Feasibility of prophylactic salpingectomy during vaginal hysterectomy.

BACKGROUND: The American Congress of Obstetricians and Gynecologists recommends that "the surgeon and patient discuss the potential benefits of the removal of the fallopian tubes during a hysterectomy in women at population risk of ovarian cancer who are not having an oophorectomy," resulting in an increasing rate of salpingectomy at the time of hysterectomy. Rates of salpingectomy are highest for laparoscopic and lowest for vaginal hysterectomy. OBJECTIVE: The primary objective of this study was to determine the feasibility of bilateral salpingectomy at the time of vaginal hysterectomy. Secondary objectives included identification of factors associated with unsuccessful salpingectomy and assessment of its impact on operating time, blood loss, surgical complications, and menopausal symptoms. STUDY DESIGN: This was a multicenter, prospective study of patients undergoing planned vaginal hysterectomy with bilateral salpingectomy. Baseline medical data along with operative findings, operative time, and blood loss for salpingectomy were recorded. Uterine weight and pathology reports for all fallopian tubes were reviewed. Patients completed the Menopause Rating Scale at baseline and at postoperative follow-up. Descriptive analyses were performed to characterize the sample and compare those with successful and unsuccessful completion of planned salpingectomy using Student t test, and χ2 test when appropriate. Questionnaire scores were compared using paired t tests. RESULTS: Among 77 patients offered enrollment, 74 consented (96%), and complete data were available regarding primary outcome for 69 (93%). Mean age was 51 years. Median body mass index was 29.1 kg/m2; median vaginal parity was 2, and 41% were postmenopausal. The indications for hysterectomy included prolapse (78%), heavy menstrual bleeding (20%), and fibroids (11%). When excluding conversions to alternate routes, vaginal salpingectomy was successfully performed in 52/64 (81%) women. Mean operating time for bilateral salpingectomy was 11 (±5.6) minutes, with additional estimated blood loss of 6 (±16.3) mL. There were 8 surgical complications: 3 hemorrhages >500 mL and 5 conversions to alternate routes of surgery, but none of these were due to the salpingectomy. Mean uterine weight was 102 g and there were no malignancies on fallopian tube pathology. Among the 17 patients in whom planned bilateral salpingectomy was not completed, unilateral salpingectomy was performed in 7 patients. Reasons for noncompletion included: tubes high in the pelvis (8), conversion to alternate route for pathology (4), bowel or sidewall adhesions (3), tubes absent (1), and ovarian adhesions (1). Prior adnexal surgery (odds ratio, 2.9; 95% confidence interval, 1.5-5.5; P = .006) and uterine fibroids (odds ratio, 5.8; 95% confidence interval, 1.5-22.5; P = .02) were the only significant factors associated with unsuccessful bilateral salpingectomy. Mean menopause scores improved after successful salpingectomy (12.7 vs 8.6; P < .001). CONCLUSION: Vaginal salpingectomy is feasible in the majority of women undergoing vaginal hysterectomy and increases operating time by 11 minutes and blood loss by 6 mL. Women with prior adnexal surgery or uterine fibroids should be counseled about the possibility that removal may not be feasible.

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

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

Mesh sacrocolpopexy compared with native tissue vaginal repair: a systematic review and meta-analysis.

OBJECTIVE: To systematically review outcomes after mesh sacrocolpopexy compared with native tissue vaginal repairs in women with apical prolapse. DATA SOURCES: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through June 4, 2012. METHODS OF STUDY SELECTION: For anatomic and functional analyses, we included studies comparing mesh sacrocolpopexy to native tissue vaginal repairs with at least 6 months follow-up. The primary outcome was anatomic "success" after surgery. Secondary outcomes were reoperation and symptom outcomes. We included large case series and comparative studies with shorter follow-up to increase power for adverse event analyses. TABULATION, INTEGRATION, AND RESULTS: Evidence quality was assessed with the Grades for Recommendation, Assessment, Development and Evaluation system. Meta-analyses were performed when at least three studies reported the same outcome. We included 13 comparative studies for anatomic success, reoperation, and symptom outcomes. Moderate-quality evidence supports improved anatomic outcomes after mesh sacrocolpopexy; very low-quality evidence shows no differences in reoperation between sacrocolpopexy and native tissue vaginal repairs. Evidence was insufficient regarding which procedures result in improved bladder or bowel symptoms. Low-quality evidence showed no differences in postoperative sexual function. Adverse event data were compiled and meta-analyzed from 79 studies. When including larger noncomparative studies, ileus or small bowel obstruction (2.7% compared with 0.2%, P<.01), mesh or suture complications (4.2% compared with 0.4%, P<.01), and thromboembolic phenomena (0.6% compared with 0.1%, P=.03) were more common after mesh sacrocolpopexy compared with native tissue vaginal repairs. CONCLUSION: When anatomic durability is a priority, we suggest that mesh sacrocolpopexy may be the preferred surgical option. When minimizing adverse events or reoperation is the priority, there is no strong evidence supporting one approach over the other.

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

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

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

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

Patient recall 6 weeks after surgical consent for midurethral sling using mesh.

INTRODUCTION AND HYPOTHESIS: We aimed to determine patient recall of specific surgical risks and benefits discussed during consent for midurethral sling (MUS) surgery immediately after consent and at 6 weeks follow-up. Specifically we sought to determine whether or not women recalled specific risks related to the placement of mesh. METHODS: Surgeons consented patients for MUS in their usual fashion during audio recorded consent sessions. After consent and again at 6 weeks postoperatively, women completed a checklist of risks, benefits, alternatives, and general procedural items covered during consent. In addition, women completed the Decision Regret Scale for Pelvic Floor Disorders (DRS-PFD). Audio files were used to verify specific risks, benefits, alternatives, and procedural items discussed at consent. Recall of specific risks, benefits, and alternatives were correlated with DRS-PFD scores. RESULTS: Sixty-three women completed checklists immediately post consent and at 6 weeks postoperatively. Six-week recall of benefits, alternatives, and description of the operation did not change. Surgical risk recall as measured by the patient checklist deteriorated from 92 % immediately post consent to 72 % at 6 weeks postoperatively (p < .001). Recall of the risk for mesh erosion declined from 91 to 64 % (p < .001). Recall that mesh was placed during the MUS procedure declined from 98 to 84 % (p = .01). DRS-PFD scores were correlated with poorer surgical risk recall and surgical complications (r = .31, p = .02). CONCLUSIONS: Recall of MUS surgery risks deteriorated over time. Specifically, women forgot that mesh was placed or might erode. Further investigations into methods and measures of adequate consent that promote recall of long-term surgical risks are needed.

Antibiotic prophylaxis for selected gynecologic surgeries.

BACKGROUND: Antibiotic prophylaxis for surgery is commonly used and is recommended by multiple organizations. OBJECTIVE: To critically review gynecology-specific data regarding surgical antibiotic prophylaxis in selected benign gynecologic surgeries. SEARCH STRATEGY: MEDLINE and Cochrane databases were searched from inception to July 2010. SELECTION CRITERIA: Randomized controlled trials of benign vaginal, cervical, transcervical, abdominal, or laparoscopic procedures other than hysterectomy comparing prophylactic antibiotic use with placebo or with another antibiotic. Outcomes of interest were postoperative infections, additional treatments, and adverse events. DATA COLLECTION AND ANALYSIS: In total, 19 trials met the inclusion criteria. Studies were individually assessed for methodologic quality, then grouped by procedure and evaluated for evidence quality. MAIN RESULTS: There was no difference in infectious outcome for loop electrosurgical excision, hysteroscopic ablation, or laparoscopy, although evidence quality was poor. Fair evidence supports antibiotic prophylaxis for suction curettage or laparotomy. There were insufficient data regarding vaginal surgery prophylaxis. CONCLUSION: Antibiotic prophylaxis may be beneficial in first-trimester suction curettage and laparotomy. No advantage was found for loop electrosurgical excision, hysteroscopy, or laparoscopic gynecologic surgery. Newer procedures and vaginal surgery lack research and merit study.

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

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

A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding.

STUDY OBJECTIVE: To compare hysterectomy with less-invasive alternatives for abnormal uterine bleeding (AUB) in 7 clinically important domains. DESIGN: Systematic review. SETTING: Randomized clinical trials comparing bleeding, quality of life, pain, sexual health, satisfaction, 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: Systematic review of the literature (from inception to January 2011) comparing hysterectomy with alternatives for AUB treatment. Eligible trials were extracted into standardized forms. Trials were graded with a predefined 3-level rating, and the strengths of evidence for each outcome were evaluated with the Grades for Recommendation, Assessment, Development and Evaluation system. MEASUREMENTS AND MAIN RESULTS: Nine randomized clinical trials (18 articles) were eligible. Endometrial ablation, levonorgestrel intrauterine system, and medications were associated with lower risk of adverse events but higher risk of additional treatments than hysterectomy. Compared to ablation, hysterectomy had superior long-term pain and bleeding control. Compared with the levonorgestrel intrauterine system, hysterectomy had superior control of bleeding. No other differences between treatments were found. CONCLUSION: Less-invasive treatment options for AUB result in improvement in quality of life but carry significant risk of retreatment caused by unsatisfactory results. Although hysterectomy is the most effective treatment for AUB, it carries the highest risk for adverse events.

Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review.

INTRODUCTION AND HYPOTHESIS: This study describes the incidence, risk factors, and treatments of graft erosion, wound granulation, and dyspareunia as adverse events following vaginal repair of pelvic organ prolapse with non-absorbable synthetic and biologic graft materials. METHODS: A systematic review in Medline of reports published between 1950 and November 2010 on adverse events after vaginal prolapse repairs using graft materials was carried out. RESULTS: One hundred ten studies reported on erosions with an overall rate, by meta-analysis, of 10.3%, (95% CI, 9.7 - 10.9%; range, 0 - 29.7%; synthetic, 10.3%; biological, 10.1%). Sixteen studies reported on wound granulation for a rate of 7.8%, (95% CI, 6.4 - 9.5%; range, 0 - 19.1%; synthetic, 6.8%; biological, 9.1%). Dyspareunia was described in 70 studies for a rate of 9.1%, (95% CI, 8.2 - 10.0%; range, 0 - 66.7%; synthetic, 8.9%; biological, 9.6%). CONCLUSIONS: Erosions, wound granulation, and dyspareunia may occur after vaginal prolapse repair with graft materials, though rates vary widely across studies.

Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials.

OBJECTIVES: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions. STUDY DESIGN AND SETTING: Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked "critically important," "important," or "not important" for informing patients' choices. RESULTS: One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events. CONCLUSION: To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed.

Anatomic outcomes of vaginal mesh procedure (Prolift) compared with uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse: a Fellows' Pelvic Research Network study.

OBJECTIVE: The objective of the study was to compare apical support anatomic outcomes following vaginal mesh procedure (VMP) (Prolift) to uterosacral ligament suspension (USLS) and abdominal sacrocolpopexy (ASC). STUDY DESIGN: This multicenter, retrospective chart review compared apical anatomic success (stage 0 or 1 based on point C or D of the Pelvic Organ Prolapse Quantification), level of vaginal apex (point C or D) 3-6 months after prolapse repair at 10 US centers between 2004 and 2007. RESULTS: VMP, USLS, and ASC were performed for 206, 231, and 305 subjects respectively. There was no difference in apical success after VMP (98.8%) compared with USLS (99.1%) or ASC (99.3%) (both P = 1.00) 3-6 months after surgery. The average elevation of the vaginal apex was lower after VMP (-6.9 cm) than USLS (-8.05 cm) and ASC (-8.5 cm) (both P < .001) CONCLUSION: Patients undergoing VMP have similar apical success compared with USLS and ASC despite lower vaginal apex 3-6 month after surgery.

Graft use in transvaginal pelvic organ prolapse repair: a systematic review.

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0-3%), visceral injury (1-4%), urinary infection (0-19%), graft erosion (0-30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.

Urinary incontinence and pelvic organ prolapse: diagnosis and treatment for the primary care physician.

This article outlines a simplified approach to diagnosis and treatment of women with urinary incontinence or pelvic organ prolapse that can be used by primary care physicians to identify patients with these conditions and initiate treatment for basic problems.

Informed consent in gynecologic surgery.

OBJECTIVE: The objective of the study was to describe surgeon self-reported behaviors and descriptions of information given to patients when obtaining surgical consent. STUDY DESIGN: This was a survey of 330 gynecological surgeons. Surgeons rated descriptions of information given to patients as well as behaviors for confirming patient understanding during surgical consent. Mean ratings are compared with repeated-measures multivariate analysis of variance. RESULTS: Forty-four percent of surveys (145 of 330) were returned. Most respondents were male (56%), Caucasian (86%), in academic practices settings (55%), with more than 10 years of experience after residency (53%). Surgeons give very detailed descriptions of risks and alternatives to surgery. Less detailed descriptions are given of the postoperative course, expected benefits of surgery, or functional and anatomic changes after surgery. Surgeons confirm patient understanding most often by asking patients whether they have any questions and rarely evaluate patient literacy. CONCLUSION: Surgeons provide widely varying attention to various issues and topics related to communicating with their patients preoperatively.