Alison Jacoby

Nationwide Use of Laparoscopic Hysterectomy Compared With Abdominal and Vaginal Approaches

OBJECTIVE: To examine factors associated with undergoing laparoscopic hysterectomy compared with abdominal hysterectomy or vaginal hysterectomy. METHODS: This is a cross-sectional analysis of the 2005 Nationwide Inpatient Sample. All women aged 18 years or older who underwent hysterectomy for a benign condition were included. Multivariable analyses were used to examine demographic, clinical, and health-system factors associated with each hysterectomy route. RESULTS: Among 518,828 hysterectomies, 14% were laparoscopic, 64% abdominal, and 22% vaginal. Women older than 35 years had lower rates of laparoscopic than abdominal (odds ratio [OR] 0.85, 95% confidence interval [CI] 0.77–0.94 for age 45–49 years) or vaginal hysterectomy (OR 0.61, 95% CI 0.540.69 for age 45–49 years). The odds of laparoscopic compared with abdominal hysterectomy were higher in the West than in the Northeast (OR 1.77, 95% CI 1.2–2.62). African-American, Latina, and Asian women had 40–50% lower odds of laparoscopic compared with abdominal hysterectomy (P<.001). Women with low income, Medicare, Medicaid, or no health insurance were less likely to undergo laparoscopic than either vaginal or abdominal hysterectomy (P<.001). Women with leiomyomas (P<.001) and pelvic infections (P<.001) were less likely to undergo laparoscopic than abdominal hysterectomy. Women with leiomyomas (P<.001), endometriosis (P<.001), or pelvic infections (P<.001) were more likely to have laparoscopic than vaginal hysterectomy. Laparoscopic hysterectomy had the highest mean hospital charges (

Systematic review of mifepristone for the treatment of uterine leiomyomata

18,821, P<.001) and shortest length of stay (1.65 days, P<.001). CONCLUSION: In addition to age and clinical diagnosis, nonclinical factors such as race/ethnicity, insurance status, income, and region appear to affect use of laparoscopic hysterectomy compared with abdominal hysterectomy and vaginal hysterectomy. LEVEL OF EVIDENCE: III

Obstetric outcomes in women with sonographically identified uterine leiomyomata

OBJECTIVE: To systematically review the effect of mifepristone on uterine leiomyoma size and symptoms and to summarize its adverse effects. DATA SOURCES: A computerized search in MEDLINE, EMBASE, LILACS, and Cochrane databases from 1985 to 2002 and hand searches of conference proceedings from 1995 to 2002 were performed with the search terms “mifepristone” and “leiomyomata” and publication type “clinical trial.” METHODS OF STUDY SELECTION: Titles and abstracts were reviewed by 2 authors; there were no areas of disagreement. Inclusion criteria were clinical trials of daily mifepristone for uterine leiomyomata that measured uterine or leiomyoma volume before and after treatment. TABULATION, INTEGRATION, AND RESULTS: Data from each article were abstracted by 2 reviewers. The search identified 6 before-and-after clinical trials involving a total of 166 women with symptomatic uterine leiomyomata. The subjects received 5 to 50 mg/d of mifepristone for 3 to 6 months. No study was placebo-controlled or blinded. Meta-analytic techniques were not performed due to variation in outcome and mifepristone dose. Daily treatment with all doses of mifepristone resulted in reductions in uterine and leiomyoma volumes ranging from 27% to 49% and 26% to 74%, respectively. Mifepristone treatment reduced the prevalence and severity of dysmenorrhea, menorrhagia, and pelvic pressure. Rates of amenorrhea ranged from 63% to 100%. Transient elevations in transaminases occurred in 4%. Endometrial hyperplasia was detected in 10 (28%) of 36 women screened by endometrial biopsy. CONCLUSION: Published trials of mifepristone showed reduction in leiomyoma size and improvement in symptoms. A notable adverse effect of mifepristone was development of endometrial hyperplasia.

Effect of Noncancerous Pelvic Problems on Health-Related Quality of Life and Sexual Functioning

OBJECTIVE: To examine the association between leiomyomata and complications during pregnancy, delivery, and the puerperium. METHODS: We conducted a retrospective cohort study comparing pregnancy outcomes in women with and without uterine leiomyomata who underwent routine second trimester obstetric ultrasonography and delivered viable infants at a single institution. Potential confounding variables, including maternal age, weight, ethnicity, parity, gestational age, epidural use, and labor induction, were controlled for using multivariate logistic regression techniques. RESULTS: From 1993 to 2003, 15,104 women underwent routine second trimester prenatal ultrasonography, and 401 (2.7%) women were identified with at least 1 leiomyoma. By univariate and multivariate analyses, the presence of leiomyomata was associated with increased risks for cesarean delivery (adjusted odds ratio [AOR] 1.57, 95% confidence interval [CI] 1.16–2.13), breech presentation (AOR 1.64, 95% CI 1.11–2.40), malposition (AOR 1.59, 95% CI 1.18–2.15), preterm delivery (AOR 1.45, 95% CI 1.08–1.96), placenta previa (AOR 1.86, 95% CI 1.02–3.39), and severe postpartum hemorrhage (AOR 2.57, 95% CI 1.54–4.27). Premature rupture of membranes, operative vaginal delivery, chorioamnionitis, and endomyometritis were not associated with leiomyomata. Median length of labor was not different between the 2 groups. When compared with leiomyomata less than 10 cm in size, leiomyomata 10 cm or larger were associated with rates of cesarean delivery that were not statistically different (25% compared with 31%, P = .49). CONCLUSION: Pregnant women with leiomyomata are at increased risk for cesarean delivery, breech presentation, malposition, preterm delivery, placenta previa, and severe post partum hemorrhage. Women with leiomyomata 10 cm or larger achieve a vaginal delivery rate of nearly 70%. These results are useful for preconception and prenatal counseling of women with leiomyomata. LEVEL OF EVIDENCE: II-2

Predictors of hysterectomy use and satisfaction

OBJECTIVE: To assess the effect of abnormal uterine bleeding and pelvic pain and pressure on health-related quality of life and sexual functioning and assess treatment satisfaction. METHODS: This is a cross-sectional study of 1,493 sociodemographically diverse women who were seeking care for noncancerous pelvic problems and who had not undergone hysterectomy. Participants were asked about symptoms, attitudes, health-related quality of life, sexual functioning, and treatment satisfaction. Preference for current health was measured using the time tradeoff metric, which asked respondents to estimate the number of years of life they would be willing to trade off to not have a uterine condition. Multivariable logistic regression was used to identify determinants of treatment satisfaction. RESULTS: Most (82.7%) participants reported a complete lack of or only partial symptom resolution, and 42.3% reported that their pelvic problems interfered with their ability to have and enjoy sex. Mean Short Form-12 Physical (43–49) and Mental (41–44) Component Summary scores were substantially lower than population norms for women aged 40–49 years. Mean current health time tradeoff scores ranged from 0.78 to 0.88. Satisfaction with Western medicines ranged from 31.3% (progestin intrauterine device) to 58.2% (opiates) and with uterine-preserving surgery from 20.0% (dilation and curettage) to 51.0% (myomectomy); 27.7 % of the women who used acupuncture were satisfied. Participants with lower educational attainment, greater symptom resolution, and less interference of pelvic problems with sex were more likely to be satisfied. CONCLUSION: Noncancerous pelvic problems are associated with serious decrements in health-related quality of life and sexual functioning and low rates of treatment satisfaction. LEVEL OF EVIDENCE: II

Neonatal outcomes in women with sonographically identified uterine leiomyomata

OBJECTIVE: To identify static and time-varying sociodemographic, clinical, health-related quality-of-life and attitudinal predictors of use and satisfaction with hysterectomy for noncancerous conditions. METHODS: The Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) was conducted from 1998 to 2008. English-, Spanish-, or Chinese-speaking premenopausal women (n=1,420) with intact uteri who had sought care for pelvic pressure, bleeding, or pain from an academic medical center, county hospital, closed-panel health maintenance organization, or one of several community-based practices in the San Francisco Bay area were interviewed annually for up to 8 years. Primary outcomes were use of and satisfaction with hysterectomy. RESULTS: A total of 207 women (14.6%) underwent hysterectomy. In addition to well-established clinical predictors (entering menopause, symptomatic leiomyomas, prior treatment with gonadotropin-releasing hormone agonist, and less symptom resolution), greater symptom impact on sex (P=.001), higher 12-Item Short Form Health Survey mental component summary scores (P=.010), and higher scores on an attitude measure describing “benefits of not having a uterus” and lower “hysterectomy concerns” scores (P<.001 for each) were predictive of hysterectomy use. Most participants who underwent hysterectomy were very (63.9%) or somewhat (21.4%) satisfied in the year after the procedure, and we observed significant variations in posthysterectomy satisfaction across the clinical sites (omnibus P=.036). Other determinants of postsurgical satisfaction included higher pelvic problem impact (P=.035) and “benefits of not having a uterus” scores (P=.008) before surgery and greater posthysterectomy symptom resolution (P=.001). CONCLUSION: Numerous factors beyond clinical symptoms predict hysterectomy use and satisfaction. Providers should discuss health-related quality of life, sexual function, and attitudes with patients to help identify those who are most likely to benefit from this procedure. LEVEL OF EVIDENCE: II

PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids

Objective. We sought to compare perinatal outcomes between women with and without leiomyomata. Study design. This is a retrospective cohort study comparing neonatal outcomes in women with and without uterine leiomyomata discovered at routine second trimester obstetric ultrasonography, all of whom delivered at a single institution. Potential confounders such as maternal age, parity, race, ethnicity, medical insurance, previous uterine surgery, fetal presentation, length of labor, mode of delivery, presence of placenta previa, placental abruption, chorioamnionitis, and epidural use were controlled for using multivariable logistic regression. Results. From 1993 to 2003, 15,104 women underwent routine second trimester prenatal ultrasonography, with 401 (2.7%) women identified with at least one leiomyoma. By univariate and multivariable analyses, the presence of leiomyomata was associated with statistically significant increased risks for preterm delivery at <34 weeks [adjusted odds ratio (AOR) 1.7, 95% confidence interval (CI) 1.1–2.6], <32 weeks (AOR 1.9, 95% CI 1.2–3.2), and <28 weeks (AOR 2.0, 95% CI 1.1–3.8). An association with increased risk for intrauterine fetal demise (IUFD) was also demonstrated (AOR 2.7, 95% CI 1.0–6.9). When IUFD was examined before and after 32 weeks’ gestation, the finding only persisted at earlier gestational ages (<32 weeks: AOR 4.2, 95% CI 1.2–14.7 vs. >32 weeks: AOR 0.82, 95% CI 0.1–6.2). Conclusion. Regardless of maternal age, ethnicity, and parity, pregnant women with leiomyomata are at increased risk for preterm birth and IUFD. This did not translate to lower birth weight outcomes among term patients, suggesting that LBW is more likely due to preterm birth than growth restriction. These results may be useful for preconception and prenatal counseling of women with leiomyomata.

Coil Embolization of a Tuboovarian Anastomosis before Uterine Artery Embolization to Prevent Nontarget Particle Embolization of the Ovary

OBJECTIVE To evaluate the feasibility of a full-scale placebo-controlled trial of magnetic resonance-guided focused ultrasound for fibroids (MRgFUS) and obtain estimates of safety and efficacy. DESIGN Pilot, randomized, placebo-controlled trial. SETTING University medical center. PATIENT(S) Premenopausal women with symptomatic uterine fibroids. INTERVENTION(S) Participants randomized in a 2:1 ratio to receive MRgFUS or placebo procedure. MAIN OUTCOME MEASURE(S) PRIMARY OUTCOME change in fibroid symptoms from baseline to 4 and 12 weeks after treatment assessed by the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL); secondary outcome: incidence of surgery or procedures for recurrent symptoms at 12 and 24 months. RESULT(S) Twenty women with a mean age of 44 years (±standard deviation 5.4 years) were enrolled, and 13 were randomly assigned to MRgFUS and 7 to placebo. Four weeks after treatment, all participants reported improvement in the UFS-QOL: a mean of 10 points in the MRgFUS group and 9 points in the placebo group (for difference in change between groups). By 12 weeks, the MRgFUS group had improved more than the placebo group (mean 31 points and 13 points, respectively). The mean fibroid volume decreased 18% in the MRgFUS group with no decrease in the placebo group at 12 weeks. Two years after MRgFUS, 4 of 12 women who had a follow-up evaluation (30%) had undergone another fibroid surgery or procedure. CONCLUSION(S) Women with fibroids were willing to enroll in a randomized, placebo-controlled trial of MRgFUS. A placebo effect may explain some of the improvement in fibroid-related symptoms observed in the first 12 weeks after MRgFUS. CLINICAL TRIAL REGISTRATION NUMBER NCT01377519.

Contributions of Hysterectomy and Uterus-Preserving Surgery to Health-Related Quality of Life.

Uterine artery embolization (UAE) is being used more frequently as a primary treatment for uterine leiomyoma. Performing UAE in women who desire future fertility is controversial because of the risks of premature menopause and the undetermined effects on pregnancy. The etiology of ovarian failure after UAE is not yet clearly defined, but one of the leading possibilities is nontarget embolization of the ovaries. In this case report, the authors describe a technique of selective coil embolization of a uterine artery-to-ovarian artery communication before UAE performed specifically to protect the ovary from nontarget embolization.

Symptom resolution after hysterectomy and alternative treatments for chronic pelvic pain: does depression make a difference?

OBJECTIVE: To document the long-term effect of surgical interventions for noncancerous uterine conditions on health-related quality of life. METHODS: The Study of Pelvic Problems, Hysterectomy and Intervention Alternatives, conducted between 1998 and 2008, was a longitudinal study of 1,503 women with intact uteri experiencing abnormal uterine bleeding with or without leiomyomas, chronic pelvic pain, or pressure resulting from leiomyomas. Baseline and follow-up questionnaires included three condition-specific measures (Pelvic Problem Resolution, Pelvic Problem Impact Overall, and Pelvic Problem Impact on Sex) and five generic measures (Short Form-12 Mental and Physical Component Summaries, Current Health Utility, Feelings about Heath, and Satisfaction with Sex). We modeled changes over time in these patient-reported outcomes stratified by the most invasive treatment undergone (hysterectomy [13.7%], uterus-preserving surgery [9.0%], or nonsurgical therapy [77.3%]). RESULTS: Participants in all three groups reported significant improvement on all condition-specific measures and two of the five generic measures (Current Health Utility and Feelings about Health) from enrollment to final interview (all P values <.01). In general, greater improvements were experienced by women who had surgery. Trajectories modeled around the dates of surgery showed dramatic improvements after hysterectomy and, to a lesser degree, after uterus-preserving surgery. Although women who underwent uterus-preserving surgery tended to show immediate improvement, women who underwent hysterectomy experienced a 6-month delay in improvement in some outcomes with trajectories converging by 4 years postsurgery. CONCLUSION: Women seeking care for noncancerous uterine conditions can expect to experience improvement over time. Those who opt for surgery may experience most improvement. Understanding health-related quality-of-life trajectories may enhance counseling for women deciding between hysterectomy and alternative interventions. LEVEL OF EVIDENCE: II