Pregnancy Outcomes After Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT0210094.

Changes in Bone Density in Carriers of BRCA1 and BRCA2 Pathogenic Variants After Salpingo-Oophorectomy.

OBJECTIVE: To evaluate the effect of risk-reducing salpingo-oophorectomy (RRSO) on change in bone mineral density (BMD) in women aged 34-50 years with pathogenic variants in BRCA1 or BRCA2 ( BRCA1 /2). METHODS: The PROSper (Prospective Research of Outcomes after Salpingo-oophorectomy) study is a prospective cohort of women aged 34-50 years with BRCA1 or two germline pathogenic variants that compares health outcomes after RRSO to a non-RRSO control group with ovarian conservation. Women aged 34-50 years, who were planning either RRSO or ovarian conservation, were enrolled for 3 years of follow-up. Spine and total hip BMD were measured by dual-energy X-ray absorptiometry (DXA) scans obtained at baseline before RRSO or at the time of enrollment for the non-RRSO group, and then at 1 and 3 years of study follow-up. Differences in BMD between the RRSO and non-RRSO groups, as well as the association between hormone use and BMD, were determined by using mixed effects multivariable linear regression models. RESULTS: Of 100 PROSper participants, 91 obtained DXA scans (RRSO group: 40; non-RRSO group: 51). Overall, total spine, and hip BMD decreased significantly from baseline to 12 months after RRSO (estimated percent change -3.78%, 95% CI -6.13% to -1.43% for total spine; -2.96%, 95% CI -4.79% to -1.14% for total hip) and at 36 months (estimated percent change -5.71%, 95% CI -8.64% to -2.77% for total spine; -5.19%, 95% CI -7.50% to -2.87% for total hip. In contrast, total spine and hip BMD were not significantly different from baseline for the non-RRSO group. The differences in mean percent change in BMD from baseline between the RRSO and non-RRSO groups were statistically significant at both 12 and 36 months for spine BMD (12-month difference -4.49%, 95% CI -7.67% to -1.31%; 36-month difference -7.06%, 95% CI -11.01% to -3.11%) and at 36 months for total hip BMD (12-month difference -1.83%, 95% CI -4.23% to 0.56%; 36-month difference -5.14%, 95% CI -8.11% to -2.16%). Across the study periods, hormone use was associated with significantly less bone loss at both the spine and hip within the RRSO group compared with no hormone use ( P <.001 at both 12 months and 36 months) but did not completely prevent bone loss (estimated percent change from baseline at 36 months -2.79%, 95% CI -5.08% to -0.51% for total spine BMD; -3.93%, 95% CI -7.27% to -0.59% for total hip BMD). CONCLUSION: Women with pathogenic variants in BRCA1 /2 who undergo RRSO before the age of 50 years have greater bone loss after surgery that is clinically significant when compared with those who retain their ovaries. Hormone use mitigates, but does not eliminate, bone loss after RRSO. These results suggest that women who undergo RRSO may benefit from routine screening for BMD changes to identify opportunities for prevention and treatment of bone loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT01948609.

Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids.

Objective: The aim of this study is to examine complementary and alternative medicine (CAM) use among women with symptomatic uterine fibroids in the United States. Materials and Methods: In this cross-sectional analysis of baseline data from a multicenter, prospective cohort study of premenopausal women undergoing surgery for symptomatic fibroids and who enrolled in the Uterine Leiomyoma Treatment with Radiofrequency Ablation study from 2017 to 2019, we contrast women indicating use of at least one CAM modality specifically for fibroid symptoms against women using CAM for other reasons and CAM nonusers. Multivariable logistic regression models were performed to identify participant characteristics independently associated with CAM use for fibroids. Results: Among 204 women, 55% were Black/African American and the mean age was 42 (standard deviation 6.6) years. CAM use was common (67%), with 42% (95% confidence interval [CI]: 35%-49%) reporting use of CAM specifically to treat fibroid symptoms. Most commonly, CAM treatments used for fibroids were diet (62%) and herbs (52%), while CAM treatments for other reasons were exercise (80%) and massage (43%). On average, each participant who reported CAM use utilized three different types of CAM modalities. In a multivariable model, participants were more likely to use CAM for fibroids if they had pelvic pressure (odds ratio [OR] 2.50, 95% CI: 1.07-5.87, p = 0.04), a body-mass index lower than average (OR 0.76, 95% CI: 0.60-0.97, p = 0.03), and a lower health-related quality of life score (OR 0.61, 95% CI: 0.46-0.81, p = 0.001). Conclusions: In this diverse sample of women with symptomatic fibroids, CAM use was highly prevalent. Our findings highlight the need for providers to query patients about CAM use and understand the role of CAM in fibroid management. ClinicalTrials.gov Identifier: NCT02100904.

Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.

STUDY OBJECTIVE: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. DESIGN: Uncontrolled clinical trial. SETTING: Five academic medical centers across California. PATIENTS: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. INTERVENTIONS: Laparoscopic RFA of leiomyomas. MEASUREMENTS AND MAIN RESULTS: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4-7.5) on a 10-point scale, and 89% of surgeons felt "very or somewhat" confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2-6) after the fourth procedure, with all gynecologists reporting surgical confidence. CONCLUSION: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.

Sleep Quality and Daytime Sleepiness Among Women With Urgency Predominant Urinary Incontinence.

OBJECTIVE: The objective of this study was to examine the strength and direction of the association between urinary symptoms and both poor quality sleep and daytime sleepiness among women with urgency urinary incontinence. METHODS: A planned secondary analysis of baseline characteristics of participants in a multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in ambulatory women self-diagnosed by the 3 Incontinence Questions was performed. Urinary symptoms were assessed by 3-day voiding diaries. Quality of sleep was assessed using the Pittsburgh Sleep Quality Index (PSQI) and daytime sleepiness using the Epworth Sleepiness Scale. RESULTS: Of the 640 participants, mean (SD) age was 56 (±14) years and 68% were white. Participants reported an average of 3.9 (±3.0) urgency incontinence episodes per day and 1.3 (±1.3) episodes of nocturia per night. At baseline, 57% had poor sleep quality (PSQI score, >5) and 17% reported daytime sleepiness (Epworth Sleepiness Scale score, >10). Most women (69%) did not use sleeping medication during the prior month, whereas 13% reported use of sleeping medication 3 or more times per week. An increase in total daily incontinence episodes, total daily urgency incontinence episodes, total daily micturitions, and moderate to severe urge sensations were all associated with higher self-report of poor sleep quality according to the PSQI (all P ≤ 0.01). Higher scores on the Bother Scale and the Health-Related Quality of Life for overactive bladder on the Overactive Bladder Questionnaire were similarly associated with higher rates of poor sleep quality (both P ≤ 0.01). In subgroup analysis of those who took sleeping medications less than twice a week, there was still a significant relationship between incontinence measures and quality of sleep as measured by the PSQI. In multivariable analyses, greater frequency of nighttime urgency incontinence was associated with poor sleep quality (P = 0.03). CONCLUSIONS: Among ambulatory women with urgency urinary incontinence, poor sleep quality is common and greater frequency of incontinence is associated with a greater degree of sleep dysfunction. Women seeking urgency urinary incontinence treatment should be queried about their sleeping habits so that they can be offered appropriate interventions.

Change in Surgical Practice for Women With Leiomyomas After the U.S. Food and Drug Administration Morcellator Safety Communication.

OBJECTIVE: To evaluate the association between the U.S. Food and Drug Administration (FDA) communication discouraging use of power morcellators on changes in surgical practice for women with uterine leiomyomas. METHODS: This is a cross-sectional study using data from 2013 to 2014 in the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgical Databases from Arizona, Florida, Kentucky, and New Jersey. Women with a diagnosis of leiomyomas who underwent hysterectomy or myomectomy were included in the analysis. Multivariable models were used to assess changes in the proportion of hysterectomies performed laparoscopically, vaginally, or by laparotomy in the 15 months before the FDA safety communication in April 2013 (January 2013 to March 2014) to the 9 months after the FDA communication (April to December 2014). Changes in the proportion of women who underwent myomectomy compared with hysterectomy were also evaluated during this time period. RESULTS: There were 77,637 hysterectomy and myomectomy cases analyzed from states with both inpatient and ambulatory surgery data; 59% of patients were outpatients. Overall, there was a 4% (95% CI 3.2-4.8%) decrease in the use of laparoscopic hysterectomy for treatment of uterine leiomyomas from 62% of all hysterectomies before the FDA communication on morcellation to 58% afterward. Changes in surgical practice were more pronounced in the inpatient compared with outpatient setting; inpatient laparoscopic hysterectomy decreased by 7% (95% CI 6.1-7.9%) from 24% to 17% of all hysterectomies with an accompanying increase in abdominal hysterectomy of 8% (95% CI 6.7-8.6%) from 71% to 79%. There were no significant changes in the proportion of women with leiomyomas who underwent myomectomy compared with hysterectomy. CONCLUSION: The FDA communication discouraging the use of power morcellators was associated with a decline in laparoscopy to perform hysterectomy, particularly in the inpatient setting. There was no change in the selection of myomectomy compared with hysterectomy for leiomyoma treatment after the FDA communication.

Modifiers of Response to Treatment With Fesoterodine for Urgency-Predominant Urinary Incontinence in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to identify clinical and demographic characteristics that moderate response to treatment with fesoterodine among women with a diagnosis of urgency-predominant urinary incontinence. METHODS: A multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in community-dwelling women diagnosed by the 3-item Incontinence Questionnaire (3IQ) was previously performed. Participants (N = 645) were randomized to fesoterodine therapy (4-8 mg daily; n = 322) or placebo (n = 323). Urinary incontinence was assessed by 3-day voiding diaries. In this secondary analysis, a "responder" was defined as reduction of 50% or greater in overall incontinence episode frequency compared with baseline. Clinical and demographic characteristics that may moderate treatment response were assessed by testing for interaction between characteristics and intervention in logit models of responders, adjusting for clinical site. RESULTS: Participants' ages were a mean of 56 (SD, 14) years, 68% were white race, and they had a mean of 3.9 (SD, 3.0) urgency incontinence episodes per day. There were no baseline differences in demographic, clinical, or incontinence characteristics between treatment and placebo groups or between responders and nonresponders. There was an increase in the proportion of responders to fesoterodine with increasing age (P = 0.04) and parity (0.04) and among married women (P = 0.03), but no effect modification was observed by race/ethnicity, body mass index, education, employment status, or alcohol or tobacco use. CONCLUSIONS: In ambulatory women with urgency-predominant urinary incontinence, older age, being married, and higher parity significantly moderated and potentiated the effects of pharmacologic therapy on incontinence frequency. This study identifies certain populations who may have increased responsiveness to treatment with antimuscarinic therapy and may be used to inform and guide future therapy.

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

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. 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.

Use of medical, surgical and complementary treatments among women with fibroids.

OBJECTIVE: To examine the use of medical management, uterus-preserving surgery (UPS), and complementary treatments among women with uterine fibroids. STUDY DESIGN: Prospective cohort study of 933 premenopausal women ages 31-54 years with symptomatic fibroids who participated in the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) for an average of 4.3 years (SD 2.5 years). Incident use of fibroid treatments was determined through annual interviews. Linear regression models were used to compare changes in fibroid-related symptoms among women who underwent UPS versus those who did not undergo surgery. RESULTS: Participants were racially and ethnically diverse, with a mean age of 43 years. During study follow-up, 531 participants (57%) did not undergo UPS or hysterectomy, 250 (27%) had at least one UPS, and 152 (16%) underwent hysterectomy. Complementary and alternative treatments were commonly used, including exercise (45%), diet (34%), herbs (37%), and acupuncture (16%): participants reported significant symptom improvement and few side effects with these interventions. In multivariable linear regression models, women who did not undergo surgery during the study reported improvement in dyspareunia (p<.001), pelvic pain (p<.001), and menstrual cramps (p<.001). However, women who underwent UPS reported greater overall resolution of "pelvic problems" compared with women who did not have surgical treatment (difference in change score 1.18 on a four-point Likert scale, p<.001). CONCLUSION: UPS are effective treatments for women with fibroids, but many women use hormonal or complementary treatments and report significant symptom improvement without surgical intervention.

A group-based yoga therapy intervention for urinary incontinence in women: a pilot randomized trial.

OBJECTIVE: The aim of this study is to examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. METHODS: We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (n = 10) consisting of twice weekly group classes and once weekly home practice or a wait-list control group (n = 9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed with 7-day voiding diaries. RESULTS: The mean (SD) age was 61.4 (8.2) years, and the mean baseline frequency of incontinence was 2.5 (1.3) episodes/d. After 6 weeks, the total incontinence frequency decreased by 70% (1.8 [0.9] fewer episodes/d) in the yoga therapy versus 13% (0.3 [1.7] fewer episodes/d) in the control group (P = 0.049). Participants in the yoga therapy group also reported an average of 71% decrease in stress incontinence frequency (0.7 [0.8] fewer episodes/d) compared with a 25% increase in controls (0.2 [1.1] more episodes/d) (P = 0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [1.0] versus 0.5 [0.5] fewer episodes/d; P = 0.20). All women starting the yoga therapy program completed at least 90% of the group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. CONCLUSIONS: Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women.

Urinary incontinence management costs are reduced following Burch or sling surgery for stress incontinence.

OBJECTIVE: The objective of the study was to estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence (UI) management costs at 24 months postoperatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures. STUDY DESIGN: Resources used for UI management (supplies, laundry, dry cleaning) were self-reported by 491 women at baseline and 24 months after surgery, and total out-of-pocket costs for UI management (in 2012 US dollars) were estimated. Data from the 2 surgical groups were combined to examine the change in cost for UI management over 24 months. Univariate and bivariate changes in cost were analyzed using the Wilcoxon signed rank test. Predictors of change in cost were examined using multivariate mixed models. RESULTS: At baseline mean (±SD) age of participants was 53 ± 10 years, and the frequency of weekly UI episodes was 23 ± 21. Weekly UI episodes decreased by 86% at 24 months (P < .001). The mean weekly cost was $16.60 ± $27.00 (median $9.39) at baseline and $4.57 ± $15.00 (median $0.10) at 24 months (P < .001), a decrease of 72%. In multivariate analyses, cost decreased by $3.38 ± $0.77 per week for each decrease of 1 UI episode per day (P < .001) and was strongly associated with greater improvement in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores (P < .001) and decreased 24-hour pad weight (P < .02). CONCLUSION: Following Burch or fascial sling surgery, the UI management cost at 24 months decreased by 72% ($625 per woman per year) and was strongly associated with decreasing UI frequency. Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures.

Contributions of hysterectomy and uterus-preserving surgery to health-related quality of life.

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.

Increased risk of high-grade prostate cancer among infertile men.

BACKGROUND: It has been reported that fatherhood status may be a risk factor for prostate cancer. In the current study, the authors examined the subsequent occurrence of prostate cancer in a cohort of men evaluated for infertility to determine whether male infertility is a risk factor for prostate cancer. METHODS: A total of 22,562 men who were evaluated for infertility from 1967 to 1998 were identified from 15 California infertility centers and linked to the California Cancer Registry. The incidence of prostate cancer was compared with the incidence in an age-matched and geography-matched sample of men from the general population. The risk of prostate cancer in men with and those without male factor infertility was modeled using a Cox proportional hazards regression model. RESULTS: A total of 168 cases of prostate cancer that developed after infertility were identified. Men evaluated for infertility but not necessarily with male factors were not found to have an increased risk of cancer compared with the general population (standardized incidence ratio [SIR], 0.9; 95% confidence interval [95% CI], 0.8-1.1). This risk was found to be highest for men with male factor infertility who developed high-grade prostate cancer (SIR, 2.0; 95% CI, 1.2-3.0). On multivariate analyses, men with male factor infertility were found to be 2.6 times more likely to be diagnosed with high-grade prostate cancer (hazard ratio, 2.6; 95% CI, 1.4-4.8). CONCLUSIONS: Men with male factor infertility were found to have an increased risk of subsequently developing high-grade prostate cancer. Male infertility may be an early and identifiable risk factor for the development of clinically significant prostate cancer.

Predictors of hysterectomy use and satisfaction.

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.

Increased risk of testicular germ cell cancer among infertile men.

BACKGROUND: The risk of testicular cancer is thought to be higher among men seeking infertility treatment compared with the general population. Confirmation of this risk in a large US cohort of at-risk patients is lacking. This study explored the association between male infertility and subsequent development of testicular cancer in a US-based cohort. METHODS: A total of 51 461 couples evaluated for infertility from 1967 to 1998 were recruited from 15 California infertility centers. We linked data on 22 562 identified male partners to the California Cancer Registry. The incidence of testicular cancer in this cohort was compared with the incidence in an age-matched sample of men from the general population using the Surveillance Epidemiology and End Results program. We analyzed the risk for testicular cancer in men with and without male factor infertility using a Cox proportional hazards regression model. RESULTS: Thirty-four post-infertility-diagnosis cases of histologically confirmed testicular cancer were identified. Men seeking infertility treatment had an increased risk of subsequently developing testicular cancer (standardized incidence ratio, 1.3; 95% confidence interval, 0.9-1.9), with a markedly higher risk among those with known male factor infertility (2.8; 1.5-4.8). In multivariable analysis, men with male factor infertility were nearly 3 times more likely to develop testicular cancer compared with those without (hazard ratio, 2.8; 95% confidence interval, 1.3-6.0). CONCLUSION: Men with male factor infertility have an increased risk of subsequently developing testicular cancer, suggesting the existence of common etiologic factors for infertility and testicular cancer.

Effect of noncancerous pelvic problems on health-related quality of life and sexual functioning.

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.

Bed rest after embryo transfer: a randomized controlled trial.

OBJECTIVE: To determine whether bed rest after embryo transfer leads to improved pregnancy rates (PR). DESIGN: Randomized controlled trial. SETTING: University reproductive health clinic. PATIENT(S): Women undergoing IVF. INTERVENTION(S): Patients undergoing 164 cycles of IVF were randomized to 30 minutes of bed rest after embryo transfer or immediate discharge from the clinic. MAIN OUTCOME MEASURE(S): Clinical PR defined by visualized fetal heart beat and ongoing PR defined by viable intrauterine gestation beyond 11 weeks. RESULT(S): The clinical and ongoing PR for both groups were 50% and 46.3%, respectively, with no statistically significant difference between the two groups. CONCLUSION(S): Thirty minutes of bed rest after embryo transfer does not improve PR.

Potential association between infertility and spinal neural tube defects in offspring.

BACKGROUND: We examined the possible association between infertility and spinal neural tube defects (NTDs). METHODS: This is a nested case-control study within the Kaiser Permanente Medical Care Program (KPMCP) in Northern California. Among a birth cohort of 110,624 singleton infants > or = 36 weeks gestation, 1994-1997, we electronically identified cases of spinal NTDs and confirmed the diagnosis by chart review. Controls (n = 1,608) were randomly selected from the birth population. History of infertility was defined as: (1) physician diagnosis of infertility; (2) prescription for an infertility medication noted in the KPMCP pharmacy; and/or (3) evaluation at 1 of 15 infertility clinics in Northern California. RESULTS: Eighteen infants diagnosed with spinal NTDs (prevalence 1.6/10,000) included 13 with spina bifida cystica and 5 with spina bifida occulta. Case mothers were more likely to have a history of infertility (4/18 vs. 96/1,608, OR 4.3, 95% CI 1.01-14.0), and to have been prescribed clomiphene citrate within the window spanning 60 days before to 15 days after conception (3/18 vs. 32/1,608, OR 11.7, 95% CI 2.0-44.8). CONCLUSION: This exploratory study suggests that infertility may be associated with an increased risk of spinal NTDs among liveborn, term infants.

Accuracy of obstetric diagnoses and procedures in hospital discharge data.

OBJECTIVE: The objective of the study was to estimate the validity of obstetric procedures and diagnoses in California patient discharge data. STUDY DESIGN: We randomly sampled 1611 deliveries from 52 of 267 California hospitals that performed more than 678 eligible deliveries in 1992 to 1993. We compared hospital-reported procedures and diagnoses against our recoding of the same records. RESULTS: Cesarean, forceps, and vacuum delivery were accurately reported, with sensitivities and positive predictive values exceeding 90%. Episiotomy was underreported (70% sensitivity). Cesarean indications were reported with at least 60% sensitivity, except uterine inertia, herpes, and long labor. Among comorbidities, sensitivity exceeded 60% for chorioamnionitis, diabetes, premature labor, preeclampsia, and intrauterine death. Sensitivity was poor (less than 60%) for anemia, asthma, thyroid disorders, mental disorders, drug abuse, genitourinary infections, obesity, fibroids, excessive fetal growth, hypertension, premature rupture, polyhydramnios, and postdates. CONCLUSION: The validity of hospital-reported obstetric procedures and diagnoses varies, with moderate to high accuracy for some codes but poor accuracy for others.

Instrumental variables technique: cigarette price provided better estimate of effects of smoking on SF-12.

OBJECTIVE: Debate surrounds the usefulness of the instrumental variables (IV) technique for medical research. The choice of an instrument for the technique has been contentious. This study estimated the effects of smoking on physical functional status. We chose an especially valid and strong instrument: cigarette price. STUDY DESIGN AND SETTING: The data were a nationally representative cross-sectional sample of 34,288 persons aged 30 to 91 in 1996-1997. The sample was drawn from the Community Tracking Study. Number of cigarettes smoked per day was predicted by the average cigarette price for the state in which the subject resided. The outcome measure was physical functional status and was measured by the SF-12 physical functional index. RESULTS: In multivariable models we found the following: cigarettes per day was strongly and negatively associated with the SF-12 index (P<.001); cigarette price was strongly and negatively associated with cigarettes per day (P=.002); the predicted cigarettes per day (the IV) was strongly and negatively associated with the SF-12 index in linear regression and tobit regression (P=.047 and P=.021). CONCLUSION: Estimated coefficients from the IV method suggested that the effect of smoking on physical functional status was substantially larger than estimates that relied on conventional methods.