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This clinical consensus statement on vaginal energy-based devices (EBDs) reflects an update by content experts from the American Urogynecologic Society's EBD writing group. In 2019, 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. In March 2022, these statements were reassessed using the interim literature.

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.

To compare the safety and effectiveness of transvaginal mesh repair and native tissue repair, in response to a U.S. Food and Drug Administration (FDA) 522 study order to assess co-primary endpoints of superiority and noninferiority.This was a prospective, nonrandomized, parallel cohort, multi-center trial comparing transvaginal mesh with native tissue repair for the treatment of pelvic organ prolapse. The primary endpoints were composite treatment success at 36 months comprised of anatomical success (defined as pelvic organ prolapse quantification [POP-Q] point Ba≤0 and/or C≤0), subjective success (vaginal bulging per the PFDI-20 [Pelvic Floor Distress Inventory]), and retreatment measures, as well as rates of serious device-related or serious procedure-related adverse events. Secondary endpoints included a composite outcome similar to the primary composite outcome but with anatomical success defined as POP-Q point Ba0 and/or C0, quality-of-life measures, mesh exposure and mesh- and procedure-related complications. Propensity score stratification was applied.Primary endpoint composite success at 36 months was 89.3% (201/225) for transvaginal mesh and 80.2% (389/485) for native tissue repair, demonstrating noninferiority at the preset margin of 12% (propensity score-adjusted treatment difference 6.5%, 90% CI -0.2% to 13.2%). Using the primary composite endpoint, transvaginal mesh was not superior to native tissue repair (P=.056). Using the secondary composite endpoint, superiority of transvaginal mesh over native tissue repair was noted (P=.009), with a propensity score-adjusted difference of 10.6% (90% CI 3.3-17.9%) in favor of transvaginal mesh. Subjective success for both the primary and secondary endpoint was 92.4% for transvaginal mesh, 92.8% for native tissue repair, a propensity score-adjusted difference of -4.3% (CI -12.3% to 3.8%). For the primary safety endpoint, 3.1% (7/225) of patients in the transvaginal mesh (TVM) group and 2.7% (13/485) of patients in the native tissue repair (NTR) group developed serious adverse events, demonstrating that transvaginal mesh was noninferior to native tissue repair (-0.4%, 90% CI -2.7% to 1.9%). Overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) in the TVM group and 46.4% (225/485) in the NTR group (-15.7%, 95% CI -24.0% to -7.5%).Transvaginal mesh repair for the treatment of anterior and/or apical vaginal prolapse was not superior to native tissue repair at 36 months. Subjective success, an important consideration from the patient-experience perspective, was high and not statistically different between groups. Transvaginal mesh repair was as safe as native tissue repair with respect to serious device-related and/or serious procedure-related adverse events.This study was sponsored by Boston Scientific and developed in collaboration with FDA personnel from the Office of Surveillance and Biometrics, Division of Epidemiology.ClinicalTrials.gov, NCT01917968.

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.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 P0.05 denoting statistical significance.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; P0.01). 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; P0.01).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.

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.

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. 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. 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

To compare the safety and durability of a single intravesical trigonal-only versus 20 trigone-sparing injections of OnabotulinumtoxinA (BTA) for refractory OAB. 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. 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 150 ml (23% vs. 39%, p

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.

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.

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.

Vincent Lucente,1 Heather van Raalte,2 Miles Murphy,1 Vladimir Egorov3 1The Institute for Female Pelvic Medicine and Reconstructive Surgery, Allentown, PA, USA; 2Princeton Urogynecology, Princeton, NJ, USA; 3Artann Laboratories, Trenton, NJ, USA Background: Further progress in restoring a woman’s health may be possible if a patient with a damaged pelvic floor could undergo medical imaging and biomechanical diagnostic tests. The results of such tests could contribute to the analysis of multiple treatment options and suggest the optimal one for that patient.Aim: To develop a new approach for the biomechanical characterization of vaginal conditions, muscles, and connective tissues in the female pelvic floor.Methods: Vaginal tactile imaging (VTI) allows biomechanical assessment of the soft tissue along the entire length of the anterior, posterior, and lateral vaginal walls at rest, with manually applied deflection pressures and with muscle contraction, muscle relaxation, and Valsalva maneuver. VTI allows a large body of measurements to evaluate individual variations in tissue elasticity, support defects, as well as pelvic muscle function. Presuming that 1) the female pelvic floor organs are suspended by ligaments against which muscles contract to open or close the outlets and 2) damaged ligaments weaken the support and may reduce the force of muscle contraction, we made an attempt to characterize multiple pelvic floor structures from VTI data.Results: All of the 138 women enrolled in the study were successfully examined with the VTI. The study subjects have had normal pelvic support or pelvic organ prolapse (stages I–IV). The average age of this group of subjects was 60±15 years. We transposed a set of 31 VTI parameters into a quantitative characterization of pelvic muscles and ligamentous structures. Interpretation of the acquired VTI data for normal pelvic floor support and prolapse conditions is proposed based on biomechanical assessment of the functional anatomy.Conclusion: Vaginal tactile imaging allows biomechanical characterization of female pelvic floor structures and tissues in vivo, which may help to optimize treatment of the diseased conditions such as prolapse, incontinence, atrophy, and some forms of pelvic pain. Keywords: female pelvic floor, biomechanics, diagnostic, treatment, tactile imaging, tissue elasticity, pelvic muscles

The novel coronavirus (COVID-19) pandemic has had a major impact on how patients are evaluated and treated for diseases and conditions in normal patient care Due to lack of effective treatments for this virus or vaccines to prevent infection, focus is placed on infection prevention through use of social distancing, quarantine, and face masks To prevent COVID-19 infections in healthcare settings, the Centers for Disease Control and Prevention has recommended decreasing or eliminating nonurgent office visits Telehealth has emerged as an alternative way to deliver effective patient care, while reducing patient and physician exposure to the virus Telehealth is any remote healthcare process, including provider training or team meetings, whereas telemedicine refers to use of specific technology to connect a patient to a provider High quality of care can and must be provided by Female Pelvic Medicine and Reconstructive Surgeons (FPMRS) as well as other specialists and health professionals using telemedicine Because of the health care emergency during the pandemic, the Centers for Medicare and Medicaid Services have broadened access to and reimbursement for telemedicine services Rapid advances in communications technology and widespread wireless access in many modern households have allowed the adoption and integration of telemedicine into urogynecology and other health practices There are no clear guidelines for the use of telemedicine in FPMRS The aim of this study was to conduct an expedited review of the evidence and to provide guidance for managing common outpatient FPRMS conditions during the COVID pandemic using telemedicine FPMRS conditions were grouped into those that likely to require different treatment with virtual management compared with in-person visits, and those that could use accepted behavioral counseling and not deviate from current management paradigms Rapid systematic review methodology was used to screen for articles related to 4 topics: (1) telemedicine in FPMRS, (2) pessary management, (3) urinary tract infections, and (4) urinary retention In addition, 4 other topics were addressed (based on past systematic reviews and national or international society guidelines): (1) urinary incontinence, (2) vaginal prolapse, (3) fecal incontinence, and (4) defecatory dysfunction Finally, clinical experience and expertise were pooled to reach consensus on 4 remaining areas: (1) FPMRS conditions amenable to virtual management, (2) urgent care scenarios requiring in-person visits, (3) symptoms that should alert providers to a possible COVID infection, and (4) special consideration for managing patients with known or suspected COVID-19 Overall, behavioral, medical, and conservative management provided in a virtual setting (via phone or Internet communication) will be valuable as first-line treatments Certain situations were identified that require different treatments in the virtual setting than in person, whereas others were shown to require an in-person visit despite risks of COVID-19 exposure and spread of infection This study presents guidance for treating FPMRS conditions via telemedicine in a format that can be actively referenced The strengths of the study include use of an expedited review method, extensive experience of the authors in conducting systematic reviews, as well as being seasoned FPMRS practitioners Main limitations include the rapid methodology, lack of data regarding many of the pertinent questions, and missed salient studies, because of the expedited evidence methods

Quantitative biomechanical characterization of pelvic supportive structures and functions in vivo is thought to provide insight into the pathophysiology of pelvic floor disorders including pelvic organ prolapse (POP). An innovative approach - vaginal tactile imaging - allows biomechanical mapping of the female pelvic floor to quantify tissue elasticity, pelvic support, and pelvic muscle functions. The objective of this study is to explore an extended set of 52 biomechanical parameters to characterize pelvic floor changes with age, parity, and subject weight for normal pelvic floor conditions. 42 subjects with normal pelvic conditions (no POP, no stress urinary incontinence) were included in the data analysis from an observational, case-controlled study. The Vaginal Tactile Imager (VTI) was used with an analytical software package to automatically calculate 52 biomechanical parameters for 8 VTI test procedures (probe insertion, elevation, rotation, Val-salva maneuver, voluntary muscle contractions in 2 planes, relaxation, and reflex contraction). The ranges, mean values, and standard deviations for all 52 VTI parameters were established. 12 VTI parameters were identified as statistically sen-sitive (p < 0.05; t-test) to the subject age; 9 parameters were identified as statistically sensitive (p < 0.05; t-test) to the subject parity; no sensitivity was found to subject weight. Among the 12 parameters sensitive to women’s age, 6 parameters show changes (decrease) in tissue elasticity and 6 parameters show weakness in pelvic muscle functions with age. Among the 9 parameters sensitive to parity, 5 parameters show changes (decrease) in tissue elasticity and 4 parameters show weakness in pelvic muscle functions after giving birth. The biomechanical mapping of the female pelvic floor with the VTI provides a unique set of parameters characterizing pelvic changes with age and parity. These objectively measurable biomechanical transformations of pelvic tissues, support structures, and functions may be used in future research and practical applications.

The purpose of the study was to determine the efficacy and safety of nonantimuscarinic treatments for overactive bladder. Medline, Cochrane, and other databases (inception to April 2, 2014) were used. We included any study design in which there were 2 arms and an n > 100, if at least 1 of the arms was a nonantimuscarinic therapy or any comparative trial, regardless of number, if at least 2 arms were nonantimuscarinic therapies for overactive bladder. Eleven reviewers double-screened citations and extracted eligible studies for study: population, intervention, outcome, effects on outcome categories, and quality. The body of evidence for categories of interventions were summarized and assessed for strength. Ninety-nine comparative studies met inclusion criteria. Interventions effective to improve subjective overactive bladder symptoms include exercise with heat and steam generating sheets (1 study), diaphragmatic (1 study), deep abdominal (1 study), and pelvic floor muscle training exercises (2 studies). Pelvic floor exercises are more effective in subjective and objective outcomes with biofeedback or verbal feedback. Weight loss with diet and exercise, caffeine reduction, 25-50% reduction in fluid intake, and pelvic floor muscle exercises with verbal instruction and or biofeedback were all efficacious. Botulinum toxin A improves urge incontinence episodes, urgency, frequency, quality of life, nocturia, and urodynamic testing parameters. Acupuncture improves quality of life and urodynamic testing parameters. Extracorporeal magnetic stimulation improves urodynamic parameters. Mirabegron improves daily incontinence episodes, nocturia, number of daily voids, and urine volume per void, whereas solabegron improves daily incontinence episodes. Short-term posterior tibial nerve stimulation is more efficacious than pelvic floor muscle training exercises and behavioral therapy for improving: urgency, urinary incontinence episodes, daily voids, volume per void, and overall quality of life. Sacral neuromodulation is more efficacious than antimuscarinic treatment for subjective improvement of overactive bladder and quality of life. Transvaginal electrical stimulation demonstrates subjective improvement in overactive bladder symptoms and urodynamic parameters. Multiple therapies, including physical therapy, behavioral therapy, botulinum toxin A, acupuncture, magnetic stimulation, mirabegron, posterior tibial nerve stimulation, sacral neuromodulation, and transvaginal electrical stimulation, are efficacious in the treatment of overactive bladder.

To update clinical practice guidelines on graft and mesh use in transvaginal pelvic organ prolapse repair based on systematic review.Eligible studies, published through April 2015, were retrieved through ClinicalTrials.gov, MEDLINE, and Cochrane databases and bibliography searches.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.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%.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.

While the transvaginal placement of synthetic mesh has been used to treat pelvic floor disorders for over 20 years, this surgical technique is still a point of deliberation among experts in the field. Placing mesh through a vaginal incision for the treatment of stress incontinence is widely considered to be the standard procedure for surgical treatment of this condition. However, new techniques – such as single-incision slings – are still somewhat controversial. Vaginal mesh for prolapse is perhaps one of the most debated surgical techniques in gynecology since the turn of the millennium, with one of the common criticisms being that there is a paucity of quality outcome data associated with this technique. The goal of this chapter is to review and interpret these outcomes.

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.

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.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.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.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.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.PROSPERO International prospective register of systematic reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42013006656.

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.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.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.Vaginal estrogen application may play a useful role as an adjunct in the management of common pelvic floor disorders in postmenopausal women.

Objective The objective of the study was to investigate the effectiveness of preemptive analgesia at pain control in women undergoing total abdominal hysterectomy. Data Sources Eligible studies, published through May 31, 2016, were retrieved through Medline, Cochrane Central Register for Controlled Trials, and Cochrane Database of Systematic Reviews. Study Eligibility We included randomized controlled trials with the primary outcome of pain control in women receiving a preemptive medication prior to total abdominal hysterectomy. Comparators were placebo, different doses of the same medication as intervention, or other nonnarcotic or narcotic medication. Study Appraisal and Synthesis Methods Study data were extracted by one reviewer and confirmed by a second reviewer. For each outcome we graded the quality of the evidence. Studies were classified by the type of medication used and by outcome type. Results Eighty-four trials met eligibility, with 69 included. Among nonnarcotic medications, paracetamol, gabapentin, and rofecoxib combined with gabapentin resulted in improvements in pain assessment compared with placebo and other nonnarcotic medications. Patient satisfaction was higher in patients who were given gabapentin combined with paracetamol compared with gabapentin alone. Use of preemptive paracetamol, gabapentin, bupivacaine, and phenothiazine resulted in less narcotic usage than placebo. All narcotics (ketamine, morphine, fentanyl) resulted in improved pain control compared with placebo. Narcotics had a greater reduction in pain assessment scores compared with nonnarcotics, and their use resulted in lower total narcotic usage. Conclusion Preemptive nonnarcotic and narcotic medications prior to abdominal hysterectomy decrease total narcotic requirements and improve patient postoperative pain assessment and satisfaction scores.

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.

We sought to systematically review the literature regarding the effect of postoperative restrictions on clinical outcomes after pelvic surgery. 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. 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. 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.

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.

To compare the long-term risks associated with salpingo-oophorectomy with ovarian conservation at the time of benign hysterectomy.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.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.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.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.

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

The primary objective was to determine the feasibility of a vaginal approach to sacrocolpopexy using a cadaver model. Secondary objectives were to measure the distance from the vaginal introitus to the sacrum and distances of the sacral fixation elements to other vital structures. Fourteen fresh-frozen cadavers were used. Specialized instruments were developed to optimize visualization and facilitate performance of the procedure. Five cadavers had a transperineal approach (an approach found unfeasible), and eight of the remaining nine had complete or partial completion of the transvaginal approach. The mean distance from the introitus to the promontory was 14.6 cm (12–16.5 cm). The mean distance from the sacral fixation elements to the aorta was 5.2 cm; common iliac artery, 3.5 cm; internal iliac artery, 3.25 cm; middle sacral artery, 1.75 cm, and ureters, 3.5 cm. The position of the sacral fixation elements was consistently at the level of S1–2. Vaginal sacrocolpopexy is feasible in a cadaver model.

OBJECTIVES : The purpose of this study was to determine outcomes of sling revision after midurethral sling (MUS) placement and whether timing of sling revision affected those outcomes. MATERIALS AND METHODS : This is a multicenter study including patients who underwent MUS placement and subsequent sling revision secondary to voiding dysfunction. Diagnostic outcomes before and after sling revision were compared for all sling revision patients with complete data. Logistic regression analyses were performed to determine if revision timing predicted voiding dysfunction and stress incontinence. RESULTS : One hundred seventy-five patients who met the study criteria had complete data. Overall, 70% (133) of MUS were retropubic and 30% (56) were obturator slings. Midurethral sling revision was accomplished by cutting (54%), excision (29%), and pulling down on the mesh (18%). Stress urinary incontinence (SUI) resolved in 38%, urinary tract infections (UTIs) in 69%, and overactive bladder (OAB) in 75%. In comparison, 21% experienced de novo SUI; 18%, de novo UTIs; and 12%, de novo OAB symptoms after revision. Voiding dysfunction resolved in 80%, however 10% experienced new voiding dysfunction symptoms. Retropubic slings displayed more voiding dysfunction, higher de novo/worsened OAB, and more UTIs after revision than obturator slings. Sling revision timing did not predict persistent voiding dysfunction but did predict SUI with earlier revision (≤2 weeks) resulting in less postrevision SUI when compared to revisions at 15-90 days or greater than 90 days. The method of sling revision (cut, excised, pulled down) did not predict SUI, OAB, or obstructive voiding symptoms. CONCLUSIONS : Sling revision resolves voiding dysfunction symptoms, UTIs and post-sling OAB symptoms in the majority of patients. Resolution of voiding dysfunction is independent of method and timing of revision; however earlier revision is associated with decreased postrevision SUI.

To determine risk factors for sling revision after midurethral sling (MUS) placement.This multicenter case-control study included patients who underwent MUS placement and subsequent revision secondary to voiding dysfunction from January 1999-2007 from nine Urogynecology centers across the USA. Direct logistic regression analysis was used to determine which diagnostic variables predicted sling revision.Of the patients, 197 met the study criteria. Patient demographics, urodynamic findings, and operative differences did not increase the risk for sling revision. Risk factors for sling revision did include: pre-existing voiding symptoms (OR 2.76, 95% CI 1.32-5.79; p = 0.004) retropubic sling type (OR = 2.28, 95% CI 1.08-4.78; p = 0.04) and concurrent surgery (OR = 4.88, 95% CI 2.16-11.05; p0.001)This study determined that pre-existing obstructive voiding symptoms, retropubic sling type, and concurrent surgery at the time of sling placement are risk factors for sling revision.

In this study, patients who underwent tension-free vaginal tape placement (TVT) under general anesthesia, when no cough-stress test was done, were compared with those who underwent the procedure with local anesthesia in which the cough-stress test was used to aid in adjusting the sling placement. The data from a cohort of 170 women, which was established for a previous investigation, were used to retrospectively examine patient outcomes according to the method of anesthesia. Sandvik's Incontinence Severity Index (ISI), the short form of the Incontinence Impact Questionnaire (IIQ-7), and the short form of the Urogenital Distress Inventory (UDI-6) were used for outcome evaluation. These 3 questionnaires had been mailed to all subjects before their initial surgery. For this study, patients were contacted and asked to complete the forms once again to gain subjective information about surgical outcomes. The Stress Symptoms subscale of the UDI was considered the primary outcome measure. Of the 170 original patients, 11 had received regional anesthesia and were not included. One hundred four of the remaining women could be contacted and completed both sets of questionnaires. Seventy-four (46.5%) of these patients underwent TVT with general anesthesia and 85 (53.5%) had local anesthesia. The Obstructive/Discomfort Symptoms subscale of the UDI was the only individual measurement that did not show significant improvement from the preoperative score. Significant improvement in all other areas was reported by both groups. However, on some measures, women who had local anesthesia showed significantly greater improvement than those who had general anesthesia. In the UDI-Stress Symptoms subscale, improvement in the mean score was 16.6 points higher for women who had local anesthesia compared with the general anesthesia group (P = .02 for difference). The results of the ISI demonstrated greater improvement in the severity of incontinence symptoms for patients who had local versus those who had general anesthesia (P = .02). In the postoperative evaluation, patients were asked if they had undergone any corrective surgery to loosen or "take down" a tight TVT tape. No patient reported any such surgery, although investigators knew of 2 women who had a "takedown" while under their care.

To determine whether the mode of anesthesia used during the tension-free vaginal tape procedure affects postoperative voiding function.A retrospective cohort study was performed using cases in which tension-free vaginal tape placement was the sole procedure performed. Of the 173 cases reviewed, we were able to use the data from 163. Hierarchal linear regression was used to identify independent predictors of our dependent variable: days to complete voiding. In the first block, established predictors of postoperative voiding dysfunction were entered into the model. In the second block, potential confounders of the relationship between anesthesia type and days to complete voiding identified during univariate analysis (P.15) were entered into the model. In the third block, anesthesia type was entered into the model to determine whether it added any unique variance after controlling for previously established predictors of postoperative voiding dysfunction.The mean days to complete voiding was similar in our local or regional anesthesia (n = 90) and general anesthesia groups (n = 73) (2.3 [0-21] versus 2.3 [0-14], P =.95). Our final regression model (F = 2.74, P =.011) included age, prior pelvic organ prolapse surgery, and preoperative urge symptoms and explained 22.2% of the variance in days to complete voiding. Anesthesia type did not add any predictive improvement after controlling for these variables.General anesthesia, and therefore lack of a cough-stress test, does not increase the chance of postoperative voiding dysfunction associated with tension-free vaginal tape.

model. METHODS: In 12 unembalmed cadavers, four polytetra.fluoroethylene sutures were placed through the uterosacral ligaments. In each cadaver, two sutures were placed laparoscopically, and two more were placed vaginally. A single, experienced surgeon placed alliaparoscopic sutures (n = 23), and another experienced surgeon placed all vaginal sutures (n = 22). A blinded team of investigators measured the distance from each suture to the ipsilateral ischial spine; determined whether any sutures incorporated ureters, viscera, or large vessels; and then passed the sutures through an apical vaginal incision. Using a hand-held tensiometer, progressive tensile load was then applied to these sutures along the axis of the vagina until they either broke or were completely dislodged from the ligaments. RESULTS: The average peak tension required to break or dislodge the sutures was 26.2 :t 8.8 psi (Iaparoscopic) and 22.5 :t 7.4 psi (vaginal) (P = .14,95% confidence interval [CI] -1.2, 8.6). The average force required for suture breakage (n = 28) was 28 :t 7 psi, and the average force applied when ligament failure occurred (n = 17) was 18.5 :t 6 psi (P < .001, 95% CI -13.8, -5.2). The average distance from a laparoscopic or vaginal suture to the ipsilateral ischial spine was 19.1 :t 7 mm and 17.4 :t 6 mm, respectively (P = .46,95% CI -3.0, 6.4). None of the sutures from either technique were found to incorporate a visceral structure, ureter, or great vessel. CONCLUSION: These suturing techniques appear to be equal in tensile strength. (Obstet Gynecol 2003;101:500-3. @ 2003 by The American College of Obstetricians and Gynecologists.)

Objective: The aim was to determine the minimum meaningful study period required for prospective trials involving sacral colpopexy. Study Design: This is a retrospective analysis of 245 patients who underwent sacral colpopexy. Postoperative pelvic organ prolapse quantitation was our objective end point. In an effort to control for selection bias, patients who returned for postoperative examinations were compared with those who did not for clinical and demographic information. A validated prolapse-specific quality of life instrument was used to determine the subjective end points. Results: Objective failure (any postoperative POP-Q point ≥ stage II) was found in 37 (15.1%) patients. Of these, 26 (70.3%) occurred within 6 months, and 30 (81.1%) occurred within 1 year. Another 5 objective failures were discovered between 1 and 2 years after surgery for a total of 94.6% of failures occurring within 2 years. There were no clinically significant differences between the groups of women with and without objective postoperative follow-up, indicating minimal selection bias. Conclusion: It is reasonable to construct randomized controlled trials involving sacral colpopexy that only include 1- or 2-year follow-up. (Am J Obstet Gynecol 2002;187:1473-82.)

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 =

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.

Objective To evaluate the interobserver reliability of pulmonary radiographic findings in patients with community-acquired pneumonia (CAP). Design A prospective, multicenter study. Setting Physician offices, medical walk-in clinics, emergency departments, and inpatient wards affiliated with three university hospitals, one community hospital, and one staff model health maintenance organization in three geographic areas. Methods Copies of the initial chest radiograph of patients suspected of having CAP were independently read by two staff radiologists at the coordinating university hospital. Interobserver reliability for the interpretation for radiographic findings was assessed by calculation of agreement rates and the kappa statistic. Participants Adults (age ≥18 years) with symptoms or signs of CAP and a pulmonary radiographic infiltrate documented by a local study site radiologist. Results Among the 282 patients whose initial pulmonary radiographs were evaluated, there was agreement between the two staff radiologists on the presence of infiltrate in 79.4% and on the absence of an infiltrate in 6.0% (kappa=0.37; 95% confidence interval [CI]=0.22 to 0.52). For the 224 patients with an infiltrate identified by both radiologists, there was further agreement that the infiltrate was unilobar in 41.5% and multilobar in 33.9% (kappa=0.51; 95% CI=0.28 to 0.62), pleural effusion was present in 10.7% and absent in 73.2% (kappa=0.46; 95% CI=0.33 to 0.50), and the infiltrate was alveolar in 96.3% of patients and interstitial in no patients (kappa=-0.01; 95% CI=-0.03 to 0.00). Among the 210 patients with an alveolar infiltrate, both radiologists classified the infiltrate as lobar in 74.6% and bronchopneumonia in 2.4% (kappa=0.09; 95% CI=-0.04 to 0.22), and agreed on the presence of air bronchograms in 7.6% and their absence in 52.9% (kappa=0.01; 95% CI=-0.13 to 0.15). Conclusion In patients with CAP, two university radiologists identified the presence of infiltrate, multilobar disease, and pleural effusion with fair to good interobserver reliability. However, interobserver reliability for the pattern of infiltrate and the presence of air bronchograms was poor.

The transobturator posterior anal sling (TOPAS) system is a posterior anal sling that is a minimally invasive, self-fixating polypropylene mesh intended to treat fecal incontinence (FI) in women who have failed conservative therapy.We are reporting 1-year outcome in a prospective, multicenter study under investigational device exemption, evaluating this new treatment modality.A total of 152 women were implanted with the TOPAS system at 14 centers in the United States. FI was assessed preoperatively and at the 12-month follow up with a 14-day bowel diary, Cleveland Clinic Incontinence Scores, and FI Quality of Life questionnaires. Treatment success was defined as reduction in number of FI episodes of ≥50% compared to baseline. Missing bowel diary data were considered treatment failures. The Wilcoxon signed rank test was used to compare changes observed at 12 months vs baseline.Mean age was 59.6 years old (SD 9.7). The mean duration of FI was 110 mo (range 8-712) months. Mean length of the implant procedure was 33.4 (SD 11.6) minutes. Mean EBL was 12.9 (SD 10.5) mL. Average follow-up was 24.9 months. At 12 months, 69.1% of patients met the criteria for treatment success, and 19% of subjects reported complete continence. FI episodes/wk decreased from a median of 9.0 (range 2-40) at baseline to 2.5 (range 0-40) (P.001). FI days decreased from a median of 5.0 (range 1.5-7) at baseline to 2.0 (range 0-7) (P.001) over a 7-day period. FI associated with urgency decreased from a median at baseline of 2.0 (range 0-26) to 0 (range 0-14.5) (P.001). The mean Cleveland Clinic Incontinence Scores decreased from 13.9 at baseline to 9.6 at 12 months (P.001). FI Quality of Life scores for all 4 domains improved significantly from baseline to 12 months (P.001). A total of 66 subjects experienced 104 procedure- and/or device-related adverse events (AEs). Most AEs were short in duration and 97% were managed without therapy or with nonsurgical interventions. No treatment-related deaths, erosions, extrusions, or device revisions were reported. The most common AE categories were pelvic pain (n = 47) and infection (n = 26). Those subjects experiencing pelvic pain had a mean pain score (0-10 scale, 0 = no pain) during the 12-month follow-up of 1.2 (SD 2.4).The TOPAS system provides significant improvements in FI symptoms and quality of life with an acceptable AE profile and may therefore be a viable minimally invasive treatment option for FI in women.

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.

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.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.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.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.