Surgical Outcomes in Benign Gynecologic Surgery Patients during the COVID-19 Pandemic (SOCOVID study).

STUDY OBJECTIVE: To determine the incidence of perioperative coronavirus disease (COVID-19) in women undergoing benign gynecologic surgery and to evaluate perioperative complication rates in patients with active, previous, or no previous severe acute respiratory syndrome coronavirus 2 infection. DESIGN: A multicenter prospective cohort study. SETTING: Ten institutions in the United States. PATIENTS: Patients aged >18 years who underwent benign gynecologic surgery from July 1, 2020, to December 31, 2020, were included. All patients were followed up from the time of surgery to 10 weeks postoperatively. Those with intrauterine pregnancy or known gynecologic malignancy were excluded. INTERVENTIONS: Benign gynecologic surgery. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the incidence of perioperative COVID-19 infections, which was stratified as (1) previous COVID-19 infection, (2) preoperative COVID-19 infection, and (3) postoperative COVID-19 infection. Secondary outcomes included adverse events and mortality after surgery and predictors for postoperative COVID-19 infection. If surgery was delayed because of the COVID-19 pandemic, the reason for postponement and any subsequent adverse event was recorded. Of 3423 patients included for final analysis, 189 (5.5%) postponed their gynecologic surgery during the pandemic. Forty-three patients (1.3% of total cases) had a history of COVID-19. The majority (182, 96.3%) had no sequelae attributed to surgical postponement. After hospital discharge to 10 weeks postoperatively, 39 patients (1.1%) became infected with severe acute respiratory syndrome coronavirus 2. The mean duration of time between hospital discharge and the follow-up positive COVID-19 test was 22.1 ± 12.3 days (range, 4-50 days). Eleven (31.4% of postoperative COVID-19 infections, 0.3% of total cases) of the newly diagnosed COVID-19 infections occurred within 14 days of hospital discharge. On multivariable logistic regression, living in the Southwest (adjusted odds ratio, 6.8) and single-unit increase in age-adjusted Charlson comorbidity index (adjusted odds ratio, 1.2) increased the odds of postoperative COVID-19 infection. Perioperative complications were not significantly higher in patients with a history of positive COVID-19 than those without a history of COVID-19, although the mean duration of time between previous COVID-19 diagnosis and surgery was 97 days (14 weeks). CONCLUSION: In this large multicenter prospective cohort study of benign gynecologic surgeries, only 1.1% of patients developed a postoperative COVID-19 infection, with 0.3% of infection in the immediate 14 days after surgery. The incidence of postoperative complications was not different in those with and without previous COVID-19 infections.

Route of Hysterectomy at the Time of Sacrocolpopexy: A Multicenter Retrospective Cohort Study.

OBJECTIVES: This study aimed to compare the incidence of mesh exposure based on route of hysterectomy at the time of minimally invasive sacrocolpopexy. Secondary outcomes included perioperative outcomes and prolapse recurrence. METHODS: This was a multicenter, retrospective cohort study. Patients who underwent sacrocolpopexy between 2007 and 2017 were stratified by hysterectomy approach: total vaginal hysterectomy (TVH), total laparoscopic or robotic hysterectomy (TLH), and laparoscopic or robotic supracervical hysterectomy (LSH). Total vaginal hysterectomy was subdivided into vaginal and laparoscopic mesh attachment to the cuff. Statistical analyses were performed, with P < 0.05 denoting statistical significance. RESULTS: Seven institutions participated, and 502 minimally invasive sacrocolpopexies with concomitant hysterectomy were performed by 23 surgeons: 263 TVH, 128 TLH, and 111 LSH. The median follow-up interval was 10 months, and this was significantly different between the groups (months): TVH, 11 (3-13); TLH, 2 (2-9); and LSH, 12 (5-24; P < 0.01). The overall incidence of vaginal mesh exposure was 4.0% (20/502). There were no significant differences in vaginal mesh exposure based on hysterectomy route: TVH, 5.7% (15/263); TLH, 1.6% (2/128); and LSH, 2.7% (3/111; P = 0.11). Within the TVH group, there was no significant difference in vaginal mesh exposure comparing vaginal and laparoscopic mesh attachment: 1.9% (1/52) versus 6.6% (14/211; P = 0.48). Laparoscopic supracervical hysterectomy demonstrated a significantly higher incidence of recurrence compared with TVH and TLH: 10.8% (12/111) versus 3.4% (9/263) and 2.3% (3/128; P < 0.01). CONCLUSIONS: The incidence of sacrocolpopexy mesh exposure was not significantly different based on route of hysterectomy or mode of mesh attachment to the vagina. There was a significant increase in prolapse recurrence with supracervical hysterectomy.

Outcomes of a single trigone-only vs. 20 trigone-sparing injections of OnabotulinumtoxinA for refractory overactive bladder (OAB).

PURPOSE: To compare the safety and durability of a single intravesical trigonal-only versus 20 trigone-sparing injections of OnabotulinumtoxinA (BTA) for refractory OAB. METHODS: A chart review of all idiopathic OAB patients treated with BTA from January 2016 to December 2018 was performed. Outcomes measures included: inter-injection interval, post-void residual (PVR), urinary tract infections (UTI), urinary retention requiring catheterization, and procedure time (min). Statistical analyses were performed using independent sample t-tests. RESULTS: Baseline characteristics were comparable for the two groups, data on 69 treatments (19 patients trigone-only) were compared to 105 treatments (26 patients trigone-sparing). There were no differences in the inter-injection intervals or rates of UTI. The trigone-only group exhibited a lower mean PVR (113 ml vs 160 ml, p < 0.02), lower proportion with PVR > 150 ml (23% vs. 39%, p < 0.03), lower rate of urinary retention (5.3% vs. 17.4%, p < 0.02), and shorter procedure time (4.3 min vs. 5.7 min, p < 0.01). There were no cases of vesico-ureteral reflux. CONCLUSION: While interpretation remains speculative, the results of this observational study suggest that a single trigone-only injection appears to be as safe and durable as multiple trigone-sparing injections but maybe quicker to perform and appears to have a lower impact on voiding function. Larger series and adequately powered prospective randomized clinical trials are warranted to validate the findings of this pilot study.

Vaginal Energy-Based Devices.

This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society's EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

Uterine-preserving surgeries for the repair of pelvic organ prolapse: a systematic review with meta-analysis and clinical practice guidelines.

INTRODUCTION AND HYPOTHESIS: We aimed to systematically review the literature on pelvic organ prolapse (POP) surgery with uterine preservation (hysteropexy). We hypothesized that different hysteropexy surgeries would have similar POP outcomes but varying adverse event (AE) rates. METHODS: MEDLINE, Cochrane, and clinicaltrials.gov databases were reviewed from inception to January 2018 for comparative (any size) and single-arm studies (n ≥ 50) involving hysteropexy. Studies were extracted for participant characteristics, interventions, comparators, outcomes, and AEs and assessed for methodological quality. RESULTS: We identified 99 eligible studies: 53 comparing hysteropexy to POP surgery with hysterectomy, 42 single-arm studies on hysteropexy, and four studies comparing stage ≥2 hysteropexy types. Data on POP outcomes were heterogeneous and usually from <3 years of follow-up. Repeat surgery prevalence for POP after hysteropexy varied widely (0-29%) but was similar among hysteropexy types. When comparing sacrohysteropexy routes, the laparoscopic approach had lower recurrent prolapse symptoms [odds ratio (OR) 0.18, 95% confidence interval (CI) 0.07-0.46), urinary retention (OR 0.05, 95% CI 0.003-0.83), and blood loss (difference -104 ml, 95% CI -145 to -63 ml) than open sacrohysteropexy. Laparoscopic sacrohysteropexy had longer operative times than vaginal mesh hysteropexy (difference 119 min, 95% CI 102-136 min). Most commonly reported AEs included mesh exposure (0-39%), urinary retention (0-80%), and sexual dysfunction (0-48%). CONCLUSIONS: Hysteropexies have a wide range of POP recurrence and AEs; little data exist directly comparing different hysteropexy types. Therefore, for women choosing uterine preservation, surgeons should counsel them on outcomes and risks particular to the specific hysteropexy type planned.

Uterine preservation vs hysterectomy in pelvic organ prolapse surgery: a systematic review with meta-analysis and clinical practice guidelines.

OBJECTIVE: We aimed to systematically review the literature on apical pelvic organ prolapse surgery with uterine preservation compared with prolapse surgeries including hysterectomy and provide evidence-based guidelines. DATA SOURCES: The sources for our data were MEDLINE, Cochrane, and clinicaltrials.gov databases from inception to January 2017. STUDY ELIGIBILITY CRITERIA: We accepted randomized and nonrandomized studies of uterine-preserving prolapse surgeries compared with those involving hysterectomy. STUDY APPRAISAL AND SYNTHESIS METHODS: Studies were extracted for participant information, intervention, comparator, efficacy outcomes, and adverse events, and they were individually and collectively assessed for methodological quality. If 3 or more studies compared the same surgeries and reported the same outcome, a meta-analysis was performed. RESULTS: We screened 4467 abstracts and identified 94 eligible studies, 53 comparing uterine preservation to hysterectomy in prolapse surgery. Evidence was of moderate quality overall. Compared with hysterectomy plus mesh sacrocolpopexy, uterine preservation with sacrohysteropexy reduces mesh exposure, operative time, blood loss, and surgical cost without differences in prolapse recurrence. Compared with vaginal hysterectomy with uterosacral suspension, uterine preservation in the form of laparoscopic sacrohysteropexy improves the C point and vaginal length on the pelvic organ prolapse quantification exam, estimated blood loss, postoperative pain and functioning, and hospital stay, but open abdominal sacrohysteropexy worsens bothersome urinary symptoms, operative time, and quality of life. Transvaginal mesh hysteropexy (vs with hysterectomy) decreases mesh exposure, reoperation for mesh exposure, postoperative bleeding, and estimated blood loss and improves posterior pelvic organ prolapse quantification measurement. Transvaginal uterosacral or sacrospinous hysteropexy or the Manchester procedure compared with vaginal hysterectomy with native tissue suspension both showed improved operative time and estimated blood loss and no worsening of prolapse outcomes with uterine preservation. However, there is a significant lack of data on prolapse outcomes >3 years after surgery, the role of uterine preservation in obliterative procedures, and longer-term risk of uterine pathology after uterine preservation. CONCLUSION: Uterine-preserving prolapse surgeries improve operating time, blood loss, and risk of mesh exposure compared with similar surgical routes with concomitant hysterectomy and do not significantly change short-term prolapse outcomes. Surgeons may offer uterine preservation as an option to appropriate women who desire this choice during apical prolapse repair.

Does Attorney Advertising Influence Patient Perceptions of Pelvic Mesh?

OBJECTIVE: To measure the relative influence of attorney advertising on patient perceptions of pelvic mesh compared with a history of surgery and a first urology visit. MATERIALS AND METHODS: A 52-item survey was administered to 170 female patients in 2 urology offices between 2014 and 2016. Multiple survey items were combined to form scales for benefit and risk perceptions of pelvic mesh, perceptions of the advertising, attitudes toward pelvic mesh, and knowledge of pelvic mesh and underlying medical conditions. Data were analyzed using hierarchical linear regression models. RESULTS: Exposure to attorney advertising was quite high; 88% reported seeing a mesh-related attorney advertisement in the last 6 months. Over half of patients reported seeing attorney advertisements more than once per week. A history of prior mesh implant surgery was the strongest predictor of benefit and risk perceptions of pelvic mesh. Exposure to attorney advertising was associated with higher risk perceptions but did not significantly affect perceptions of benefits. Past urologist visits increased perceptions of benefits but had no effect on risk perceptions. CONCLUSION: Attorney advertising appears to have some influence on risk perceptions, but personal experience and discussions with a urogynecologist or urologist also influence patient perceptions. Implications, limitations, and future research are discussed.

Quantitative Assessment and Interpretation of Vaginal Conditions.

INTRODUCTION: Few means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints. AIM: To develop a new approach for quantitative biomechanical characterization of the vagina. METHODS: Vaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction. RESULTS: Data were analyzed for 42 subjects with normal pelvic floor support from an observational case-controlled clinical study. The average age was 52 years (range = 26-90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (≤52 vs >52 years), which means 6 VTI parameters change with age. CONCLUSIONS: VTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding "normal" vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome. Egorov V, Murphy M, Lucente V, et al. Quantitative Assessment and Interpretation of Vaginal Conditions. Sex Med 2018;6:39-48.

Restrictions and limitations after pelvic floor surgery: what's the evidence?

PURPOSE OF REVIEW: A common concern regarding pelvic floor surgery is the relatively high risk of recurrence. In an effort to minimize this risk, many surgeons instruct their patients to avoid certain activities during the healing process so as not to damage the repair before proper healing has occurred. However, many of these restrictions have been historically based on little to no hard evidence. The purpose of this review is to present the latest evidence-based recommendations regarding restrictions and limitations after pelvic floor surgery. RECENT FINDINGS: The current review covers postoperative activities that could impact proper healing of a vaginal incision and of the strength of the reconstruction itself. It also looks at safety of the patient and those around her as she heals. Topics include pelvic rest, swimming, lifting exercising, working, and driving. Observational research suggests that many unavoidable activities of daily living may have as great, if not an even greater, risk of impacting the healing process than many of the modifiable activity restrictions that are commonly imposed on patients. This may explain why recent clinical trials show no greater problem with healing in patients randomized to less strict postoperative restrictions than the standard. SUMMARY: Although further research is necessary, it appears that patients are more satisfied with less strict postoperative limitations, and this less restrictive activity may not have any significant negative impact on the healing process.

Comparison of Vaginal Hysterectomy Techniques and Interventions for Benign Indications: A Systematic Review.

OBJECTIVE: To create evidence-based clinical practice guidelines based on a systematic review of published literature regarding the risks and benefits of available preoperative, intraoperative, and postoperative technical steps and interventions at the time of vaginal hysterectomy for benign indications. DATA SOURCES: We systematically searched the literature to identify studies that compared technical steps or interventions during the preoperative, intraoperative, and postoperative periods surrounding vaginal hysterectomy. We searched MEDLINE, Cochrane Central Register of Controlled Trials, Health Technology Assessments, and ClinicalTrials.gov from their inception until April 10, 2016, using the MeSH term "Hysterectomy, Vaginal" and associated text words. We included comparative studies, single-group studies, and systematic reviews published in English. METHODS OF STUDY SELECTION: We double-screened 4,250 abstracts, identifying 60 eligible studies. Discrepancies were adjudicated by a third reviewer. We followed standard systematic review methodology and the Grades for Recommendation, Assessment, Development and Evaluation approach to evaluate the evidence and generate guideline recommendations. TABULATION, INTEGRATION, AND RESULTS: Because of limited literature, only 16 perioperative risks, technical steps, and interventions were identified: obesity, large uteri, prior surgery, gonadotropin-releasing hormone agonists, vaginal antisepsis, bilateral salpingo-oophorectomy, morcellation, apical closure, uterine sealers, hemostatic injectants, hot cone, retractor, cystoscopy, vaginal packing, bladder management, and accustimulation. We organized and reported these as four domains: patient selection, preoperative, intraoperative, and postoperative. We did not identify any patient characteristics precluding a vaginal approach; chlorhexidine or povidone is appropriate for vaginal antisepsis; vasopressin decreases blood loss by 130 cc; tissue-sealing devices decrease blood loss by 44 cc and operative time by 15 minutes with uncertain complication implications; vertical cuff closure results in 1-cm increased vaginal length; either peritoneum or epithelium can be used for colpotomy closure; and routine vaginal packing is not advised. CONCLUSION: Minimal data exist to guide surgeons with respect to planning and performing a vaginal hysterectomy. This study identifies available information and future areas for investigation.

Salpingo-oophorectomy at the Time of Benign Hysterectomy: A Systematic Review.

OBJECTIVE: To compare the long-term risks associated with salpingo-oophorectomy with ovarian conservation at the time of benign hysterectomy. DATA SOURCES: MEDLINE, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials were searched from inception to January 30, 2015. We included prospective and retrospective comparative studies of women with benign hysterectomy who had either bilateral salpingo-oophorectomy (BSO) or conservation of one or both ovaries. METHODS OF STUDY SELECTION: Reviewers double-screened 5,568 citations and extracted eligible studies into customized forms. Twenty-six comparative studies met inclusion criteria. Studies were assessed for results, quality, and strength of evidence. TABULATION, INTEGRATION, AND RESULTS: Studies were extracted for participant, intervention, comparator, and outcomes data. When compared with hysterectomy with BSO, prevalence of reoperation and ovarian cancer was higher in women with ovarian conservation (ovarian cancer risk of 0.14-0.7% compared with 0.02-0.04% among those with BSO). Hysterectomy with BSO was associated with a lower incidence of breast and total cancer, but no difference in the incidence of cancer mortality was found when compared with ovarian conservation. All-cause mortality was higher in women younger than age 45 years at the time of BSO who were not treated with estrogen replacement therapy (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.04-1.92). Coronary heart disease (HR 1.26, 95% CI 1.04-1.54) and cardiovascular death were higher among women with BSO (HR 1.84, 95% CI 1.27-2.68), especially women younger than 45 years who were not treated with estrogen. Finally, there was an increase in the prevalence of dementia and Parkinson disease among women with BSO compared with conservation, especially in women younger than age 50 years. Clinical practice guidelines were devised based on these results. CONCLUSION: Bilateral salpingo-oophorectomy offers the advantage of effectively eliminating the risk of ovarian cancer and reoperation but can be detrimental to other aspects of health, especially among women younger than age 45 years.

Graft and Mesh Use in Transvaginal Prolapse Repair: A Systematic Review.

OBJECTIVE: To update clinical practice guidelines on graft and mesh use in transvaginal pelvic organ prolapse repair based on systematic review. DATA SOURCES: Eligible studies, published through April 2015, were retrieved through ClinicalTrials.gov, MEDLINE, and Cochrane databases and bibliography searches. METHODS OF STUDY SELECTION: We included studies of transvaginal prolapse repair that compared graft or mesh use with either native tissue repair or use of a different graft or mesh with anatomic and symptomatic outcomes with a minimum of 12 months of follow-up. TABULATION, INTEGRATION, AND RESULTS: Study data were extracted by one reviewer and confirmed by a second reviewer. Studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic absorbable, synthetic nonabsorbable), and outcome (anatomic, symptomatic, sexual function, mesh complications, and return to the operating room). We found 66 comparative studies reported in 70 articles, including 38 randomized trials; quality of the literature has improved over time, but some outcomes still show heterogeneity and limited power. In the anterior vaginal compartment, synthetic nonabsorbable mesh consistently showed improved anatomic and bulge symptom outcomes compared with native tissue repairs based on meta-analyses. Other subjective outcomes, including urinary incontinence or dyspareunia, generally did not differ. Biologic graft or synthetic absorbable mesh use did not provide an advantage in any compartment. Synthetic mesh use in the posterior or apical compartments did not improve success. Mesh erosion rates ranged from 1.4-19% at the anterior vaginal wall, but 3-36% when mesh was placed in multiple compartments. Operative mesh revision rates ranged from 3-8%. CONCLUSION: Synthetic mesh augmentation of anterior wall prolapse repair improves anatomic outcomes and bulge symptoms compared with native tissue repair. Biologic grafts do not improve prolapse repair outcomes in any compartment. Mesh erosion occurred in up to 36% of patients, but reoperation rates were low.

One-year functional and anatomic outcomes of robotic sacrocolpopexy versus vaginal extraperitoneal colpopexy with mesh.

OBJECTIVES: This study aimed to evaluate and compare 1-year anatomic and functional outcomes in patients undergoing transvaginal versus transabdominal repair of pelvic organ prolapse (POP) with synthetic mesh reinforcement. METHODS: We conducted a retrospective, matched cohort study of patients undergoing robotic-assisted laparoscopic sacrocolpopexy (RALSC) and vaginal extraperitoneal colpopexy (VEC) with synthetic mesh from December 2008 to March 2011. We compared the preoperative to postoperative changes in anatomic, quality of life, and functional outcomes between groups after 1 year of follow-up. One-year surgical satisfaction was also assessed. RESULTS: Thirty-eight RALSC patients met the inclusion criteria and were matched by age and month of surgery to 38 VEC patients. Of those, 31 RALSC and 30 VEC patients (80%) had complete 1-year data. Preoperative to postoperative outcomes were similar in both groups with similar improvement seen in anatomic Pelvic Organ Prolapse Quantification measures as well as functional questionnaire scores. Both groups demonstrated high surgical satisfaction. Symptom distress inventory scales revealed 84% and 90% resolution of symptomatic "bulge" in RALSC and VEC patients, respectively (P = 0.74). The RALSC group had a significantly greater operative time by approximately 96 minutes and greater use of general anesthesia (P = <0.001). No difference was noted in blood loss, hospital days, or return to normal voiding between groups. CONCLUSIONS: Transabdominal and transvaginal techniques of colpopexy using synthetic mesh implants for POP have been shown in this retrospective cohort study to improve quality of life and anatomic measures with similar outcomes. Robotic-assisted laparoscopic sacrocolpopexy results in a greater use of general anesthesia and longer operative time.

Vaginal estrogen use in postmenopausal women with pelvic floor disorders: systematic review and practice guidelines.

INTRODUCTION AND HYPOTHESIS: Risk of pelvic floor disorders increases after menopause and may be linked to estrogen deficiency. We aimed to systematically and critically assess the literature on vaginal estrogen in the management of pelvic floor disorders in postmenopausal women and provide evidence-based clinical practice guidelines. METHODS: MEDLINE and Cochrane databases were searched from inception to July 2014 for randomized controlled trials of commercially available vaginal estrogen products compared with placebo, no treatment, or any medication for overactive bladder or urinary incontinence. We double-screened 1,805 abstracts and identified 12 eligible papers. Studies were extracted for participant information, intervention, comparator, efficacy outcomes, and adverse events, and they were individually and collectively assessed for methodological quality and strength of evidence. RESULTS: Evidence was generally of poor to moderate quality. Vaginal estrogen application before pelvic organ prolapse surgery improved the vaginal maturation index and increased vaginal epithelial thickness. Postoperative vaginal estrogen use after a midurethral sling resulted in decreased urinary frequency and urgency. Vaginal estrogen and immediate-release oxybutynin were similar in improvement of urinary urgency, frequency, and urgency urinary incontinence in women with overactive bladder, but oxybutynin had higher rates of side effects and discontinuation. Conversely, the addition of vaginal estrogen to immediate or extended-release tolterodine did not improve urinary symptoms more than tolterodine alone. One study reported an improvement in stress urinary incontinence with use of vaginal estrogen. CONCLUSION: Vaginal estrogen application may play a useful role as an adjunct in the management of common pelvic floor disorders in postmenopausal women.

Vaginal estrogen for genitourinary syndrome of menopause: a systematic review.

OBJECTIVE: To comprehensively review and critically assess the literature on vaginal estrogen and its alternatives for women with genitourinary syndrome of menopause and to provide clinical practice guidelines. DATA SOURCES: MEDLINE and Cochrane databases were searched from inception to April 2013. We included randomized controlled trials and prospective comparative studies. Interventions and comparators included all commercially available vaginal estrogen products. Placebo, no treatment, systemic estrogen (all routes), and nonhormonal moisturizers and lubricants were included as comparators. METHODS OF STUDY SELECTION: We double-screened 1,805 abstracts, identifying 44 eligible studies. Discrepancies were adjudicated by a third reviewer. Studies were individually and collectively assessed for methodologic quality and strength of evidence. TABULATION, INTEGRATION, AND RESULTS: Studies were extracted for participant, intervention, comparator, and outcomes data, including patient-reported atrophy symptoms (eg, vaginal dryness, dyspareunia, dysuria, urgency, frequency, recurrent urinary tract infection (UTI), and urinary incontinence), objective signs of atrophy, urodynamic measures, endometrial effects, serum estradiol changes, and adverse events. Compared with placebo, vaginal estrogens improved dryness, dyspareunia, urinary urgency, frequency, and stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Urinary tract infection rates decreased. The various estrogen preparations had similar efficacy and safety; serum estradiol levels remained within postmenopausal norms for all except high-dose conjugated equine estrogen cream. Endometrial hyperplasia and adenocarcinoma were extremely rare among those receiving vaginal estrogen. Comparing vaginal estrogen with nonhormonal moisturizers, patients with two or more symptoms of vulvovaginal atrophy were substantially more improved using vaginal estrogens, but those with one or minor complaints had similar symptom resolution with either estrogen or nonhormonal moisturizer. CONCLUSION: All commercially available vaginal estrogens effectively relieve common vulvovaginal atrophy-related complaints and have additional utility in patients with urinary urgency, frequency or nocturia, SUI and UUI, and recurrent UTIs. Nonhormonal moisturizers are a beneficial alternative for those with few or minor atrophy-related symptoms and in patients at risk for estrogen-related neoplasia. CLINICAL TRIAL REGISTRATION: PROSPERO International prospective register of systematic reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42013006656.

Systematic review of robotic surgery in gynecology: robotic techniques compared with laparoscopy and laparotomy.

The Society of Gynecologic Surgeons Systematic Review Group performed a systematic review of both randomized and observational studies to compare robotic vs nonrobotic surgical approaches (laparoscopic, abdominal, and vaginal) for treatment of both benign and malignant gynecologic indications to compare surgical and patient-centered outcomes, costs, and adverse events associated with the various surgical approaches. MEDLINE and the Cochrane Central Register of Controlled Trials were searched from inception to May 15, 2012, for English-language studies with terms related to robotic surgery and gynecology. Studies of any design that included at least 30 women who had undergone robotic-assisted laparoscopic gynecologic surgery were included for review. The literature yielded 1213 citations, of which 97 full-text articles were reviewed. Forty-four studies (30 comparative and 14 noncomparative) met eligibility criteria. Study data were extracted into structured electronic forms and reconciled by a second, independent reviewer. Our analysis revealed that, compared with open surgery, robotic surgery consistently confers shorter hospital stay. The proficiency plateau seems to be lower for robotic surgery than for conventional laparoscopy. Of the various gynecologic applications, there seems to be evidence that renders robotic techniques advantageous over traditional open surgery for management of endometrial cancer. However, insofar as superiority, conflicting data are obtained when comparing robotics vs laparoscopic techniques. Therefore, the specific method of minimally invasive surgery, whether conventional laparoscopy or robotic surgery, should be tailored to patient selection, surgeon ability, and equipment availability.

Postoperative management and restrictions for female pelvic surgery: a systematic review.

INTRODUCTION AND HYPOTHESIS: We sought to systematically review the literature regarding the effect of postoperative restrictions on clinical outcomes after pelvic surgery. METHODS: English-language articles were identified by a MEDLINE and Cochrane Central Register of Controlled Trials search from inception to July 2010. We used key words describing various gynecologic surgical procedures and postoperative activities, including mobility, lifting, work, coitus, and exercise. Randomized and nonrandomized studies comparing interventions with outcomes of interest were included. RESULTS: The literature search yielded of 3,491 articles; 115 full-text articles were reviewed, and 38 met eligibility criteria and are reported and analyzed here. Our analysis revealed that expedited discharge protocols and early postoperative feeding and catheter removal result in shorter hospital stay without negative health outcomes. However, there are limited data to guide many other aspects of postoperative care, particularly regarding exercise and resumption of sexual activity after surgery. CONCLUSIONS: There is good evidence to support early postoperative feeding and catheter removal after pelvic surgery. There are limited data to guide many other aspects of postoperative care.

Risk factors for mesh extrusion after prolapse surgery: a case-control study.

OBJECTIVES: To identify risk factors for mesh extrusion in women undergoing pelvic organ prolapse repair by abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP). METHODS: A multicenter case-control study of patients who underwent ASC or VMP from 2006 to 2009 identified using diagnosis and procedure coding. Cases were defined as women who underwent eligible index procedure with synthetic mesh and had mesh visible through the vaginal epithelium at postoperative evaluation; controls were matched in an approximate 1:3 ratio by date and type of procedure. Two conditional logistic regression models were constructed to assess variables associated with mesh extrusion among women who underwent ASC and among women who underwent VMP. RESULTS: Eighty-four cases were identified (43 cases after ASC and 41 cases after VMP), and 252 patients were matched as controls (147 patients who underwent ASC and 105 patients who underwent VMP). Concomitant hysterectomy was positively associated with mesh extrusion) among women who underwent ASC (adjusted odds ratio, 3.18; 95% confidence interval, 1.27-7.93; P = 0.01) and VMP (adjusted odds ratio, 3.72, 95% confidence interval, 1.20-11.54; P = 0.02). Age, race, type of vaginal incision, menopausal status, medical comorbidities, and smoking were not significantly associated with extrusion in either group. CONCLUSIONS: Concomitant hysterectomy is a risk factor for mesh extrusion after ASC and VMPs. This information may be helpful during informed preoperative counseling and planning.

Vaginal prolapse repair: suture repair versus mesh augmentation: a urogynecology perspective.

Based on the growing evidence within our literature, mesh is clearly needed for long-term success for the repair of anterior/apical defects. Clear credentialing and clinical privilege criteria policies are long overdue. Current data are rapidly growing, with level I studies completed that demonstrate that when transvaginal mesh-augmented repair is used in appropriately selected patients for the repair of pelvic organ prolapse, the procedure has a favorable risk/benefit ratio when compared with suture repair. This article highlights the evolving clinical-based experiences of the authors that are primarily grounded in reality-based medicine with the consideration and incorporation of evidence-based medicine.

Psychometric evaluation of health-related quality-of-life measures after pelvic organ prolapse surgery.

OBJECTIVE: To evaluate the psychometric characteristics of the Pelvic Floor Distress Inventory (PFDI-20), the Pelvic Floor Impact Questionnaire (PFIQ-7), and the Patient Global Impression of Change (PGIC) among women undergoing pelvic organ prolapse (POP) repair surgery. METHODS: Data were collected at baseline and 12 months from 2 single-arm trials of surgical repair of POP using mesh. At each time point, internal consistency reliability (Cronbach's α) was calculated for the PFDI-20 and PFIQ-7 total scores and for each subscale. Concurrent validity was assessed with baseline and follow-up data using Spearman's rank-order correlation coefficients. Responsiveness was assessed by calculating change scores from baseline to each follow-up visit, effect sizes, standard error of measurement (SEM), and using PFDI-20 and PFIQ-7 change scores stratified by PGIC. RESULTS: The women (N=275: study 1, n=148; study 2, n=127) had a mean (SD) of 64.4 (10.3) years of age. At baseline, the women had a mean (SD) stage II (n=83), stage III (n=173), or stage IV (n=19) POP quantification. At baseline, the internal consistency reliability of the PFDI-20 full and subscales ranged from 0.64 to 0.85, and that of the PFIQ-7 ranged from 0.89 to 0.96. Concurrent validity was good for the PFDI-20 and PFIQ-7 (r range, 0.35-0.59). The PFDI-20, the PFIQ-7, and the PGIC were responsive. CONCLUSION: The PFDI-20, the PFIQ-7, and the PGIC are psychometrically sound measures of patients' perceptions of change after POP surgery and will be useful for those interested in evaluating perceptions of patients undergoing surgical POP repair.