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Objective: To assess efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas.Methods: This phase 3, double-blind, placebo-controlled study enrolled premenopausal women (aged 18-50 years) with abnormal uterine bleeding, one or more discrete leiomyomas, and uterine size 20 weeks of gestation or less. Patients were randomized 1:1:1 to 5 mg ulipristal, 10 mg ulipristal, or placebo once daily for 12 weeks followed by 12-week drug-free follow-up. Coprimary endpoints were rate of and time to amenorrhea, defined as no bleeding for the last 35 consecutive days of treatment. Secondary endpoints included rates of amenorrhea from day 11 and change from baseline to endpoint in the Revised Activities subscale of the Uterine Fibroid Symptom and Quality of Life questionnaire, which includes questions pertaining to physical and social activities. Safety assessments included adverse event monitoring and endometrial biopsies. A sample size of 150 was planned to compare separately each dose of ulipristal with placebo.Results: From March 2014 to March 2016, 157 patients were randomized. Demographics were similar across treatment groups. Amenorrhea was achieved by 25 of 53 (47.2% [97.5% CI 31.6-63.2]) and 28 of 48 (58.3% [97.5% CI 41.2-74.1]) patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 1 of 56 (1.8% [97.5% CI 0.0-10.9]) placebo-treated patients (both P<.001). Time to amenorrhea was shorter for both ulipristal doses compared with placebo (P<.001), and both doses of ulipristal resulted in improved quality of life compared with placebo (P<.001). Common adverse events (5% or greater in either ulipristal group during treatment) were hypertension, elevated blood creatinine phosphokinase, and hot flushes. Serious adverse events occurred in four patients, but none was considered related to treatment. Endometrial biopsies were benign.Conclusion: Ulipristal at 5 mg and 10 mg were well tolerated and superior to placebo in rate of and time to amenorrhea in women with symptomatic uterine leiomyomas.Clinical Trial Registration: Clinicaltrials.gov number, NCT02147197. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To understand whether using oral contraceptive pills (OCPs) results in temporary interruption of bleeding for etonogestrel contraceptive implant users during a 14-day course. METHODS: In this double-blind trial, we randomly assigned etonogestrel implant users reporting 7 consecutive days or more of bothersome bleeding to receive 14 pills of study drug (150 microgram levonorgestrel and 30 microgram ethinyl estradiol combined OCPs) or an identical-appearing placebo. The primary outcome was the proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of therapy. Prespecified secondary outcomes were number of days until temporary interruption of bleeding occurred, number of days without bleeding during therapy, and number of days to recurrence of bleeding after discontinuation of therapy. We hypothesized that temporary interruption of bleeding would occur in 80% of the treatment group compared with 20% in the control group; using 80% power, we needed a sample size of 26 women. We performed intent-to-treat analysis. RESULTS: From November 2013 through December 2014, 66 women were screened and 32 were randomized: OCPs (n=16) or placebo (n=16). The majority was young, Caucasian women with reported bleeding as extremely or very annoying; groups had similar baseline characteristics. Participants randomized OCPs were more likely (14 of 16 [87.5%±16.2%] compared with six of 16 [37.5%±23.7%]) to have a temporary interruption of bleeding during the study drug period (odds ratio 11.7, 95% confidence interval 1.9–70.2). Of women in the OCP arm who had a temporary interruption, 85.7% had bleeding recurrence within 10 days after treatment. CONCLUSION: Bothersome bleeding in etonogestrel contraceptive implant users will usually stop with 14-day OCP treatment, but bleeding most often resumes within days of treatment cessation. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01968135. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the association between the use of gelatin-thrombin matrix and the development of pelvic abscess during hysterectomy as well as factors associated with surgeons' use of this product. METHODS: Data for patients undergoing hysterectomy for obstetric-gynecologic pathology were abstracted from databases at a tertiary hospital between 2009 and 2012. Open and minimally invasive hysterectomies were included and vaginal hysterectomies were excluded. Blood loss, surgery type, comorbidities, abscess formation, and use of gelatin-thrombin matrix were examined. Abscess was defined as a walled-off fluid collection (documented with computed tomography scan) with fever (greater than 38°C) or leukocytosis (greater than 11,000/microliter). Standard statistical models were used. RESULTS: Of the 413 patients identified, 213 (51%) underwent surgery for malignancy. Gelatin-thrombin matrix was used in 166 patients (40%). The overall rate of abscess was low (3%). In bivariate analyses, blood loss greater than 500 mL (odds ratio [OR] 3.9, 95% confidence interval [CI] 1.1-12.9, P=.021], ascites (OR 6.5, 95% CI 1.6-26.1, P=.023), drain placement (OR 4.5, 95% CI 1.3-15.1, P=.009), and gelatin-thrombin matrix use (OR 7.0, 95% CI 1.5-32.9, P=.009) were significantly associated with abscess formation. Multivariate logistic regression revealed that only gelatin-thrombin matrix use predicted the development of pelvic abscess (OR 7.0, 95% CI 1.5-32.9, P=.013). CONCLUSION: We found that gelatin-thrombin matrix use was associated with an increased risk of pelvic abscess. Although these products are important in the setting of bleeding, these data suggest that the liberal use of sealants is not without risk. [ABSTRACT FROM AUTHOR]

Vaginal hysterectomy fulfills the evidence-based requirements as the preferred route of hysterectomy for benign gynecologic disease. Despite proven safety and effectiveness, the vaginal approach for hysterectomy has been and remains underused in surgical practice. Factors associated with underuse of vaginal hysterectomy include challenges during residency training, decreasing case numbers among practicing gynecologists, and lack of awareness of evidence supporting vaginal hysterectomy. Strategies to improve resident training and promote collaboration and referral among practicing physicians and increasing awareness of evidence supporting vaginal hysterectomy can improve the primary use of this hysterectomy approach. [ABSTRACT FROM AUTHOR]

The article discusses surgical management for Leiomyomas to preserve uterine and fertility in women. Topics include surgical approaches including myomectomy, hysteroscopy, and laparoscopy, the need for preoperative imaging for a successful minimally invasive procedures, and the role played by robotic technology in improving surgical outcomes.

The article presents a study which estimates the variation of oophorectomy in women who undergo hysterectomy for benign indications. The study uses Perspective database, hierarchical mixed-effects regression models, and sensitivity analysis to determine the rates of ovarian preservation in women. Results show that the rate of ovarian conservation in younger women is increasing than in older women.

The article presents research which analyzed the risk associated with the use of prophylaxis and venous thromboembolism among women. The researchers examined the predictors and patterns of venous thromboembolism prophylaxis in the U.S. from 2003 to 2007. They found that women who are undergoing laparoscopic hysterectomy are at low risk for this medical condition.

In the article, the author discusses the role played by hysterectomy in the treatment of acute pelvic pain in women. She claims that chronic pelvic pain is experienced by almost 15% of women and could account for over two billion dollars in health care costs annually in the U.S. alone. She cites several additional treatment options for chronic pelvic pain including hormonal therapy, physical therapy and neural blocks.

The article offers clinical information on uterine leiomyomas. Leiomyomas is said to be prevalent among African American women, but the lack of standardized nomenclature and classification makes the clinical care and research of leiomyomas difficult. A discussion on the clinical heterogeneity of the biology and pathology of leiomyoma is presented. In addition, the article cites the indications for minimally invasive therapies for leiomyomas.

The article explores the benefits and risks of endometriosis management that involves medical and surgical therapy for adult women who are symptomatic with pelvic pain or infertility or both. It presents a background of the incidence, clinical manifestations, and etiology of endometriosis. Clinical considerations and recommendations are cited, including the limited value of excision of deeply infiltrating endometriosis.

The article presents a study which compares the efficacy of daily gentamicin to eight-hour gentacimin in treating intrapartum chorioamnionitis. Women with chorioamnionitis were divided into two groups and were treated either with daily or eight-hour gentacimin. Ampicillin was also administered to both groups and those who underwent ceasarian delivery also received clidamycin. The study reveals that the two gentacimin treatments are equally effective in curing intrapartum chorioamnionitis.

The article offers information on von Willebrand disease in women. In the U.S., roughly three million women with menorrhagia have bleeding disorders, in which von Willebrand disease is the most common. It notes that women with von Willebrand disease are at high risk for obstetric and gynecologic complications. It also mentions that there are various treatments for menorrhagia in women with von Willebrand disease however, the first-line therapy is still the hormonal contraception.

The article presents a study which investigates the efficacy of botulinum neurotoxin type A injections in the treatment of vaginismus and vulvar vestibular syndrome. Outpatients with stable levator ani muscle hyperactivity showed in electromyogram (EMG) were recruited and had undergone repeated cycles of botulinum neurotoxin type A injections. Results showed that butolinum improved sexual activity and is effective in the treatment of vaginismus secondary to vulvar vestibular syndrome.

The article offers information on the diagnosis and clinical management of polycystic ovary syndrome (PCOS), a disorder among women characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovaries. Environmental and genetic causes of PCOS have not been identified and its treatment is largely based on symptoms. It presents clinical manifestations of PCOS which is usually in the form of menstrual disorders. It discusses the use of progestins and gonadotropins for PCOS treatment.

The article assesses three strategies for diagnosing women at risk for ectopic pregnancy based on information collected at initial presentation. The strategies used were logistic regression, a numeric scoring system and a classification and regression tree. The researchers found that a scoring system based on five factors, namely age, ectopic history, bleeding, prior miscarriage and human chorionic gonadotropin level, is effective in predicting outcomes of women at risk for ectopic pregnancy.

The article discusses the discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms in women aged 18 years and older. The researchers found 49,419 episodes of anticholinergic therapy available for analysis from 29,369 women and the median time for overall anticholinergic drug discontinuation was 4.76 months.

The article presents a study which evaluated the clinical efficacy and tolerability of topical gabapentin in the treatment of women with vulvodynia in the U.S. It is a restrospective study which designed to ascertain clinical responses to topical gabapentin. It is showed that topical gabapentin seems to be well-tolerated and associated with significant pain relief in women with vulvodynia.

The article discusses the results of a study in 6 women that investigated the effect of a single oral 150-mg dose of flucanozole on the prothrombin time (PT) of women on long-term warfarin therapy. The PT increased 11% at day 2, 34% at day 5, and 2% on day 8. A single 150-mg dose fluconazole may increase the PT to a clinically relevant level in a woman on chronic warfarin therapy.

OBJECTIVE: To investigate the efficacy of botulinum toxin injection to treat women with moderate and severe vaginismus. METHODS: Twenty-four women referred to our clinic from February 2002 to February 2004 (mean age 25 years; range 19-34 years) with third- to fourth-degree vaginismus were recruited for this study. These women had previous unsuccessful treatments. Botulinum toxin (150-400 mIU) was injected into the puborectalis muscles in 3 sites on each side of the vagina. RESULTS: Twenty-three patients (95.8%) had vaginal examinations 1 week postoperatively that showed little or no vaginismus, 18 (75%) achieved satisfactory intercourse after the first injection, 4 (16.7%) had mild pain, 1 was cured after a second injection, 1 patient refused vaginal examination and did not attempt to have coitus, and another had no coitus as a result of her husband's secondary impotence. The women were followed up for a mean of 12.3 months (range 2-24 months), and there were no cases of recurrence. CONCLUSION: In refractory cases of vaginismus when conventional therapies have failed, local injection of botulinum toxin can be considered. [ABSTRACT FROM AUTHOR]

OBJECTIVE:To compare the effect of individual pelvic floor muscle training with and without biofeedback in women with urodynamic stress incontinenceMETHODS:The study was a single, blind, randomized trial. All women completed 6 months of pelvic floor muscle training comprising three sets of ten contractions three times per day, supervised by a physical therapist. One group trained with a biofeedback apparatus at home, the other without biofeedback. The primary outcome measures were pad test with standardized bladder volume and self-report of severity.RESULTS:A total of 103 women were randomized, and data from 94 women were analyzed. Mean age (range) was 46.6 (30–70) years, and mean (range) duration of symptoms was 9.7 (1–25) years. Seventy women had urodynamic stress incontinence alone, and 24 women reported additional urge symptoms. Women training with and without biofeedback showed a statistically significant reduction in leakage on pad test (P < .01) after 6 months of pelvic floor muscle training. Objective cure (2 g or less of leakage) in the total group was 58% in women training with and 46% in women training without biofeedback, and in the subgroup of women with urodynamic stress incontinence alone, 69% in women training with and 50% in women training without biofeedback. There was no statistically significant difference between the groups posttreatment in any outcome measure.CONCLUSION:Cure rate was high, and the reduction in urinary leakage after treatment was statistically significant in both groups. However, there was no statistically significant difference in the effect of individual pelvic floor muscle training with and without biofeedback. [Copyright &y& Elsevier]

The article focuses on the study about symptomatic enterocele. Intricately, it investigates a case of a middle-aged woman with reports of fecal urgency, incomplete bowel evacuation, and recurrent pelvic organ prolapse presented for surgical correction of a posterior vaginal defect. The study concludes that repair of symptomatic pelvic organ relapse revealed underlying chylous ascites and lymphoma.

A response by Elizabeth A. Stewart to a letter to the editor about her article "Sustained relief of leiomyoma symptoms by using focused ultrasound surgery," is presented.

Presents a response by Cheng Yu Long and Eing Mei Tsai to a letter to the editor about their article on lateral excision of tension-free vaginal tape for the treatment of iatrogenic urethral obstruction, featured in the journal "Obstetrics & Gynecology."

Presents a letter to the editor about lateral excision of tension-free vaginal tape for the treatment of iatrogenic urethral obstruction, featured in the journal "Obstetrics & Gynecology."

A letter to the editor is presented in response to the article "Sustained relief of leiomyoma symptoms by using focused ultrasound surgery," by E.A. Stewart and colleagues in the 2007 issue.