Antibiotic utilization and symptom improvement in a retrospective cohort of women with urinary tract infection symptoms.

INTRODUCTION AND HYPOTHESIS: Urinary tract infections (UTIs) are one of the most common bacterial infections in women. We hypothesized that over half of those treated empirically would receive inappropriate antibiotics, those treated expectantly would have lower symptom improvement without antibiotics, and that overall progression to sequelae would be uncommon. METHODS: In this retrospective cohort study of women with UTI symptoms, we quantified the proportion who received inappropriate antibiotics in those treated empirically, defined as those with a negative urine culture or antibiotics that were changed according to culture sensitivities, and identified factors associated with symptom improvement during expectant management. Secondarily, we sought to determine the proportion of UTI sequelae in both groups. During the study time frame, a modified UTI Symptom Assessment (UTISA) questionnaire was administered at baseline and again, with a global rating for change instrument, when urine culture results were relayed. RESULTS: Analyses included 152 women, mean age 66.5 (SD 15.0) years, 30 (20%) received empiric antibiotics, and 122 (80%) expectant management. At baseline, the empiric group reported greater mean scores for dysuria (p < 0.01), urgency (p < 0.01), frequency (p < 0.01), and incomplete emptying (p < 0.01). Positive culture results were reported for 16 (53%) in the empiric group and 72 (59%) in the expectant group. Inappropriate antibiotics were prescribed to 18 (60%) of the empiric group. A negative urine culture was associated with improvement in symptoms in the expectant group. No subjects experienced UTI sequelae within 30 days of initial evaluation. CONCLUSION: In our cohort of older women with UTI symptoms, deferring antibiotics until urine culture  resulted appeared to be safe and decreased the use of inappropriate antibiotics.

Frailty and Acute Postoperative Urinary Retention in Older Women Undergoing Pelvic Organ Prolapse Surgery.

IMPORTANCE: Acute postoperative urinary retention (POUR) is common after pelvic reconstructive surgery, occurring in 15-45% of women. There is a paucity of data on the relationship between frailty and POUR after prolapse surgery. OBJECTIVE: This study aimed to examine the association between frailty and POUR in older women who underwent pelvic organ prolapse surgery. STUDY DESIGN: This secondary analysis of a prospective study of postoperative delirium enrolled women 60 years and older undergoing prolapse surgery. The Fried Frailty Index was used to assess frailty before surgery. Acute POUR was defined as failure to pass a retrograde voiding trial at hospital discharge with postvoid residual volume of greater than 100 mL. RESULTS: Analyses included 165 women, with a mean ± SD age of 72.5 ± 6.1 years and a body mass index of 28.0 ± 4.4 kg/m2. There were 49 laparoscopic/robotic apical suspension procedures (29.7%), 60 vaginal obliterative procedures (36.4%), 47 vaginal apical suspension procedures (28.5%), and 9 isolated anterior and/or posterior colporrhaphies (5.5%), of which 9 had a concomitant incontinence procedure. Seventy-eight women (47.3%) experienced acute POUR. Thirty-one (18.8%) met the criteria for "not frail," 115 (88.5%) were "prefrail," and 19 (11.5%) were "frail." Neither frailty status nor score was associated with POUR. In an analysis of individual Fried Frailty Index components, self-reported unintentional weight loss was significantly associated with POUR (odds ratio, 4.6; 95% confidence interval, 1.23-17.15). This remained significant on multivariable logistic regression (adjusted odds ratio, 4.06; 95% confidence interval, 1.01-16.39). CONCLUSIONS: Frailty was not associated with POUR in older women undergoing prolapse surgery. The observed association between POUR and unintended weight loss before surgery warrants further investigation.

Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. RESULTS: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. CONCLUSIONS: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.

Postoperative delirium in older patients after undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: To determine the 7-day incidence and risk factors of postoperative delirium (POD) occurring after prolapse surgery in women aged ≥60 years. METHODS: A prospective study of women ≥60 years undergoing prolapse surgery at a large academic center. The primary outcome is positive Confusion Assessment Method delirium screen administered in person or by telephone at the time of hospital discharge and postoperative days 1, 3, 5, and 7. RESULTS: This analysis included 165 patients, mean ± SD age of 72.5 ± 6.1 years, with median (IQR) years of education of 13 (12-16), and baseline Modified Mini-Mental Status (3MS) Exam score of 95 (92-98). Prolapse repair type was vaginal for 70% (n=115) and laparoscopic for 30% (n=50) of patients; most under general anesthesia, 151 (92.1%). The incidence of positive delirium screen during the first week after surgery was 12.1% (n=20). Most of these participants screened positive on postoperative day 0, 8.4% (n=14). In univariate analyses, a positive screen was associated with older age and fewer education years, lower 3MS exam score, greater baseline geriatric depression scale score, and greater frailty score. Lower 3MS score was the only variable that remained significant in the final model (adjusted odds ratio 0.84, 95% CI 0.75-0.95). CONCLUSIONS: One in 12 women ≥60 years deemed eligible for discharge on the day of prolapse surgery screens positive for delirium. The 7-day POD incidence is comparable to other elective non-cardiac surgery cohorts. Given the increasing trend toward same day discharge after major prolapse surgery, more research is needed to determine the impact of universal delirium screening as part of discharge assessments.

Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

Anatomic Variation of Sacral Mesh Attachment During Minimally Invasive Sacrocolpopexy.

IMPORTANCE: Although anatomic level of mesh attachment to the sacrum varied during minimally invasive sacrocolpopexy with a large proportion above S1, this was not associated with pelvic organ prolapse recurrence. OBJECTIVE: This study aimed to describe the anatomic level of sacral mesh attachment and its association with prolapse recurrence after minimally invasive sacrocolpopexy. STUDY DESIGN: This study included a retrospective cohort of women who underwent minimally invasive sacrocolpopexy with subsequent abdominal and pelvic imaging (magnetic resonance imaging or computed tomography) between 2010 and 2019 at a single academic institution. Anatomic level of attachment was determined by a radiologist. Prolapse recurrence was defined as a composite of self-reported bulge symptoms, any prolapse measure beyond the hymen, and any retreatment with pessary or surgery. χ 2 Tests were used for comparative outcomes. RESULTS: Analyses included 212 women. The mean ± SD age was 58.8 ± 9.9 years, the majority have preoperative stage III/IV prolapse (81.1%), and the median follow-up was 269 days (interquartile range, 57-825 days). Mesh was attached using titanium tacks (n = 136 [64.2%]) and suture (n = 76 [35.8%]) at the level of the L5-S1 intervertebral space (n = 113 [53.3%]) or overlying S1 (n = 89 [42.0%]).The surgical approach was significantly associated with attachment location with a greater proportion of laparoscopy cases demonstrating mesh attachment above S1 (85 [62.5%] vs robotically, 30 [39.5%]; P < 0.01). Dichotomized level of attachment was not associated with composite prolapse recurrence (above S1, n = 18 [22.2%] vs below S1, n = 24 [24.7%]; P = 0.69) or any compartment recurrence ( P ≥ 0.36). CONCLUSIONS: Mesh was primarily attached to the anterior longitudinal ligament at the level of the L5-S1 intervertebral space or S1. Level of mesh attachment was not associated with composite prolapse recurrence.

Characteristics associated with composite surgical failure over 5 years of women in a randomized trial of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension.

BACKGROUND: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years. OBJECTIVE: This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse. STUDY DESIGN: This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors. RESULTS: In the final multivariable model, body mass index (increase of 5 kg/m2: adjusted hazard ratio, 1.7; 95% confidence interval, 1.3-2.2; P<.001) and duration of prolapse symptoms (increase of 1 year: adjusted hazard ratio, 1.1; 95% confidence interval, 1.0-1.1; P<.005) were associated with composite surgical failure, where rates of failure were 2.9 and 1.8 times higher in women with obesity and women who are overweight than women who have normal weight and women who are underweight (95% confidence intervals, 1.5-5.8 and 0.9-3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms than women experiencing ≤5 years prolapse symptoms (95% confidence interval, 1.8-5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with uterosacral suspension (adjusted hazard ratio, 0.6; 95% confidence interval, 0.4-1.0; P=.05). The interaction between symptom duration and apical repair (P=.07) indicated that failure was less likely after hysteropexy than hysterectomy for those with ≤5 years symptom duration (adjusted hazard ratio, 0.5; 95% confidence interval, 0.2-0.9), but not for those with >5 years symptom duration (adjusted hazard ratio, 1.0; 95% confidence interval 0.5-2.1). CONCLUSION: Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.

Preprocedure and Immediate Postoperative Changes to Genital Hiatus Following Minimally Invasive Sacrocolpopexy.

IMPORTANCE: This study assesses resting genital hiatus (GH) measurements under anesthesia as compared with in-office measurements for intraoperative planning purposes. OBJECTIVES: The aim of this study was to determine the influence of general anesthesia and apical suspension on GH measurements compared with office measurements. STUDY DESIGN: This was a retrospective cohort of women who underwent minimally invasive sacrocolpopexy within an academic urogynecology practice. Genital hiatus for each patient was measured at 4 time points: (1) preoperative office examination (baseline) at rest (GH rest ) and with strain (GH strain ); (2) following anesthesia induction, at rest (GH induction ); (3) immediately after sacrocolpopexy, at rest (GH colpopexy ); and (4) 4- to 6-week postoperative visit, strain (GH postop ). Enlarged baseline GH strain was defined as ≥4 cm. Paired statistics and analysis of variance were used for comparisons. RESULTS: Fifty-one women were included, whose mean age was 61.3 ± 8.2 years; the majority had stage ≥3 prolapse (n = 39 [76.4%]). Concomitant procedures included hysterectomy (n = 33 [64.7%]) and posterior colporrhaphy or perineorrhaphy (n = 8 [15.7%]). The majority had an enlarged baseline GH strain (n = 39 [76.4%]), and overall cohort mean was 4.7 ± 1.3 cm. Compared with baseline GH rest , mean GH induction was larger (GH induction : 4.6 ± 1.4 cm vs GH rest : 3.8 ± 1.2 cm, P < 0.01) but not different from baseline GH strain (GH induction : 4.6 ± 1.4 cm vs GH strain : 4.7 ± 1.3 cm, P = 0.81). GH colpopexy was decreased from baseline GH strain with a mean difference of 1.1 ± 1.3 cm ( P < 0.01). This difference was driven by women with enlarged baseline GH strain who experienced a mean decrease of 1.5 ± 1.1 cm ( P < 0.01). CONCLUSIONS: Genital hiatus after induction of anesthesia does not significantly differ from preoperative straining GH. Apical suspension with sacrocolpopexy alone resulted in immediate reduction in GH measures, with greater decreases observed in women with enlarged preoperative GH.

Long-term Urinary Outcomes After Transvaginal Uterovaginal Prolapse Repair With and Without Concomitant Midurethral Slings.

IMPORTANCE: Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement. OBJECTIVES: The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling. STUDY DESIGN: Secondary analysis of the Study of Uterine Prolapse Procedures Randomized Trial (hysterectomy with uterosacral ligament suspension vs mesh hysteropexy). Our primary outcome was Urinary Distress Inventory score (UDI-6) through 5 years compared between women with and without a concomitant sling within prolapse repair arms. Sling effect was adjusted for select clinical variables and interaction terms (α = .05). RESULTS: The sling group included 90 women (43 hysteropexy, 47 hysterectomy), and the no-sling group included 93 women (48 hysteropexy, 45 hysterectomy). At baseline, the sling group reported more bothersome stress (66% vs 36%, P < 0.001) and urgency incontinence (69% vs 48%, P = 0.007). For hysteropexy, there were no significant long-term differences in UDI-6 scores or bothersome urine leakage between sling groups. For hysterectomy, women with sling had better UDI-6 scores across time points (adjusted mean difference, -5.1; 95% confidence interval [CI], -9.9 to -0.2); bothersome stress and urgency leakage were less common in the sling group (stress adjusted odds ratio, 0.1 [95% CI, 0.0-0.4]; urge adjusted odds ratio, 0.5 [95% CI, 0.2-1.0]). Treatment for stress incontinence over 5 years was similar in the sling (7.9%) versus no-sling (7.6%) groups. CONCLUSIONS: Five-year urinary outcomes of concomitant midurethral sling may vary by type of transvaginal prolapse surgery, with possible benefit of midurethral sling at the time of vaginal hysterectomy with apical suspension but not after mesh hysteropexy.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

INTRODUCTION: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS: Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Subgroups of failure after surgery for pelvic organ prolapse and associations with quality of life outcomes: a longitudinal cluster analysis.

BACKGROUND: Treatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies. OBJECTIVE: This study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year. STUDY DESIGN: Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster. RESULTS: Surgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster. CONCLUSION: In particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

OBJECTIVES: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage. METHODS: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Incidence of Sacral Osteomyelitis and Discitis After Minimally Invasive Sacrocolpopexy.

OBJECTIVE: The incidence and associated risk factors for sacral osteomyelitis and sacral discitis after sacrocolpopexy remain unknown. The aim of this study was to determine the incidence of sacral osteomyelitis and discitis after minimally invasive sacrocolpopexy and their association with the method of sacral mesh fixation. METHODS: This is a retrospective cohort study of consecutive minimally invasive sacrocolpopexies performed by 11 female pelvic medicine and reconstructive surgery board-certified surgeons from January 2009 to August 2019 within a single health system. Sociodemographic, procedure, and clinical variables were abstracted from the electronic health record (EHR). We then performed a confirmatory EHR interrogation, cross-referencing procedural codes for laparoscopic and robot-assisted sacrocolpopexy and diagnostic codes for sacral osteomyelitis and sacral discitis. RESULTS: The EHR chart review identified 1,189 women who underwent laparoscopic (55.2%) and robot-assisted (44.8%) minimally invasive sacrocolpopexy, all with polypropylene mesh. Median follow-up was 7.7 months (interquartile range, 0-49.8). Titanium helical tacks were used in 52.7% patients, sutures in 41.6%, and both in 5.6%. No cases (0%) of sacral osteomyelitis or discitis were identified by chart review. The system-wide EHR interrogation of procedural and diagnostic codes identified 421 additional procedures for a total of 1,610 minimally invasive sacrocolpopexies. Among these, there were no cases (0%) of osteomyelitis or discitis. CONCLUSIONS: Sacral osteomyelitis and discitis are rare early outcomes after minimally invasive sacrocolpopexy with an incidence of less than 1/1,000 cases. Given an absence of cases, we were unable to assess for an association between method of sacral attachment and sacral osteomyelitis and sacral discitis.

Postoperative Opioid Utilization in Older Women Undergoing Pelvic Organ Prolapse Surgery.

OBJECTIVES: The objective of this study was to determine total postoperative opioid consumption by women 60 years and older during the first week after pelvic organ prolapse surgery. We secondarily aimed to describe opioid prescribing patterns in this cohort. METHODS: This is a secondary analysis of a prospective cohort study assessing changes in cognition in women 60 years and older undergoing prolapse surgery. Postoperative opioid use at home during the first week was collected through daily self-reported diary entries. Total postoperative opioid consumption was calculated by adding opioid administration in the postoperative anesthesia recovery unit, inpatient setting, and home opioid use (as documented in diary). Regression models were used to identify demographic and clinical factors associated with total postoperative opioid consumption in the top quartile of this cohort and home opioid use. RESULTS: Data from 80 women were analyzed. Mean ± SD age was 71.78 ± 6.14 years (range, 60-88 years). Fifty women (62.5%) underwent vaginal surgery, and 30 (7.5%) underwent laparoscopic/robotic surgery, with concomitant hysterectomy in 47 (58.8%). The median (interquartile range) total morphine milligram equivalents used during the first week after surgery was 30 (7.5-65.75). The median (interquartile range) total morphine milligram equivalents prescribed was 225 (150-225). CONCLUSIONS: Opioid consumption after prolapse surgery in older women is very modest and equates to a median (interquartile range) of 4 (1-9) oxycodone (5 mg) tablets. Opioid prescribing patterns should be adjusted accordingly.

Assessing the Performance of the De Novo Postoperative Stress Urinary Incontinence Calculator.

OBJECTIVE: The aim of the study was to determine the performance of a previously published stress urinary incontinence (SUI) risk calculator in women undergoing minimally invasive or transvaginal apical suspensions. METHODS: Using a database of stress-continent women who underwent minimally invasive or transvaginal apical suspensions, we calculated 2 prediction risks for development of SUI within 12 months based on inclusion of a "prophylactic" midurethral sling at the time of prolapse surgery. Observed subjective and objective continence status was abstracted from medical records. Regression models were created for the outcome of de novo SUI to generate receiver operating curves. Concordance (c) indices were estimated for the overall and procedure subgroups to determine the calculator's ability to discriminate between SUI outcomes. RESULTS: Analyses included 502 women. De novo SUI was observed in 23.5% of women. The mean ± SD calculated risk of de novo SUI if a sling was performed was 18.9% ± 13.9 at 12 months compared with 36.4% ± 8.3 without sling. The calculator's discriminative ability for those with a planned sling was moderate (c-index = 0.55, P = 0.037). The calculator failed to discriminate continence outcomes when a sling was not planned in the overall group (c-index = 0.50, P = 0.799) and individual apical procedures. CONCLUSIONS: The SUI risk calculator is significantly limited in its ability to predict de novo SUI in our population of women planning minimally invasive apical suspensions. Refinements to the calculator model are needed to improve its utility in clinical practice.

Age and Perioperative Outcomes After Implementation of an Enhanced Recovery After Surgery Pathway in Women Undergoing Major Prolapse Repair Surgery.

OBJECTIVE: As perioperative care pathways are developed to improve recovery, there is a need to explore the impact of age. The aim of this study was to compare the impact of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway on perioperative outcomes across 3 age categories: young, middle age, and elderly. METHODS: A retrospective cohort study was conducted assessing same-day discharge, opioid administration, pain scores, and complications differences across and within 3 age categories, young (<61 years), middle age (61-75 years), elderly (>75 years), before and after ERAS implementation. RESULTS: Among 98 (25.7%) young, 202 (52.9%) middle-aged, and 82 (21.5%) elderly women, distribution before and after ERAS implementation was similar. In each age category, we found a commensurate increase in same-day discharge and decrease in length of stay independent of age. Age was associated with a variable response to opioid administration after ERAS. In women who received opioids, we found there was a greater reduction in opioids in elderly. Young women received 22.5 mg more than middle-aged women, whereas elderly women received 24.3 mg less than middle-aged women (P < 0.0001, P < 0.0001) for a mean difference of 46.8 mg between the youngest and oldest group. We found no significant differences in postanesthesia care unit pain scores with ERAS implementation. Complications did not increase after ERAS implementation in any age group, although younger and elderly women were more likely to experience complications independent of ERAS. CONCLUSIONS: Elderly women had similar outcomes compared with their younger counterparts after implementation of an ERAS pathway. Further research is needed to assess whether our age-related observations are generalizable.

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Incidence of postoperative cognitive dysfunction in older women undergoing pelvic organ prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Postoperative cognitive dysfunction (POCD), a transient impairment of memory, concentration, and information processing, has been reported after 7-26% of non-cardiac surgeries with associated increase in morbidity and death. Our primary aim was to determine the incidence of POCD 2 weeks after prolapse surgery in women ≥ 60 years old. Our secondary aim was to identify risk factors for POCD. METHODS: Prospective cohort study of women ≥ 60 years old scheduled for pelvic organ prolapse surgery. Exclusion criteria included cognitive impairment history, major neurologic disorder, and abnormal cognition screen. A comprehensive neuropsychologic (NP) battery (eight tests), administered 2 weeks pre- and post-surgery, assessed premorbid IQ and domains of attention, memory, and executive function. The primary outcome was defined as decline of ≥ 1 SD on ≥ 2 NP tests or decline of ≥ 2 SD on ≥ 1 test. Raw scores were transformed to Z-scores. RESULTS: NP testing was completed by 72 women, median age 72 (IQR 69-77) years. Procedures included 16 (22.9%) laparoscopic sacrocolpopexies, 23 (32.9%) transvaginal reconstructions, and 29 (41.4%) obliterative surgeries, performed under general (63, 90%), regional (5, 7.1%), or sedation (2, 2.9%) anesthesia with a median hospital stay of 0.6 (IQR 0.6-0.75) days. POCD incidence was 33.3% (n = 24). POCD was associated with greater frailty (p = 0.006) and higher baseline depression (p = 0.05) but not with older age (p = 0.77) or inhalational gas use (p = 1.0). CONCLUSION: In this cohort, one in three women manifested POCD 2 weeks after prolapse surgery. Preoperative counseling should include discussions on POCD given its detrimental impact on postoperative recovery and independence.

Immediate Postoperative Pelvic Organ Prolapse Quantification Measures and 2-Year Risk of Prolapse Recurrence.

OBJECTIVE: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction. METHODS: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored. RESULTS: This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9-2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1-2.3) and surgical failure (aOR 1.5; 95% CI 1.0-2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50-0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function. CONCLUSION: A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.