A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel.

BACKGROUND: An oral dose of 0.75 mg levonorgestrel (LNG) taken shortly after sex was marketed as a routine, nonemergency contraceptive method until the 1990s. Because a hormonal method used only at the time of intercourse may be desirable for women who have infrequent sex, we conducted a study to reevaluate the potential of pericoital LNG as a primary means of contraception. METHODS: We enrolled women aged 18-45 years in Brazil and the USA who expected to have sex 1-4 days per month for 6.5 months. Participants were instructed to take one tablet 0.75 mg LNG within 24 h before or after sex, with no more than one dose in any 24-h period. The primary efficacy measure was the Pearl Index among women aged 18-35 years. RESULTS: The study was stopped after 72 of the planned 300 participants were enrolled due to slow recruitment and related feasibility considerations. In the primary analysis, three pregnancies occurred during 13.4 woman-years of follow-up, resulting in a Pearl Index of 22.4 (95% confidence interval, 4.6-65.4). No serious adverse events were reported, and vaginal bleeding patterns were generally acceptable. CONCLUSIONS: Our estimated Pearl Index was noticeably higher than expected from previous research of LNG for pericoital contraception. Although the regimen was safe and generally acceptable, the study was challenged by slow enrollment and curtailed person-years of follow-up, resulting in poor precision for the estimated treatment effect. Future research may inform whether our results are symptomatic of the regimen, study design or characteristics of the populations from which we recruited. IMPLICATIONS: Our study failed to confirm prior data suggesting that 0.75 mg LNG for pericoital contraception could be more effective than typical use of barrier methods among women having infrequent sex. Characterizing populations most likely to adhere to, and benefit from, pericoital regimens is essential to future research on these methods.

Update on emergency contraception.

Emergency contraception is a woman's last chance to prevent unintended pregnancy. Ulipristal acetate, a selective progesterone receptor modulator, when taken as a single 30 mg dose, is a new, safe and effective emergency contraceptive that can be used from the first day and up to 5 days following unprotected intercourse. The older progesterone-only emergency contraceptive, levonorgestrel, is taken as two 0.75 mg pills 12 hours apart (Next Choice(®); Watson Pharmaceuticals Inc., Morristown, NJ, USA) or a single 1.5 mg pill (Plan B One-Step™; Watson Pharmaceuticals Inc.), and is approved for only 72 hours after unprotected intercourse. During clinical development, ulipristal acetate has been shown to be more effective than levonorgestrel in delaying or inhibiting ovulation. A recent meta-analysis of two randomized clinical trials showed ulipristal acetate to have a pregnancy risk 42% lower than levonorgestrel up to 72 hours and 65% lower in the first 24 hours following unprotected intercourse. Moreover, when taken beyond 72 hours, significantly more pregnancies were prevented with ulipristal acetate than with levonorgestrel. Side effects are mild and similar to those seen with levonorgestrel. Ulipristal acetate was approved for emergency contraception by the US Food and Drug Administration in August 2010, and has been launched in the USA as ella(®) (Watson Pharmaceuticals Inc.) since December 1, 2010. Ella is prescription only and is priced comparable to Plan B One-Step.

Ulipristal acetate: a new emergency contraceptive that is safe and more effective than levonorgestrel.

Ulipristal acetate (UPA), a selective progesterone receptor modulator, when taken as a single 30-mg dose, is safe and effective for emergency contraception up to 5 days (120 h) following unprotected intercourse. This indication has been approved in Europe since May 2009 and was approved by the US FDA in August 2010. The older progesterone-only emergency contraceptive, levonorgestrel (LNG), is approved only up to 72 h after unprotected intercourse. UPA is effective in delaying or inhibiting ovulation, even if taken 24 to 48 h prior to expected ovulation, a time when LNG is no longer effective. A recent meta-analysis of two randomized clinical trials showed UPA to have a pregnancy risk 42% lower than LNG up to 72 h, and 65% lower in the first 24 h following unprotected intercourse. In a randomized trial enrolling women up to 5 days after unprotected intercourse, significantly more pregnancies were prevented with UPA than with LNG when taken beyond 72 h.

Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis.

BACKGROUND: Emergency contraception can prevent unintended pregnancies, but current methods are only effective if used as soon as possible after sexual intercourse and before ovulation. We compared the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception. METHODS: Women with regular menstrual cycles who presented to a participating family planning clinic requesting emergency contraception within 5 days of unprotected sexual intercourse were eligible for enrolment in this randomised, multicentre, non-inferiority trial. 2221 women were randomly assigned to receive a single, supervised dose of 30 mg ulipristal acetate (n=1104) or 1.5 mg levonorgestrel (n=1117) orally. Allocation was by block randomisation stratified by centre and time from unprotected sexual intercourse to treatment, with allocation concealment by identical opaque boxes labelled with a unique treatment number. Participants were masked to treatment assignment whereas investigators were not. Follow-up was done 5-7 days after expected onset of next menses. The primary endpoint was pregnancy rate in women who received emergency contraception within 72 h of unprotected sexual intercourse, with a non-inferiority margin of 1% point difference between groups (limit of 1.6 for odds ratio). Analysis was done on the efficacy-evaluable population, which excluded women lost to follow-up, those aged over 35 years, women with unknown follow-up pregnancy status, and those who had re-enrolled in the study. Additionally, we undertook a meta-analysis of our trial and an earlier study to assess the efficacy of ulipristal acetate compared with levonorgestrel. This trial is registered with ClinicalTrials.gov, number NCT00551616. FINDINGS: In the efficacy-evaluable population, 1696 women received emergency contraception within 72 h of sexual intercourse (ulipristal acetate, n=844; levonorgestrel, n=852). There were 15 pregnancies in the ulipristal acetate group (1.8%, 95% CI 1.0-3.0) and 22 in the levonorgestrel group (2.6%, 1.7-3.9; odds ratio [OR] 0.68, 95% CI 0.35-1.31). In 203 women who received emergency contraception between 72 h and 120 h after sexual intercourse, there were three pregnancies, all of which were in the levonorgestrel group. The most frequent adverse event was headache (ulipristal acetate, 213 events [19.3%] in 1104 women; levonorgestrel, 211 events [18.9%] in 1117 women). Two serious adverse events were judged possibly related to use of emergency contraception; a case of dizziness in the ulipristal acetate group and a molar pregnancy in the levonorgestrel group. In the meta-analysis (0-72 h), there were 22 (1.4%) pregnancies in 1617 women in the ulipristal acetate group and 35 (2.2%) in 1625 women in the levonorgestrel group (OR 0.58, 0.33-0.99; p=0.046). INTERPRETATION: Ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse. FUNDING: HRA Pharma.

Stress urinary incontinence and counseling and practice of pelvic floor exercises postpartum in low-income Hispanic women.

The purpose of the study was to provide estimates of stress urinary incontinence (SUI) and practice of pelvic floor muscle training (PFMT) postpartum as well as counseling during and after pregnancy among Hispanic women. Two hundred Hispanic women were surveyed 6 months postpartum. Twenty-three percent had SUI with onset primarily during pregnancy (70%). Only 20% had received information regarding SUI and PFMT during pregnancy or postpartum. Most women not counseled wished they were (81%). Less counseling occurred among Hispanic women with lower levels of education (odds ratio [OR]= .39; 95% confidence interval [CI]=0.19-0.82; p=0.02) and those whose primary language was Spanish (OR= .36; 95% CI=0.15-0.87; p=0.02), while higher rates occurred among women with a forceps delivery (OR=2.94; 95% CI=1.06-7.78; p=0.03). Fifty-seven percent of women counseled practiced the exercises. Primary reasons for noncompliance were belief that PFMT would not help (47%), and not understanding the instructions (39%). SUI and PFMT counseling is low among Hispanic women. Most women desire such information, and improvement in performance of PFMT among this group is possible.

The impact of fecal and urinary incontinence on quality of life 6 months after childbirth.

OBJECTIVE: The objective of the study was to investigate the impact of postpartum fecal incontinence (FI) and urinary incontinence (UI) on quality of life (QOL). STUDY DESIGN: Seven hundred fifty-nine primiparous women in the Childbirth and Pelvic Symptoms study were interviewed 6 months postpartum. FI and UI were assessed with validated questionnaires. We measured QOL with SF-12 summary scores, health utility index score (a measure of self-rated overall health), and the modified Manchester Health Questionnaire. RESULTS: Women with FI had worse self-rated health utility index scores (85.1 +/- 9.8 vs 88.0 +/- 11.6, P = .02) and Medical Outcomes Study Short Form Health Survey (SF-12) mental summary scores (46.8 +/- 9.2 vs 51.1 +/- 8.7, P < .0001) than women without FI or flatal incontinence. Women with UI had worse SF-12 mental summary scores (48.3 +/- 9.8 vs 51.6 +/- 7.8, P < .01) and self-rated health utility index scores (84.1 +/- 12.5 vs 88.7 +/- 10.1, P < .01) than women without UI. Women with both FI and UI had the lowest SF-12 mental summary scores (44.5 +/- 9.0). CONCLUSION: Six months after delivery, women experiencing FI or UI reported negative effects on health-related QOL. FI and UI together have a greater impact than either condition alone.

Risk factors for sonographic internal anal sphincter gaps 6-12 months after delivery complicated by anal sphincter tear.

OBJECTIVE: The objective of the study was to identify risk factors for internal anal sphincter (IAS) gaps on postpartum endoanal ultrasound in women with obstetric anal sphincter tear. STUDY DESIGN: This prospective study included 106 women from the Childbirth and Pelvic Symptoms Imaging Supplementary Study who had third- or fourth-degree perineal laceration at delivery and endoanal ultrasound 6-12 months postpartum. Data were analyzed using Fisher's exact and t tests and logistic regression. RESULTS: Mean (+/- SD) age was 27.7 (+/- 6.2) years. Seventy-nine women (76%) were white and 22 (21%) black. Thirty-seven (35%) had sonographic IAS gaps. Risk factors for gaps included fourth- vs third-degree perineal laceration (odds ratio [OR] 15.4, 95% confidence interval [CI] 4.8, 50) and episiotomy (OR 3.3, 95% CI 1.2, 9.1). Black race (OR 0.23, 95% CI 0.05, 0.96) was protective. CONCLUSION: In women with obstetric anal sphincter repairs, fourth-degree tears and episiotomy are associated with more frequent sonographic IAS gaps.

Spanish language translation of pelvic floor disorders instruments.

The purpose of the study is to translate existing measures of pelvic symptoms and quality of life from English into Spanish, facilitating research participation of Hispanic/Latina women. The forward-backward translation protocol was applied then adjudicated by a concordance committee. The measures included the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Medical, Epidemiological, and Social Aspects of Aging (MESA) Questionnaire, Hunskaar Severity Measure, Fecal Incontinence Severity Index and modified Manchester Questionnaire, Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Questionnaire (PISQ), and the Life Orientation Test (LOT). English and Spanish versions were administered to 50 Hispanic/Latina women with pelvic symptoms. Kappa correlations of items and correlation coefficients for scales were computed. Psychometric testing for translations demonstrated good (0.80-0.89), very good (0.90-0.95), or excellent (>0.95) correlations for primary scales of the PFDI, PFIQ, MESA, Hunskaar, PISQ, and LOT. Strict translation techniques and testing yielded valid Spanish translations of instruments assessing pelvic symptoms/functional life impact in women with pelvic floor disorders.

Safety and acceptability with the use of a contraceptive vaginal ring after surgical or medical abortion.

OBJECTIVE: The study was conducted to determine if a contraceptive vaginal ring (CVR) is a safe and acceptable method of contraception when used in the proximate postabortion period following first-trimester surgical or medical abortion. METHODS: A CVR was inserted within 1 week following a medical or surgical abortion. Participants were followed up for 3 months to determine safety and acceptability. Safety was measured by the absence of signs of infection or serious adverse events. Acceptability was assessed by the CVR satisfaction survey, completed at the 3-month follow-up visit. RESULTS: Of 81 participants enrolled in the study, 69 (85%) completed the first-month follow-up visit, and 54 (67%) completed the final 3-month follow-up visit. There were no serious adverse events and no signs of infection on physical exam. Most adverse events were mild and not specifically related to the CVR. Related adverse events were those commonly associated with hormonal contraception use. Eighty-nine percent of participants chose to continue the CVR as their birth control method. CONCLUSION: The CVR is potentially safe and has high acceptability when used in the proximate postabortion period following a first-trimester abortion.

Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial.

BACKGROUND: Non-surgical treatment for stress urinary incontinence (SUI) is recommended as first-line therapy, yet few prospective studies and no randomized trials compare the most common non-surgical treatments for SUI. PURPOSE: To present the design and methodology of the ambulatory treatments for leakage associated with stress (ATLAS) trial, a randomized clinical trial comparing three interventions for predominant SUI in women: intravaginal continence pessary; behavioral therapy (including pelvic floor muscle training and exercise and bladder control strategies); and a combination of the two treatments. METHODS: Treatment outcome measures, collected at 12 weeks and six and 12 months post randomization, include the Patient Global Impression of Improvement (PGI-I), the Stress Incontinence Scale of the Pelvic Floor Distress Inventory (PFDI), seven-day bladder diaries, Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12), Patient Satisfaction Questionnaire (PSQ) and the Medical Outcomes Study Short Form Health Survey (SF-36). LIMITATIONS: The study design reduces most common biases, but some degree of selection bias may remain. CONCLUSION: This trial will provide useful information to help counsel women with stress and mixed incontinence about the relative efficacy and satisfaction with pessary, behavioral therapy and both treatments combined.

Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae: results from a multicenter evaluation of the APTIMA assays for both infections.

BACKGROUND: Vaginal swabs were recently U.S. Food and Drug Administration-cleared for detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) using Gen-Probe Incorporated's APTIMA COMBO2 Assay (AC2). We assessed the APTIMA CT Assay (ACT) for CT, APTIMA GC Assay (AGC) for GC, and AC2 for both organisms using patient- and clinician-collected vaginal swabs. METHOD: Women attending family planning, obstetrics and gynecology, or sexually transmitted disease (STD) clinics had first-catch urines (FCUs), patient-collected vaginal swabs, clinician-collected vaginal swabs, and endocervical swabs tested by ACT, AGC, and AC2. A second endocervical swab and FCU were tested using BD ProbeTec (Becton Dickinson) for CT and GC. We calculated sensitivity and specificity using vaginal swabs to detect CT and GC. RESULTS: Of 1,464 subjects enrolled, 180 had CT and 78 GC. ACT sensitivities and specificities for patient-collected vaginal swabs were 98.3% and 96.5%, respectively; for clinician-collected vaginal swabs, 97.2% and 95.2%, respectively. AGC sensitivities and specificities for patient-collected vaginal swabs were 96.1% and 99.3%, respectively; for clinician-collected vaginal swabs, 96.2% and 99.3%, respectively. AC2 results were similar. If an FCU tested positive for CT or GC, >94% of matching vaginal swabs were positive. Positive endocervical swabs showed slightly less concordance (>90% and >88%, respectively). More infected patients were identified using vaginal swabs than FCUs. With AC2, 171 CT-infected patients were identified using FCUs and 196 using patient-collected vaginal swabs. This difference was more pronounced for CT than for GC. CONCLUSIONS: Vaginal swab specimens allowed sensitive and specific detection of CT and GC in the APTIMA assays. Vaginal swabs identified as many infected patients as endocervical swabs and more than FCUs, and may well be the specimen of choice for screening.

Women find it easy and prefer to collect their own vaginal swabs to diagnose Chlamydia trachomatis or Neisseria gonorrhoeae infections.

BACKGROUND: Self-collected specimens can be used to screen asymptomatic women for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). We surveyed women's opinions on ease and preferences as to sampling after collecting their own vaginal swab and urine and a physician collection of vaginal swab and cervical swab. METHODS: In 7 North American cities, a questionnaire was used for women after they participated in a clinical trial of nucleic acid amplification testing of various specimens. A total of 1,090 women consenting to gynecologic sampling for CT and GC (82% of those sampled) volunteered to complete the survey. We analyzed the data for ease of self-collection and preferences for a vaginal swab, urine, or cervical swab. RESULTS: The average age was 26.6 years; 59.6% were black, 25.5% white, 11% Hispanic, 1.9% Asian, and 2% unknown. Thirty-five percent had more than one sex partner in the past 6 months, 84.9% had been previously tested for a sexually transmitted infection (STI), and 49.2% had experienced an STI. A total of 90.4% found it very easy to self-collect a vaginal swab. This was not influenced by age, education, or study site. Seventy-six percent preferred a vaginal swab over a pelvic examination, 60% over a urine collection, and 94% indicated that they would be tested more often if a vaginal swab was available. CONCLUSION: Self-collected vaginal swabs were easy to collect and patients preferred them over urine and cervical swabs.

Necrotizing fasciitis after tension-free vaginal tape (TVT) placement.

A 62-year-old homemaker underwent an uneventful TVT (tension-free vaginal tape) procedure. Eleven days postoperatively she presented to the Emergency Department with agonizing low abdominal pain, elbow pain, fever, and drainage from her suprapubic puncture sites. Her evaluation was consistent with a diagnosis of necrotizing fasciitis and she was started on antibiotics and taken to surgery for exploration and debridement, where the diagnosis was confirmed. This is the first report of necrotizing fasciitis following TVT placement.