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.

A guide for urogynecologic patient care utilizing telemedicine during the COVID-19 pandemic: review of existing evidence.

INTRODUCTION AND HYPOTHESIS: The COVID-19 pandemic and the desire to "flatten the curve" of transmission have significantly affected the way providers care for patients. Female Pelvic Medicine and Reconstructive Surgeons (FPMRS) must provide high quality of care through remote access such as telemedicine. No clear guidelines exist on the use of telemedicine in FPMRS. Using expedited literature review methodology, we provide guidance regarding management of common outpatient urogynecology scenarios during the pandemic. METHODS: We grouped FPMRS conditions into those in which virtual management differs from direct in-person visits and conditions in which treatment would emphasize behavioral and conservative counseling but not deviate from current management paradigms. We conducted expedited literature review on four topics (telemedicine in FPMRS, pessary management, urinary tract infections, urinary retention) and addressed four other topics (urinary incontinence, prolapse, fecal incontinence, defecatory dysfunction) based on existing systematic reviews and guidelines. We further compiled expert consensus regarding management of FPMRS patients in the virtual setting, scenarios when in-person visits are necessary, symptoms that should alert providers, and specific considerations for FPMRS patients with suspected or confirmed COVID-19. RESULTS: Behavioral, medical, and conservative management will be valuable as first-line virtual treatments. Certain situations will require different treatments in the virtual setting while others will require an in-person visit despite the risks of COVID-19 transmission. CONCLUSIONS: We have presented guidance for treating FPMRS conditions via telemedicine based on rapid literature review and expert consensus and presented it in a format that can be actively referenced.

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.

Preemptive analgesia for postoperative hysterectomy pain control: systematic review and clinical practice guidelines.

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.

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.

Nonantimuscarinic treatment for overactive bladder: a systematic review.

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.

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.

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.

Natural orifice vaginal sacrocolpopexy (NOVaS): a cadaver feasibility study.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: Fourteen fresh-frozen cadavers were used. Specialized instruments were developed to optimize visualization and facilitate performance of the procedure. RESULTS: 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. CONCLUSION: Vaginal sacrocolpopexy is feasible in a cadaver model.

Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse".

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.

Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative therapy.

STUDY OBJECTIVE: To develop recommendations in selecting treatments for abnormal uterine bleeding (AUB). DESIGN: Clinical practice guidelines. SETTING: Randomized clinical trials compared bleeding, quality of life, pain, sexual health, satisfaction, the need for subsequent surgery, and adverse events between hysterectomy and less-invasive treatment options. PATIENTS: Women with AUB, predominantly from ovulatory disorders and endometrial causes. INTERVENTIONS: On the basis of findings from a systematic review, clinical practice guidelines were developed. Rating the quality of evidence and the strength of recommendations followed the Grades for Recommendation Assessment, Development, and Evaluation system. MEASUREMENTS AND MAIN RESULTS: This paper identified few high-quality studies that directly compared uterus-preserving treatments (endometrial ablation, levonorgestrel intrauterine system and systemically administered medications) with hysterectomy. The evidence from these randomized clinical trials demonstrated that there are trade-offs between hysterectomy and uterus-preserving treatments in terms of efficacy and adverse events. CONCLUSION: Selecting an appropriate treatment for AUB requires identifying a woman's most burdensome symptoms and incorporating her values and preferences when weighing the relative benefits and harms of hysterectomy versus other treatment options.

Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse.

OBJECTIVE: 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. METHODS: 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 Ba<0 and/or C<0, quality-of-life measures, mesh exposure and mesh- and procedure-related complications. Propensity score stratification was applied. RESULTS: 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%). CONCLUSION: 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. FUNDING SOURCE: This study was sponsored by Boston Scientific and developed in collaboration with FDA personnel from the Office of Surveillance and Biometrics, Division of Epidemiology. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01917968.

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.

Clinical Consensus Statement: Vaginal Energy-Based Devices.

ABSTRACT: 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.

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.

Risk factors leading to midurethral sling revision: a multicenter case-control study.

INTRODUCTION AND HYPOTHESIS: To determine risk factors for sling revision after midurethral sling (MUS) placement. METHODS: 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. RESULTS: 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; p < 0.001) CONCLUSIONS: 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.

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.