Enabling Technologies for Gynecologic Vaginal Surgery: A Systematic Review.

OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review.

OBJECTIVE: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM). DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov , and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators. METHODS OF STUDY SELECTION: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group. TABULATION, INTEGRATION, AND RESULTS: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO 2 ) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO 2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function. CONCLUSION: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.

Gynecologic surgical skill acquisition through simulation with outcomes at the time of surgery: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the effect of simulation training vs traditional hands-on surgical instruction on learner operative skills and patient outcomes in gynecologic surgeries. DATA SOURCES: PubMed, Embase, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials from inception to January 12, 2021. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, prospective comparative studies, and prospective single-group studies with pre- and posttraining assessments that reported surgical simulation-based training before gynecologic surgery were included. METHODS: Reviewers independently identified the studies, obtained data, and assessed the study quality. The results were analyzed according to the type of gynecologic surgery, simulation, comparator, and outcome data, including clinical and patient-related outcomes. The maximum likelihood random effects model meta-analyses of the odds ratios and standardized mean differences were calculated with estimated 95% confidence intervals. RESULTS: Twenty studies, including 13 randomized controlled trials, 1 randomized crossover trial, 5 nonrandomized comparative studies, and 1 prepost study were identified. Most of the included studies (14/21, 67%) were on laparoscopic simulators and had a moderate quality of evidence. Meta-analysis showed that compared with traditional surgical teaching, high- and low-fidelity simulators improved surgical technical skills in the operating room as measured by global rating scales, and high-fidelity simulators decreased the operative time. Moderate quality evidence was found favoring warm-up exercises before laparoscopic surgery. There was insufficient evidence to conduct a meta-analysis for other gynecologic procedures. CONCLUSION: Current evidence supports incorporating simulation-based training for a variety of gynecologic surgeries to increase technical skills in the operating room, but data on patient-related outcomes are lacking.

The short-term efficacy and safety of fractional CO2 laser therapy for vulvovaginal symptoms in menopause, breast cancer, and lichen sclerosus.

OBJECTIVE: To review the short-term effects and safety of vulvovaginal fractional microablative CO2 laser therapy on atrophy symptoms using validated questionnaires pre- and posttreatment. METHODS: This is a retrospective chart review from January, 2016 to December, 2019 on 139 women with vulvovaginal atrophy symptoms, who completed three treatments about 6 weeks apart. All were >18 years old and nonpregnant. As is the practice in our clinic for all women receiving treatment, they were surveyed prior to the 1st and 3rd treatments with validated questionnaires, Female Sexual Function Index (FSFI) and Vulvovaginal Symptoms Questionnaire (VSQ), as well as a visual analog scale (VAS). Paired t test was completed on the pre- and post FSFI and VAS scores. Pre- and postproportions of the VSQ were evaluated by the Fisher's exact test. Means were presented for each study variable. Multivariable regression analysis was completed on continuous and binomial variables for scores predictors. RESULTS: Mean age was 62 years with a mean follow-up of 13.8 weeks. Concomitant topical estrogen was reported in 53% (n = 74). Breast cancer diagnosis was documented in 27% (n = 38), and lichen sclerosus in 22% (n = 31). All FSFI scores improved (pre: 12.7, post: 19.0, P < 0.001). The VSQ showed 18 of 21 questions significantly improved (P < 0.05). The VAS showed significant improvement in painful intercourse (pre: 6.6, post: 2.4, P < 0.001), and vulvar dryness (pre: 4.6, post: 1.5, P < 0.001). Posttreatments, 17 additional women became sexually active. No major adverse events were reported. CONCLUSIONS: Fractional CO2 laser may be effective and safe for the treatment vulvovaginal atrophy.

Video Summary : http://links.lww.com/MENO/A700 .

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

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

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.

Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis.

OBJECTIVE: Understanding the long-term comparative effectiveness of competing surgical repairs is essential as failures after primary interventions for stress urinary incontinence (SUI) may result in a third of women requiring repeat surgery. STUDY DESIGN: We conducted a systematic review including English-language randomized controlled trials from 1990 through April 2013 with a minimum 12 months of follow-up comparing a sling procedure for SUI to another sling or Burch urethropexy. When at least 3 randomized controlled trials compared the same surgeries for the same outcome, we performed random effects model metaanalyses to estimate pooled odds ratios (ORs). RESULTS: For midurethral slings (MUS) vs Burch, metaanalysis of objective cure showed no significant difference (OR, 1.18; 95% confidence interval [CI], 0.73-1.89). Therefore, we suggest either intervention; the decision should balance potential adverse events (AEs) and concomitant surgeries. For women considering pubovaginal sling vs Burch, the evidence favored slings for both subjective and objective cure. We recommend pubovaginal sling to maximize cure outcomes. For pubovaginal slings vs MUS, metaanalysis of subjective cure favored MUS (OR, 0.40; 95% CI, 0.18-0.85). Therefore, we recommend MUS. For obturator slings vs retropubic MUS, metaanalyses for both objective (OR, 1.16; 95% CI, 0.93-1.45) and subjective cure (OR, 1.17; 95% CI, 0.91-1.51) favored retropubic slings but were not significant. Metaanalysis of satisfaction outcomes favored obturator slings but was not significant (OR, 0.77; 95% CI, 0.52-1.13). AEs were variable between slings; metaanalysis showed overactive bladder symptoms were more common following retropubic slings (OR, 1.413; 95% CI, 1.01-1.98, P = .046). We recommend either retropubic or obturator slings for cure outcomes; the decision should balance AEs. For minislings vs full-length MUS, metaanalyses of objective (OR, 4.16; 95% CI, 2.15-8.05) and subjective (OR, 2.65; 95% CI, 1.36-5.17) cure both significantly favored full-length slings. Therefore, we recommend a full-length MUS. CONCLUSION: Surgical procedures for SUI differ for success rates and complications, and both should be incorporated into surgical decision-making. Low- to high-quality evidence permitted mostly level-1 recommendations when guidelines were possible.

Venous thromboembolism prophylaxis in gynecologic surgery: a systematic review.

OBJECTIVE: To comprehensively review and critically assess the available gynecologic surgery venous thromboembolism prophylaxis literature and provide clinical practice guidelines. DATA SOURCES: MEDLINE and Cochrane databases from inception to July 2010. We included randomized controlled trials in gynecologic surgery populations. Interventions and comparators included graduated compression stockings, intermittent pneumatic compression, unfractionated heparin, and low molecular weight heparin; placebo and routine postoperative care were allowed as comparators. METHODS OF STUDY SELECTION: One thousand two hundred sixty-six articles were screened, and 14 randomized controlled trials (five benign gynecologic, nine gynecologic oncology) met eligibility criteria. In addition, nine prospective or retrospective studies with at least 150 women were identified and provided data on venous thromboembolism risk stratification, gynecologic laparoscopy, and urogynecologic populations. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently screened articles with discrepancies adjudicated by a third. Eligible randomized controlled trials were extracted for these characteristics: study, participant, surgery, intervention, comparator, and outcomes data, including venous thromboembolism incidence and bleeding complications. Studies were individually and collectively assessed for methodologic quality and strength of evidence. Overall incidence of clinical venous thromboembolism was 0-2% in the benign gynecologic population. With use of intermittent pneumatic compression for benign major procedures, venous thromboembolism incidence was less than 1%. No venous thromboembolisms were identified in prospective studies of benign laparoscopic procedures. Overall quality of evidence in the benign gynecologic literature was poor. Gynecologic-oncology randomized controlled trials reported venous thromboembolism incidence (including "silent" venous thromboembolisms) of 0-14.8% with prophylaxis and up to 34.6% without prophylaxis. Fair quality of evidence supports that unfractionated heparin and intermittent pneumatic compression are both superior to placebo or no intervention but insufficient to determine whether heparins are superior to intermittent pneumatic compression for venous thromboembolism prevention. Combining two of three risks (aged 60 years or older, cancer, or personal venous thromboembolism history) substantially elevated the risk of venous thromboembolism. CONCLUSION: Intermittent pneumatic compression provides sufficient prophylaxis for the majority of gynecology patients undergoing benign surgery. Additional risk factors warrant the use of combined mechanical and pharmacologic prophylaxis.

Nongenetic factors associated with stress urinary incontinence.

OBJECTIVE: To explore the role of hereditary and environmental factors on the development of stress urinary incontinence in a large cohort of identical and nonidentical twins. METHODS: This is a large, population-based, classic twin study of twin sisters recruited to complete a health survey at the world's largest annual twins festival during 2003-2008. Concordance rates were calculated and structural equation models were used to estimate the contribution of genetic effects compared with environmental factors toward the development of stress urinary incontinence. RESULTS: Eight hundred eighty-two twin sister pairs (n=1,764), including 765 identical and 117 nonidentical twin sister pairs, completed the questionnaires. Sequential structural equation modeling revealed that common environmental factors contributed 77.6% (95% confidence interval [CI], 41.4-83.8; P<.001) of the variance and unique environmental factors contributed 20.9% (95% CI, 15.8-26.7; P<.001) of the variance. The effect of genetics was not statistically significant at 1.49% (95% CI, 0.0-38.8; P=.46). CONCLUSION: Female stress urinary incontinence is more a consequence of environmental risk factors than heredity. This epidemiologic insight should be considered in preventive health efforts. LEVEL OF EVIDENCE: II.

A Valid Form of the PISQ-12, the PISQ-9, for Use in Comparative Studies of Women With and Without Pelvic Organ Prolapse and/or Urinary Incontinence.

OBJECTIVES: : To test the validity and reliability of a modified short-form Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-9) in a general female population. METHODS: : A cross-sectional survey of 364 sexually active women attending annual gatherings in 2005-06 was conducted. Validated questionnaires were completed, including PISQ-12, Index of Female Sexual Function (IFSF), Pelvic Floor Distress Inventory-20 (PFDI-20), Beck Depression Inventory Second Edition (BDI-II) and Pelvic Pain Urgency/Frequency (PUF) scale. PISQ-12/PISQ-9 scores, for construct validity, were compared with the validated questionnaires, and reliability was assessed with Cronbach's alpha statistic. RESULTS: : PISQ-12/PISQ-9 scores correlated significantly with IFSF scores (Spearman-coefficient, 0.65 and 0.66, respectively, P < 0.0001). Mean PISQ-12/PISQ-9 scores in asymptomatic women were significantly better than those in symptomatic women (PISQ-12: 40.0 ± 4.3 versus 37.1 ± 5.2, P < 0.0001; effect size = 0.65, PISQ-9: 28.1 ± 4.1 versus 25.8 ± 4.8, P < 0.0001, effect size = 0.56). PISQ-12/PISQ-9 scores were worse in women with depressive/bladder-pain symptoms compared with those women without these symptoms. Cronbach's alpha values were 0.73 and 0.72 for PISQ-12 and PISQ-9 scores, respectively. CONCLUSIONS: : PISQ-9 scores strongly correlate with PISQ-12 scores as well as scores of a general sexual-function questionnaire and Cronbach's alpha statistics are acceptable. The PISQ-9 can be reliably used in comparative studies assessing pelvic floor function in women with and without prolapse or incontinence.

Impact of hysterectomy on stress urinary incontinence: an identical twin study.

OBJECTIVE: This study uses the unique properties of twin research design to evaluate whether hysterectomy impacts stress urinary incontinence (SUI). STUDY DESIGN: As part of the Evanston Twins Sister Study, we performed bivariate and multivariate analyses on 83 identical twin pairs discordant for hysterectomy. RESULTS: In bivariate analysis, SUI was less common in women who had prior hysterectomy (P =0.028). Multivariate analysis suggested that SUI was significantly less common after hysterectomy (odds ratio [OR], 0.55, confidence interval [CI], 0.30 to 1.00). Exclusion of twin pairs with a history of pelvic floor defect surgery eliminated the statistical relationship between hysterectomy and SUI (OR, 0.79, CI, 0.4 to 1.40). CONCLUSION: Hysterectomy, when analyzed with all cases, was associated with reduced SUI. When concurrent pelvic floor defect surgeries were excluded from the analysis, we found no relationship between hysterectomy and the risk of SUI afterward.

Is transobturator tape as effective as tension-free vaginal tape in patients with borderline maximum urethral closure pressure?

INTRODUCTION: The purpose of this study was to compare transobturator tape (MONARC) with tension-free vaginal tape in patients with borderline low maximum urethral closure pressure. STUDY DESIGN: Historical cohort analysis of 3-month outcomes in 145 subjects (MONARC = 85; tension-free vaginal tape = 60). A cut-off point of 42 cm H2O for preoperative maximum urethral closure pressure was identified as predictor of success in the entire cohort. The cohort was stratified by sling type and analyzed. Outcome variables included urodynamic stress incontinence, urethral pressure profiles, subjective stress incontinence symptoms, and complications. RESULTS: The relative risk of postoperative urodynamic stress incontinence 3 months after surgery in patients with a preoperative maximum urethral closure pressure of 42 cm or less H2O was 5.89 (1.02 to 33.90, 95% confidence interval) when we compared MONARC with tension-free vaginal tape. Subjects in the MONARC and tension-free vaginal tape groups did not differ significantly in baseline characteristics. We defined subjects as failures if they demonstrated postoperative objective stress incontinence on multichannel urodynamic testing. CONCLUSION: In subjects with maximum urethral closure pressure of 42 cm or less H2O, the MONARC was nearly 6 times more likely to fail than tension-free vaginal tape at 3 months after surgery. Long-term follow-up and randomized controlled trials are needed.