03) and longer operative times compared with both normal-weight and overweight women (250.7 [57.0] vs 233.8 [58.2] minutes, P = 0.04, and 250.7 [57.0] vs 233.8 [57.2] minutes, P = 0.03). Obesity was a significant predictor of intraoperative complications even after correcting for surgeon experience, estimated blood loss, and concomitant hysterectomy (adjusted odds ratio, 3.42; 95% confidence interval, 1.21-9.70). Few women (7.6%) experienced recurrence of prolapse. Obesity was not a significant predictor of prolapse recurrence. CONCLUSIONS: In women undergoing minimally invasive sacrocolpopexy, obesity is associated with increased blood loss, longer operative times, and more intraoperative complications, specifically conversions to laparotomy. Even after correcting for blood loss, surgeon experience, and concomitant hysterectomy, obese women were 3 times as likely to have an intraoperative complication. Our data did not show that obesity was associated with increased risk of prolapse recurrence; however, postoperative follow-up was limited.

Stress Urinary Incontinence: Comparative Efficacy Trials.

Women seeking relief from symptoms of stress urinary incontinence (SUI) may choose from a broad array of treatment options. Therapies range from lifestyle/behavioral modification to surgical interventions, and differ in terms of both effectiveness and risk. Individualized treatment plans can be developed to address a patient's expectations and goals for treatment, as well as her tolerance for potential adverse events. This article reviews the highest-quality clinical trials comparing contemporary treatment options for women with SUI. Clinicians and patients can use this compendium to inform their treatment selection.

Comparison of complications and prolapse recurrence between laparoscopic and vaginal uterosacral ligament suspension for the treatment of vaginal prolapse.

INTRODUCTION AND HYPOTHESIS: Our objective was to compare complications and prolapse recurrence between laparoscopic (L-USLS) and vaginal (V-USLS) uterosacral ligament suspensions. METHODS: This is a retrospective study of USLS procedures performed at a large academic center from 2011 to 2014. Patient demographics, surgical data, complications, and prolapse recurrence of L-USLS and V-USLS were compared. Logistic regression identified predictors of operative time, complications, and prolapse recurrence. RESULTS: There were 54 L-USLS and 119 V-USLS procedures with median follow-up of 21.5 weeks (IQR 9.3-50.8). Women undergoing L-USLS were less likely to have medical comorbidities and had less severe prolapse, but were more likely to report prior hysterectomy. L-USLS had longer operative times (190.1 ± 46.8 vs 172.7 ± 47.3 min, p = 0.03), but after correcting for concomitant procedures, the operative times of the two approaches were not significantly different (adjusted OR 1.00, 95%CI 0.99-1.00). There was no significant difference in complications between groups (24.1 % vs 21.8 %, p = 0.75). However, there were nonsignificant trends toward more ureteral injuries and suture removals following V-USLS. Postoperative POP-Q points of the groups did not differ, except for total vaginal length (TVL), which was longer after L-USLS (8.3 ± 1.1 cm vs 7.4 ± 1.2 cm, p < 0.001). 19 patients met the composite definition of prolapse recurrence, with no significant difference between groups (16.2 % vs 16 %, p = 0.98). After adjusting for preoperative prolapse stage, route was not a significant predictor of prolapse recurrence (adjusted OR 0.39, 95 % CI 0.12-1.30). CONCLUSIONS: L-USLS has comparable clinical outcomes, with similar rates of complications and prolapse recurrence to the traditional vaginal approach.